Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dapagliflozin · 65 trials · 28 indications
Study participants received dapagliflozin 10 mg or matching placebo, given once daily in addition to SoC. Overall, the mean study duration was 12.0 months (time in study until last visit) with an accumulated 4023.9 participant-years. The maximum study duration for any participant was 29 months. "Number of Events" for NYHA corresponds to the number of participants with a non-missing value for NYHA functional class at the last visit, and that all participants with a non-missing value take part in the analysis comparing their NYHA class value with all other participants with a NYHA value, according to the win-ratio method.
Change from baseline in KCCQ-TSS was defined as the endpoint value at week 16 minus the baseline value. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-TSS incorporates the symptom frequency (4 items) and symptom burden (3 items) domains into a single summary score. The score is transformed to a range of 0-100, in which a higher score reflects better health status. Baseline value is the last value on or prior to the randomization visit. Deaths are treated as the worst outcome and ordering among deaths is based on last value while alive. In rank ANCOVA and HL estimation, multiple imputation was performed on missing values for participants who were alive at the visit at week 16 but did not have KCCQ-TSS values.
Change from baseline in KCCQ-PLS was defined as the endpoint value at week 16 minus the baseline value. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-PLS incorporates the 6 physical limitation items into a single score. The score is transformed to a range of 0-100, in which a higher score reflects better health status. Baseline value is the last value on or prior to the randomization visit. Deaths are treated as the worst outcome and ordering among deaths is based on last value while alive. Deaths are treated as the worst outcome and ordering among deaths is based on last value while alive. In rank ANCOVA and HL estimation, multiple imputation was performed on missing values for participants who were alive at the visit at week 16 but did not have KCCQ-PLS values.
Change from baseline in 6-minute walk distance (6MWD) (exercise capacity) at week 16 was defined as the distance walked in 6 minutes at week 16 minus the baseline value. Baseline value is the last value on or prior to the randomization visit. Deaths are treated as the worst outcome and ordering among deaths is based on last value while alive. In rank ANCOVA and HL estimation, multiple imputation was performed on missing values for participants who were alive at the visit at week 16 but did not have 6MWD values.
Change from baseline in KCCQ-TSS was defined as the endpoint value at week 16 minus the baseline value. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ-TSS incorporates symptom frequency (4 items) and symptom burden (3 items) domains into a single score. The score is transformed to a range of 0-100 (higher score reflects better health status). Baseline value is the last value on or prior to the randomization visit. Deaths are treated as the worst outcome and ordering among deaths is based on last value while alive. In rank ANCOVA and HL estimation, multiple imputation was performed on missing values for participants alive at the week 16 visit but without KCCQ-TSS values. All the data for the endpoint, except for death, collected during COVID-19, are set as missing and imputed same way as pre-COVID-19 missing data.
Change from baseline in 6-minute walk distance (6MWD) (exercise capacity) at week 16 was defined as the distance walked in 6 minutes at week 16 minus the baseline value. Baseline value is the last value on or prior to the randomization visit. Deaths are treated as the worst outcome and ordering among deaths is based on last value while alive. In rank ANCOVA and HL estimation, multiple imputation was performed on missing values for participants who were alive at the visit at week 16 but did not have 6MWD values.
Dual primary efficacy Primary endpoint analysed in all patients randomised (Full analysis set). The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Dual primary efficacy Primary endpoint analysed in all patients randomised with LVEF \< 60% at baseline. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data.
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set. Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication.
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).
The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.
Safety and co-primary efficacy
Co-primary efficacy
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure
To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure
To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.
Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period.
Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.
HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.
Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the Double-Blind Period.
To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.
Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.
HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Insulin sensitivity was estimated by measuring circulating insulin concentrations after a 12 hour fast and after ingesting 75 g of glucose. Insulin was measured 0, 30, 60, 90 and 120 minutes after glucose ingestion. Time point 0 minutes is reported below.
Blood pressure was measured with an automatic machine at baseline. Numbers are reported as systolic/diastolic
Participants answered a satiety questionnaire before liquid meal primer, immediately post liquid meal primer, 60 minutes post liquid primer, immediately post breakfast buffet, 60 minutes, 120 minutes and 180 minutes post breakfast buffet. Responses how full do you feel right now? for 60 minutes post liquid meal primer ingestion are reported below. This was determined by using a visual analog scale. The left side of the analog scale represents a null answer (e.g. How full do you feel right now)? Answer 0: Not full at all. The right side of the line represented the strongest answer in the opposite direction (e.g. How full to you feel right now)? Answer 100: Extremely full. The length of the line is 100 mm, thus the scale ranges for all answers were 0-100. All values are reported as values between 0 and 100. If the answers to the fullness questions increased, this represented a decreased desire to eat.
Participants answered a hunger questionnaire before liquid meal primer, immediately post liquid meal primer, 60 minutes post liquid primer, immediately post breakfast buffet, 60 minutes, 120 minutes and 180 minutes post breakfast buffet. Responses to how hungry do you feel right now? for 60 minutes post liquid meal primer ingestion are reported below. This was determined by using a visual analog scale. The left side of the analog scale represents a null answer (e.g. How hungry do you feel right now? Answer 0: Not hungry at all. The right side of the line represented the strongest answer in the opposite direction (e.g. How full to you feel right now)? Answer 100: Extremely hungry. The length of the line is 100 mm, thus the scale ranges for all answers were 0-100. All values are reported as values between 0 and 100. If the answers to the fullness questions increased, this represented an increased desire to eat.
Will be analyzed using a commercially available biochemical assay.
Will be analyzed using a commercially available biochemical assay.
Will be analyzed using a commercially available biochemical assay.
Will be analyzed using a commercially available biochemical assay.
Will be analyzed using a commercially available biochemical assay.
Will be analyzed using a commercially available biochemical assay.
Will be analyzed using a commercially available biochemical assay.
Will be analyzed using a commercially available biochemical assay.
Will be analyzed using a commercially available biochemical assay.
HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model.
UACR was analysed at baseline and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. UACR values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.
To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.
7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.
To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration.
To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration.
To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration.
Collection of clinical data regarding the treatment of two doses of 10mg dapagliflozin as add-on to night and day closed-loop control using the DreaMed Algorithm and the time within glucose range 70-180 mg/dl (3.9-10mmol/l) \[%\]
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).
The 24-hour period is defined based on the morning void, from the first morning void to the one of the next day.
No statistical analysis will be performed
No statistical analysis will be performed
No statistical analysis will be performed
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL).
Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).
Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng\*hr/mL).
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng\*h/mL).
Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.
Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min).
Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)
| Arm | Type | Description |
|---|---|---|
| Dapagliflozin | EXPERIMENTAL | Patients will be randomized 1:1 to either dapagliflozin or placebo |
| Placebo | PLACEBO_COMPARATOR | Placebo matching dapagliflozin |
| Low dose Dapagliflozin | EXPERIMENTAL | Oral route. Start with a low dose of dapagliflozin administered once daily and remain on the low dose regardless of your HbA1c at week 12. |
| Low dose/high dose Dapagliflozin | EXPERIMENTAL | Oral route. Start with a low dose of Dapagliflozin administered once daily and up titrate to the high dose Dapagliflozin administered once daily if HbA1c \>= 7% at week 12 |
| Low dose Saxagliptin | EXPERIMENTAL | Oral route. Start with a low dose of saxagliptin administered once daily and remain on the low dose regardless of your HbA1c at week 12 |
| Low dose/high dose Saxagliptin | EXPERIMENTAL | Oral route. Start with a low dose of saxagliptin administered once daily and up titrate to the high dose if HbA1c \>= 7% at week 12 |
| Placebo arm | PLACEBO_COMPARATOR | Oral route. Placebo tablets administered for 52 weeks |
| Dapagliflozin placebo | PLACEBO_COMPARATOR | - |
| Saxagliptin+Dapagliflozin+Metformin | ACTIVE_COMPARATOR | 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin |
| Dapagliflozin+Saxagliptin placebo+Metformin | ACTIVE_COMPARATOR | 5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo |
| Saxagliptin+Dapagliflozin placebo+metformin | ACTIVE_COMPARATOR | 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo |
| dapagliflozin 5mg + insulin | EXPERIMENTAL | dapagliflozin tablet 5mg + adjustable insulin |
| dapagliflozin 10mg + insulin | EXPERIMENTAL | dapagliflozin tablet 10mg + adjustable insulin |
| Dapagliflozin 5 mg | EXPERIMENTAL | Dapagliflozin 5 mg tablet orally, once daily for 52 weeks |
| Dapagliflozin 10 mg | EXPERIMENTAL | Dapagliflozin 10 mg tablet orally, once daily for 52 weeks |
| Arm A: Dapagliflozin | EXPERIMENTAL | Dapagliflozin 5 mg tablet orally, once daily for 52 weeks |
| Arm B: Dapagliflozin | EXPERIMENTAL | Dapagliflozin 10 mg tablet orally, once daily for 52 weeks |
| Arm C: Placebo for Dapagliflozin | PLACEBO_COMPARATOR | Placebo tablet orally, once daily for 52 weeks |
| Group 1: Dapagliflozin | EXPERIMENTAL | Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin |
| Group 2: Dapagliflozin Placebo | PLACEBO_COMPARATOR | Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin |
| Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR | EXPERIMENTAL | - |
| Arm 2: Placebo + Saxagliptin + Metformin IR | EXPERIMENTAL | - |
| Dapagliflozin 10 mg tablet | EXPERIMENTAL | - |
| matching placebo tablet | PLACEBO_COMPARATOR | - |
| Open label treatment | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | Dapagliflozin 5 mg |
| 2 | EXPERIMENTAL | Dapagliflozin 10 mg |
| 3 | PLACEBO_COMPARATOR | - |
| 4 | PLACEBO_COMPARATOR | Placebo plus open-label metformin |
| Placebo matching Dapagliflozin | PLACEBO_COMPARATOR | Placebo tablets matching dapagliflozin tablets |
| Dapagliflozin, 10 mg | EXPERIMENTAL | Oral tablets administered as 10 mg once daily for up to 12 weeks |
| Placebo-matching dapagliflozin | PLACEBO_COMPARATOR | Oral tablets administered once daily in the morning |
| Dapagliflozin, 2. 5 mg | EXPERIMENTAL | Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8) |
| Dapagliflozin, 5 mg | EXPERIMENTAL | Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8) |
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| Group 3 | EXPERIMENTAL | - |
| Dapagliflozin + Metformin XR | EXPERIMENTAL | Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks |
| Dapagliflozin + Placebo | EXPERIMENTAL | Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks. Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks. |
| Metformin XR + Placebo | ACTIVE_COMPARATOR | Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks |
| A | EXPERIMENTAL | Dapagliflozin 10 mg plus Metformin |
| B | PLACEBO_COMPARATOR | Placebo plus Metformin |
| Dapagliflozin 1 mg | EXPERIMENTAL | Dapagliflozin: 1 mg |
| Dapagliflozin 2.5 mg | EXPERIMENTAL | Dapagliflozin: 2.5 mg |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| Placebo + Metformin | PLACEBO_COMPARATOR | Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks |
| Dapagliflozin, 2.5 mg + Metformin | EXPERIMENTAL | Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks |
| Dapagliflozin, 5 mg + Metformin | EXPERIMENTAL | Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks |
| Dapagliflozin, 10 mg + Metformin | EXPERIMENTAL | Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks |
| Group 1: Dapagliflozin, 2.5 mg AM | EXPERIMENTAL | Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. |
| Group 1: Dapagliflozin, 10 mg AM | EXPERIMENTAL | Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. |
| Group 1: Dapagliflozin 2.5 mg PM | EXPERIMENTAL | Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. |
| Group 1: Dapagliflozin, 5 mg PM | EXPERIMENTAL | Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. |
| Group 1: Dapagliflozin, 10 mg PM | EXPERIMENTAL | Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. |
| Group 2: Dapagliflozin, 5 mg AM | EXPERIMENTAL | Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. |
| Group 2: Dapagliflozin, 10 mg AM | EXPERIMENTAL | Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. |
| Group 1: Dapagliflozin placebo AM & PM | EXPERIMENTAL | Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. |
| Group 1: Dapaglifozon, 5 mg AM | EXPERIMENTAL | Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. |
| Dapagliflozin with dietary counseling | EXPERIMENTAL | Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. |
| Placebo with dietary counseling | PLACEBO_COMPARATOR | Daily oral administration of placebo tablet with dietary counseling to promote weight loss. |
| Metformin | ACTIVE_COMPARATOR | Metformin, 2 x 850 mg per day |
| Exercise | ACTIVE_COMPARATOR | Exercise, interval training |
| Control | NO_INTERVENTION | No intervention |
| Dapagliflozin 10mg | EXPERIMENTAL | Tablets administered orally once daily for 24 weeks |
| Dapagliflozin 10mg + Saxagliptin 2.5mg | EXPERIMENTAL | Tablets administered orally once daily for 24 weeks |
| Omega-3 carboxylic acids 4g / day | EXPERIMENTAL | - |
| Dapagliflozin, 10mg / day | EXPERIMENTAL | - |
| Omega-3 carboxylic acids 4g/day+Dapagliflozin 10mg/day | EXPERIMENTAL | - |
| Arm 1: Dapagliflozin (1 mg) | EXPERIMENTAL | - |
| Arm 2: Dapagliflozin (2.5 mg) | EXPERIMENTAL | - |
| Arm 3: Dapagliflozin (5 mg) | EXPERIMENTAL | - |
| Arm 4: Dapagliflozin (10 mg) | EXPERIMENTAL | - |
| Arm 5: Placebo matching Dapagliflozin | EXPERIMENTAL | - |
| Hydrochlorothiazide | ACTIVE_COMPARATOR | - |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Dapagliflozin (10 mg) | ACTIVE_COMPARATOR | - |
| Dapagliflozin (5 mg) | ACTIVE_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | 20 mg |
| Cohort 2 - Arm 1 | EXPERIMENTAL | 10 mg |
| Cohort 2 - Arm 2 | EXPERIMENTAL | 20 mg |
| Cohort 2 - Arm 3 | PLACEBO_COMPARATOR | - |
| Arm 4 | EXPERIMENTAL | - |
| Arm 5 | EXPERIMENTAL | - |
| Arm 6 | PLACEBO_COMPARATOR | - |
| Arm 7 | ACTIVE_COMPARATOR | - |
| Cohort 1 Treatment A | EXPERIMENTAL | Single-dose of saxagliptin (2.5 mg), dapagliflozin (5 mg), metformin (1000 mg) XR (Extended-release) FDC (Fixed-dose combination) tablet administered orally under fasted condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state. The treatment sequences are (ABC), (ACB), (BAC), (BCA), (CAB) or (CBA). |
| Cohort 1 Treatment B | EXPERIMENTAL | Single-dose of saxagliptin (2.5 mg), dapagliflozin (5 mg), metformin (850 mg) XR FDC tablet, administered orally under fasted condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state. The treatment sequences are (ABC), (ACB), (BAC), (BCA), (CAB) or (CBA). |
| Cohort 1 Treatment C (Reference product) | ACTIVE_COMPARATOR | Single-dose of Onglyza® (2.5 mg saxagliptin), Forxiga® (5 mg dapagliflozin) and Glucophage XR® (2 x 500 mg metformin XR) co-administered under fasted condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state. The treatment sequences are (ABC), (ACB), (BAC), (BCA), (CAB) or (CBA). |
| Cohort 2 Treatment D | EXPERIMENTAL | Single-dose of saxagliptin (2.5 mg), dapagliflozin (5 mg), metformin (1000 mg) XR FDC tablet administered orally under fed condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state The treatment sequences are (DEF), (DFE), (EDF), (EFD), (FDE) or (FED). |
| Cohort 2 Treatment E | EXPERIMENTAL | Single-dose of saxagliptin (2.5 mg), dapagliflozin (5 mg), metformin (850 mg) XR FDC tablet, administered orally under fed condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state. The treatment sequences are (DEF), (DFE), (EDF), (EFD), (FDE) or (FED). |
| Cohort 2 Treatment F (Reference Product) | ACTIVE_COMPARATOR | Single-dose of Onglyza® (2.5 mg saxagliptin), Forxiga® (5 mg dapagliflozin) and Glucophage XR® (2 x 500 mg metformin) co-administered under fed condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state. The treatment sequences are (DEF), (DFE), (EDF), (EFD), (FDE) or (FED). |
| Cohort 3 Treatment G | EXPERIMENTAL | Single-dose dapagliflozin (5 mg) / metformin (1000 mg) XR FDC tablet administered orally under fed condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state. The treatment sequences are (GHI), (GIH), (HGI), (HIG), (IHG) or (IGH). |
| Cohort 3 Treatment H | EXPERIMENTAL | Single-dose dapagliflozin (5 mg) / metformin (850 mg) XR FDC tablet administered orally under fed condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state. The treatment sequences are (GHI), (GIH), (HGI), (HIG), (IHG) or (IGH). |
| Cohort 3 Treatment I (Reference Product) | ACTIVE_COMPARATOR | Single-dose Forxiga® (5 mg dapagliflozin) and Glucophage XR® (2 x 500 mg metformin) co-administered under fed condition. Within each cohort, subjects will be randomized to 1 of 6 treatment sequences, each subject will receive 3 single-dose treatments in either a fasted or fed-state. The treatment sequences are (GHI), (GIH), (HGI), (HIG), (IHG) or (IGH). |
| Placebo Oral Tablets | PLACEBO_COMPARATOR | two administrations identical to the experimental drug |
| dapagliflozin 5mg | EXPERIMENTAL | dapagliflozin tablet 5mg |
| Dapagliflozin (T2DM) | ACTIVE_COMPARATOR | - |
| Dapagliflozin (Healthy Subjects) | ACTIVE_COMPARATOR | - |
| dapagliflozin (0.001 mg) | EXPERIMENTAL | Cohort 1 |
| dapagliflozin (0.01 mg) | EXPERIMENTAL | Cohort 2 |
| dapagliflozin (0.1 mg) | EXPERIMENTAL | Cohort 3 |
| dapagliflozin (0.3 mg) | EXPERIMENTAL | Cohort 4 |
| dapagliflozin (1 mg) | EXPERIMENTAL | Cohort 5 |
| dapagliflozin (2.5 mg) | EXPERIMENTAL | Cohort 6 |
| FDC of dapagliflozin/metformin XR | OTHER | - |
| FDC of dapagliflozin/reduced mass metformin XR | OTHER | - |
| dapagliflozin and Glucophage® XR | OTHER | - |
| Dapagliflozin + Warfarin | ACTIVE_COMPARATOR | - |
| Warfarin | ACTIVE_COMPARATOR | - |
| Dapagliflozin + Digoxin | ACTIVE_COMPARATOR | - |
| Digoxin | ACTIVE_COMPARATOR | - |
| Glimepiride | ACTIVE_COMPARATOR | - |
| Dapagliflozin + Glimepiride | ACTIVE_COMPARATOR | - |
| Sitagliptin | ACTIVE_COMPARATOR | - |
| Dapagliflozin + Sitagliptin | ACTIVE_COMPARATOR | - |
| simvastatin | ACTIVE_COMPARATOR | - |
| Dapagliflozin + simvastatin | ACTIVE_COMPARATOR | - |
| valsartan | ACTIVE_COMPARATOR | - |
| Dapagliflozin + valsartan | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Dapagliflozin | DRUG | Dapagliflozin 10 mg tablets given once daily, per oral use |
| Placebo | DRUG | Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use |
| Saxagliptin | DRUG | Tablets, Oral, 2.5mg Once daily Tablets, Oral, 5mg, Once daily |
| Dapagliflozin placebo | DRUG | matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension. |
| Placebo for Dapagliflozin | DRUG | Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet |
| Placebo for Saxagliptin | DRUG | Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet |
| Dapagliflozin 5 mg | DRUG | Dapagliflozin, a blood glucose lowering drug. Oral dose |
| Dapagliflozin 10mg | DRUG | Dapagliflozin, a blood glucose lowering drug. Oral dose |
| Dapagliflozin 10 mg | DRUG | Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy |
| Matching Placebo for Dapagliflozin | DRUG | Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks |
| Placebo tablet | DRUG | Oral dose (od) |
| Placebo matching with Dapagliflozin | DRUG | Tablets, Oral, 0 mg, Once daily, Up to 52 weeks |
| Metformin immediate release (IR) | DRUG | Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks |
| metformin | DRUG | \>/= 1500 mg total daily dose, tablets taken orally, twice daily |
| Placebo matching Dapagliflozin | DRUG | Tablets, Oral, 0 mg, once daily, Up to 12 weeks |
| Placebo-matching dapagliflozin | DRUG | Oral tablets administered as 0 mg once daily for up to 12 weeks |
| Pioglitazone | DRUG | Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks |
| Metformin XR | DRUG | Tablets, Oral, up to 2000 mg, once daily, 24 weeks |
| dapagliflozin matching Placebo | DRUG | Tablets |
| metformin HCl Modified Release matching Placebo | DRUG | Tablets |
| Sitagliptin | DRUG | Tablet oral 100 mg total daily dose once daily rescue medication |
| Thiazolidinedione (Pioglitazone) | DRUG | Tablets, ≥ 30 mg, Once daily, up to 48 weeks |
| Glimepiride | DRUG | tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks |
| metformin hydrochloride | DRUG | rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice |
| pioglitazone hydrochloride | DRUG | rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice |
| Rosiglitazone | DRUG | rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice |
| glipizide | DRUG | Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks |
| Dapagliflozin Tablet | DRUG | Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study. |
| Exercise | BEHAVIORAL | Interval training, 5 times per week, 30 min per session |
| Saxagliptin 2.5 mg | DRUG | Tablets administered orally once daily for 24 weeks. |
| Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg | DRUG | Tablets administered orally once daily for 24 weeks. |
| Omega-3 carboxylic acids | DRUG | 4 g administered as 4 x 1 g capsules |
| Hydrochlorothiazide | DRUG | Tablets, Oral, 25 mg, once daily, 12 weeks |
| 2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet | DRUG | Used in Treatment B and Treatment E. |
| 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet | DRUG | Used in Treatment A and Treatment D. |
| 5 mg dapagliflozin / 850 mg metformin XR FDC | DRUG | Used in Treatment H. |
| 5 mg dapagliflozin / 1000 mg metformin XR FDC | DRUG | Used in Treatment G. |
| 2.5 mg ONGLYZA® (saxagliptin) tablet | DRUG | Used in treatments C and F. |
| 5 mg Forxiga® (dapagliflozin) tablet | DRUG | Used in treatments C, F and I. |
| 500 mg Glucophage XR® | DRUG | Used in treatments C, F and I. |
| Placebo Oral Tablet | DRUG | two administrations in the evening and 12 hours later |
| Dapagliflozin 5mg | DRUG | Dapagliflozin, a blood glucose lowering drug. Oral dose |
| Dapagliflozin + Glucophage tablet fasted | DRUG | Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state |
| Dapagliflozin/metformin IR FDC tablet fasted | DRUG | single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state |
| Dapagliflozin + Glucophage tablet fed | DRUG | Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state |
| Dapagliflozin/metformin IR FDC tablet fed | DRUG | single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state |
| Glucophage | DRUG | Tablets, Oral, 1000 mg, Single Dose |
| Warfarin | DRUG | Tablets, Oral, 25 mg, Single Dose |
| Digoxin | DRUG | Tablets, Oral, 0.25, Single Dose |
| simvastatin | DRUG | Tablets, Oral, 20 mg, Single Dose |
| valsartan | DRUG | Tablets, Oral, 320 mg, Single Dose |
| Dapagliflozin + Glimepiride | DRUG | Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose |
| Dapagliflozin + Metformin | DRUG | Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg |
Inclusion Criteria: * Participant must be ≥18 at the time of signing the informed consent * Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019), within the preceding 7 days, or 10 days if earlier randomisation is not feasible * Evidence of ...
Dapagliflozin is an investigational small molecule being developed for cardiovascular and metabolic conditions, including diabetes mellitus, chronic kidney disease, heart failure with preserved ejection fraction, and type 1 diabetes mellitus. It is also studied in healthy volunteers for bioequivalence assessments. The drug is in Phase 3 clinical development.
Dapagliflozin is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
Dapagliflozin is in Phase 3 clinical development. It has completed 20 clinical trials with a total enrollment of 17,379 participants. The trials are randomized, double-blind, and placebo-controlled, indicating a rigorous evaluation process for the drug's efficacy and safety.
Dapagliflozin has completed several clinical trials, including NCT01294436 in Japanese subjects with type 2 diabetes, NCT02279407 for liver fat in diabetic patients, NCT03877237 for heart failure with reduced ejection fraction, and NCT04856007 for bioequivalence in healthy Chinese subjects. All trials are completed.
Dapagliflozin is also known by the brand name Farxiga, which is a medication used to treat type 2 diabetes. In clinical trials, it is being studied for additional indications such as heart failure and chronic kidney disease. The drug is developed by AstraZeneca.