Recent Updates
Recently added Catalysts

Dapagliflozin

Phase 3

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Oct 31, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials20
Total Enrollment6,263
FDA Designations
No designations recorded
Clinical Trials (20)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02681094A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 DiabetesPHASE3 COMPLETED 905Feb 26, 2016Jul 15, 2017Oct 10, 2018110 United States, Canada +4
NCT02413398A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 DiabetesPHASE3 COMPLETED 321Jun 15, 2015Nov 7, 2017Oct 31, 201887 United States, Bulgaria +6
NCT01392677Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and SulfonylureaPHASE3 COMPLETED 311Oct 1, 2011Aug 1, 2013Mar 12, 201442 Canada, Czechia +4
NCT01042977Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular DiseasePHASE3 COMPLETED 964Mar 1, 2010Dec 1, 2012Feb 17, 2014135 United States, Argentina +8
NCT01031680Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and HypertensionPHASE3 COMPLETED 922Feb 1, 2010Dec 1, 2012Oct 29, 2013140 United States, Argentina +7
NCT00859898Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 DiabetesPHASE3 COMPLETED 1,093Apr 1, 2009May 1, 2010Jul 7, 2016123 United States, India +4
NCT00855166Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 DiabetesPHASE3 COMPLETED 182Feb 1, 2009Dec 1, 2011Oct 14, 201321 Bulgaria, Czechia +3
NCT00736879Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 DiabetesPHASE3 COMPLETED 497Sep 22, 2008Dec 29, 2009Apr 20, 201762 United States, Canada +5
NCT00976495Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 DiabetesPHASE2 COMPLETED 154Oct 1, 2009Nov 1, 2010Mar 8, 201712 United States, Canada +1
NCT00972244Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus PatientsPHASE2 COMPLETED 417Aug 1, 2009May 1, 2010Oct 14, 201320 Japan
NCT00831779Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 DiabetesPHASE2 COMPLETED 116Apr 1, 2009Aug 1, 2010Apr 24, 20173 United States
NCT03138356Bioequivalence Study of Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR (Extended-release) and Dapagliflozin / Metformin XR Relative to Individual Components in Healthy SubjectsPHASE1 COMPLETED 126May 25, 2017Nov 28, 2017Dec 7, 20171 United Kingdom
NCT01535677To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered SeparatelyPHASE1 COMPLETED 71Apr 1, 2013Jul 1, 2013Jul 9, 20151 United Kingdom
NCT01525238PK Study of Dapagliflozin in Pediatric Subjects With T2DMPHASE1 COMPLETED 53Jul 1, 2012Sep 1, 2014May 30, 201717 United States, Mexico
NCT01165268Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)PHASE1 COMPLETED 24Aug 1, 2010Dec 1, 2010Nov 17, 20161 United States
NCT01055652Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus PatientsPHASE1 COMPLETED 28Jan 1, 2010Apr 1, 2010Oct 17, 20112 Japan
NCT00908271Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy SubjectsPHASE1 COMPLETED 7Jul 1, 2009Aug 1, 2009Oct 17, 20161 United States
NCT00904176Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy SubjectsPHASE1 COMPLETED 30Jun 1, 2009Aug 1, 2009Oct 17, 20161 United States
NCT00842556Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy SubjectsPHASE1 COMPLETED 18Mar 1, 2009May 1, 2009Oct 17, 20161 United States
NCT00839683Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy SubjectsPHASE1 COMPLETED 24Feb 1, 2009Mar 1, 2009Oct 17, 20161 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline in HbA1c at Week 24
Baseline and week 24

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.

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Baseline, Week 24

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 Levels
Baseline to week 24

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.

Adjusted Mean Change in HbA1c Levels
Baseline to Week 24

To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.

Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
Baseline to Week 24

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 From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants
Week 24

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.

Adjusted Mean Change in Total Body Weight
Baseline to Week 24

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 From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
Baseline (Day 1), Week 24

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.

Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])
From Baseline to Week 12

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.

Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])
From Baseline to Week 12

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.

PK assessment: AUC (Area under plasma concentration-time curve from time zero to infinity)
At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)

To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration.

PK assessment: AUC0-t (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration)
At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)

To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration.

PK assessment: Cmax (Maximum observed plasma concentration)
At Pre-dose, 0.25, 0.5, 1, 1.5, 2,3,4,6,8,12, 18, 24,36, 48, 60 and 72 hours (Days 1 to 4)

To measure the PK exposure for saxagliptin, 5-hydroxy saxagliptin (where applicable), dapagliflozin and metformin using plasma concentrations in subjects following IMP administration.

Area under the curve over the time (AUC)
pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

No statistical analysis will be performed

AUC from time zero to the time of last quantifiable analyte concentration (AUC(0-t))
pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

No statistical analysis will be performed

Maximum concentration (Cmax)
pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

No statistical analysis will be performed

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin
11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

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).

Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin
11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).

Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin
11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

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).

Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin
11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

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).

Mean Plasma Half-life (T-HALF) of Dapagliflozin
11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.

Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin
11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

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 (Vz/F) of Dapagliflozin
11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

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)

The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
Before 7 days of oral administration of 10 mg of dapagliflozin
To evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessment of AUC and Cmax of dapagliflozin
Plasma samples will be collected through Visit 4 (up to 72 hours = 3 days after dose) for PK assessment for period 1. Plasma samples will be collected through Visit 7 (up to 72 hours = 3 days after dose) for PK assessment for period 2.
Absolute oral bioavailability
Within the 3 days after study drug administration
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
216 hours post-dose
Secondary Endpoints
Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks
Baseline and week 24
Change in Fasting Plasma Glucose at 24 Weeks
Baseline and week 24
Change in Total Body Weight at 24 Weeks
Baseline and week 24
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Saxagliptin+Dapagliflozin+MetforminACTIVE_COMPARATOR5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin
Dapagliflozin+Saxagliptin placebo+MetforminACTIVE_COMPARATOR5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo
Saxagliptin+Dapagliflozin placebo+metforminACTIVE_COMPARATOR5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo
DapagliflozinEXPERIMENTAL10 mg Tablets, Oral, Once daily, 24 weeks
PlaceboPLACEBO_COMPARATORMatching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
Dapagliflozin 10 mg tabletEXPERIMENTAL -
matching placebo tabletPLACEBO_COMPARATOR -
1EXPERIMENTALdapagliflozin 10 mg tablet
2PLACEBO_COMPARATORmatching placebo tablet
Dapagliflozin + Metformin XREXPERIMENTALDapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
Dapagliflozin + PlaceboEXPERIMENTALDapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks. Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
Metformin XR + PlaceboACTIVE_COMPARATORMetformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
AEXPERIMENTALDapagliflozin 10 mg plus Metformin
BPLACEBO_COMPARATORPlacebo plus Metformin
Dapagliflozin 1 mgEXPERIMENTALDapagliflozin: 1 mg
Dapagliflozin 2.5 mgEXPERIMENTALDapagliflozin: 2.5 mg
Dapagliflozin 5 mgEXPERIMENTALDapagliflozin: 5 mg
HydrochlorothiazideACTIVE_COMPARATOR -
3EXPERIMENTAL5mg dapagliflozin
4EXPERIMENTAL10mg dapagliflozin
5PLACEBO_COMPARATORPlacebo
Cohort 1 Treatment AEXPERIMENTALSingle-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 BEXPERIMENTALSingle-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_COMPARATORSingle-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 DEXPERIMENTALSingle-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 EEXPERIMENTALSingle-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_COMPARATORSingle-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 GEXPERIMENTALSingle-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 HEXPERIMENTALSingle-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_COMPARATORSingle-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).
Dapagliflozin 10 mgEXPERIMENTAL -
Dapagliflozin (T2DM)ACTIVE_COMPARATOR -
Dapagliflozin (Healthy Subjects)ACTIVE_COMPARATOR -
Dapagliflozin + WarfarinACTIVE_COMPARATOR -
WarfarinACTIVE_COMPARATOR -
Dapagliflozin + DigoxinACTIVE_COMPARATOR -
DigoxinACTIVE_COMPARATOR -
GlimepirideACTIVE_COMPARATOR -
Dapagliflozin + GlimepirideACTIVE_COMPARATOR -
SitagliptinACTIVE_COMPARATOR -
Dapagliflozin + SitagliptinACTIVE_COMPARATOR -
simvastatinACTIVE_COMPARATOR -
Dapagliflozin + simvastatinACTIVE_COMPARATOR -
valsartanACTIVE_COMPARATOR -
Dapagliflozin + valsartanACTIVE_COMPARATOR -
Interventions
NameTypeDescription
DapagliflozinDRUG5mg, orally, Green, plain, diamond-shaped, film-coated tablet
Placebo for DapagliflozinDRUGDoes not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet
SaxagliptinDRUG5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
Placebo for SaxagliptinDRUGDoes not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet
Dapagliflozin 10 mgDRUGTablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
Matching Placebo for DapagliflozinDRUGMatching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
placeboDRUGmatching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
Metformin XRDRUGTablets, Oral, up to 2000 mg, once daily, 24 weeks
dapagliflozin matching PlaceboDRUGTablets
metformin HCl Modified Release matching PlaceboDRUGTablets
MetforminDRUGTablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
SitagliptinDRUGTablet oral 100 mg total daily dose once daily rescue medication
HydrochlorothiazideDRUGTablets, Oral, 25 mg, once daily, 12 weeks
2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tabletDRUGUsed in Treatment B and Treatment E.
2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tabletDRUGUsed in Treatment A and Treatment D.
5 mg dapagliflozin / 850 mg metformin XR FDCDRUGUsed in Treatment H.
5 mg dapagliflozin / 1000 mg metformin XR FDCDRUGUsed in Treatment G.
2.5 mg ONGLYZA® (saxagliptin) tabletDRUGUsed in treatments C and F.
5 mg Forxiga® (dapagliflozin) tabletDRUGUsed in treatments C, F and I.
500 mg Glucophage XR®DRUGUsed in treatments C, F and I.
Dapagliflozin + Glucophage tablet fastedDRUGSingle oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state
Dapagliflozin/metformin IR FDC tablet fastedDRUGsingle oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state
Dapagliflozin + Glucophage tablet fedDRUGSingle oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state
Dapagliflozin/metformin IR FDC tablet fedDRUGsingle oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state
WarfarinDRUGTablets, Oral, 25 mg, Single Dose
DigoxinDRUGTablets, Oral, 0.25, Single Dose
GlimepirideDRUGTablets, Oral, 4 mg, Single Dose
simvastatinDRUGTablets, Oral, 20 mg, Single Dose
valsartanDRUGTablets, Oral, 320 mg, Single Dose
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites110

Inclusion Criteria: 1. Patients aged ≥18 years old at time of informed consent; 2. Patients with Type 2 diabetes mellitus (T2DM) defined as HbA1C≥7.5% to ≤10.0% at screening visit; 3. Stable metformin therapy for at least 8 weeks prior to enrolment at a dose of ≥1500mg per day; 4. BMI ≤45.0kg/m2 at...

Countries:United StatesCanadaCzechiaGermanyMexicoRussiaBulgariaItalyPolandSpainSwedenSlovakiaArgentinaAustraliaAustriaChileHungaryRomaniaTaiwanVietnamIndiaPuerto RicoSouth KoreaSouth AfricaNetherlandsJapanUnited Kingdom
Unlock Eligibility Criteria