Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Saxagliptin · 37 trials · 5 indications
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in HbA1c (%) at the end of 24 weeks of double-blinded treatment.
HbA1c was measured as percent of hemoglobin by a central laboratory. 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 at Week 24 in the double-blind period, including observations prior to rescue.
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.
Adjusted\* mean change from baseline in glycosylated haemoglobin A1c (HbA1c) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.
Mean change was adjusted for baseline.
Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load \[intravenous-oral hyperglycemic clamp (180-480 minutes)\] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Mean change from baseline is adjusted for baseline value.
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
To assess pharmacokinetics (PK) in terms of AUC in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers.
To assess PK in terms of AUC0-t in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers.
To assess PK in terms of Cmax in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers.
5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state
5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state
5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state
5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state
5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state
5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state
The geometric mean of the maximum observed plasma concentration (Cmax) is presented below; serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h,and 60 h postdose, relative to dosing on Day 1 in each cross over period and these data are summarized in the Pharmacokinetic (PK) parameter of Cmax presented here. Plasma samples were analyzed for dapagliflozin by High Performance Liquid chromatography-Mass Spectrometry (HPLC-MS/MS) using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Dapagliflozin Cmax was derived from plasma concentration versus time data using a non-compartmental method, using a validated PK analysis program ™. Actual sampling times were used for PK calculations. Cmax was reported in ng/mL.
AUC(INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. Serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(INF) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms\*hours per milliliter (ng\*h/mL).
AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method). Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(0-T) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms\*hours per milliliter (ng\*h/mL).
Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography-Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). Cmax for Saxagliptin was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in nanograms per milliliter (ng/mL).
Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography-Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(0-T), the area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms\*hours per milliliter (ng\*h/mL).
Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms\*hours per milliliter (ng\*h/mL).
AUC=Area under the concentration-time curve
AUC=Area Under the Concentration-time Curve
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
| Arm | Type | Description |
|---|---|---|
| Saxagliptin/Dapagliflozin/Metformin | EXPERIMENTAL | Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin |
| Insulin Glargine, Lantos/Metformin | ACTIVE_COMPARATOR | Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units. |
| Saxagliptin 5 mg + Metformin (500 mg with titration) | EXPERIMENTAL | Saxagliptin 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. |
| Saxagliptin 5 mg + Placebo | ACTIVE_COMPARATOR | Saxagliptin 5 mg once daily and Placebo 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. |
| Metformin (500 mg with titration) + Placebo | ACTIVE_COMPARATOR | Placebo 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. |
| A1:Saxagliptin / Placebo + Dapagliflozin / Placebo | EXPERIMENTAL | Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily) |
| A2: Sitagliptin / placebo | EXPERIMENTAL | Sitagliptin 100 mg and matching placebo 0 mg (once daily) |
| Saxagliptin 5mg | EXPERIMENTAL | Saxagliptin 5mg, administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin |
| Placebo | PLACEBO_COMPARATOR | Placebo administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin |
| Arm 1: Saxagliptin+Metformin XR+Placebo | ACTIVE_COMPARATOR | - |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | ACTIVE_COMPARATOR | - |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | EXPERIMENTAL | - |
| Arm 1: Saxagliptin+Dapagliflozin+Metformin IR | EXPERIMENTAL | - |
| Arm 2: Placebo+Dapagliflozin+Metformin IR | EXPERIMENTAL | - |
| Arm 1: Saxagliptin +Metformin XR/IR | EXPERIMENTAL | Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg |
| Arm 2: Placebo +Metformin XR/IR | PLACEBO_COMPARATOR | Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg |
| Saxagliptin | EXPERIMENTAL | Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) |
| Saxagliptin 5 mg once daily | EXPERIMENTAL | - |
| Placebo once daily | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Saxagliptin |
| 2 | ACTIVE_COMPARATOR | Metformin Extended Release |
| Saxagliptin + Metformin XR + matching Metformin XR placebo | EXPERIMENTAL | (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) |
| Metformin XR + Metformin XR + matching Saxagliptin placebo | ACTIVE_COMPARATOR | (Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo) |
| Saxagliptin plus metformin IR | ACTIVE_COMPARATOR | - |
| Placebo plus metformin IR | PLACEBO_COMPARATOR | - |
| Saxagliptin, 5 mg + insulin | EXPERIMENTAL | Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin |
| Placebo + insulin | PLACEBO_COMPARATOR | Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin |
| Saxagliptin 5 mg + Metformin | EXPERIMENTAL | - |
| Placebo + Metformin | PLACEBO_COMPARATOR | - |
| Saxa | EXPERIMENTAL | Saxagliptin |
| Saxagliptin (A) | EXPERIMENTAL | Metformin 500-1500 mg (open-label, as needed for rescue in LT) |
| Placebo (ST) / Metformin (LT) (B) | PLACEBO_COMPARATOR | Metformin 500-1500 mg (open-label, as needed for rescue in LT) |
| Saxagliptin plus open-label TZD (A) | EXPERIMENTAL | Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) |
| Saxagliptin plus open-label TZD (B) | EXPERIMENTAL | Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) |
| Placebo plus open-label TZD (C) | PLACEBO_COMPARATOR | Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) |
| Saxagliptin + Metformin (A) | EXPERIMENTAL | Pioglitazone 15-45 mg (as needed for rescue) |
| Saxagliptin + Metformin (B) | EXPERIMENTAL | Pioglitazone 15-45 mg (as needed for rescue) |
| Saxagliptin + Metformin (C) | EXPERIMENTAL | Pioglitazone 15-45 mg (as needed for rescue) |
| Placebo+ Metformin (D) | PLACEBO_COMPARATOR | Pioglitazone 15-45 mg (as needed for rescue) |
| Saxagliptin 2.5 mg (A) | EXPERIMENTAL | Metformin 500-2000 mg (as needed for rescue) |
| Saxagliptin 5 mg (B) | EXPERIMENTAL | Metformin 500-2000 mg (as needed for rescue) |
| Saxagliptin 10 mg (C) | EXPERIMENTAL | Metformin 500-2000 mg (as needed for rescue) |
| Placebo (D) | PLACEBO_COMPARATOR | Metformin 500-2000 mg (as needed for rescue) |
| Open-Label Treatment Cohort (Direct Enrollees) (E) | EXPERIMENTAL | Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue) |
| Saxagliptin (2.5 mg) | EXPERIMENTAL | - |
| Saxagliptin (5 mg) | EXPERIMENTAL | - |
| Saxagliptin (10 mg) | EXPERIMENTAL | - |
| Saxagliptin (20 mg) | EXPERIMENTAL | - |
| Saxagliptin (40 mg) | EXPERIMENTAL | - |
| Saxagliptin (100 mg) | EXPERIMENTAL | - |
| Cohort 1: Sequence 1 (ABC) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 1: Sequence 2 (ACB) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ACB: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 1: Sequence 3 (BAC) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 1: Sequence 4 (BCA) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 1: Sequence 5 (CAB) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 1: Sequence 6 (CBA) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. A= Reference product - 2.5mg ONGLYZA (2.5mg saxagliptin) and 5/1000mg XIGDUO XR (5 mg dapagliflozin / 1000mg Metformin XR) after food. B = Test product - Triple FCDP consisting of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR after food. C = Test product - Triple FCDP tablet consisting of 2.5mg saxagliptin / 5mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 2: Sequence 1 (DEF) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 2: Sequence 2 (DFE) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 2: Sequence 3 (EDF) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 2: Sequence 4 (EFD) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. |
| Cohort 2: Sequence 5 (FDE) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. |
| COhort 2: Sequence 6 (FED) | EXPERIMENTAL | Subjects were randomized to treatment sequence 1 ABC: On Day 1, each subjects will receive orally single-dose of the treatment assigned to that treatment period. D= Reference product - 5mg ONGLYZA (5mg saxagliptin) and 10/1000mg XIGDUO XR (10 mg dapagliflozin / 1000mg Metformin XR) after food. E = Test product - Triple FCDP consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR after food. F = Test product - Triple FCDP tablet consisting of 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR without food. |
| Treatment A | EXPERIMENTAL | Single oral dose of saxagliptin tablet coadministered with dapagliflozin tablet |
| Treatment B | EXPERIMENTAL | Single oral dose of FDC (fixed-dose combination) tablet |
| Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting | OTHER | Saxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods |
| Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fasting | OTHER | Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods |
| Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fed | OTHER | Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods |
| Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting | OTHER | Saxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods |
| Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fasting | OTHER | Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods |
| Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fed | OTHER | Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods |
| Lower dose | EXPERIMENTAL | co-administration of a single oral dose of a 5 mg saxagliptin tablet and a 500 mg metformin XR (Glucophage XR®) tablet vs. single FDC tablet consisting of 5 mg saxagliptin and 500 mg metformin XR (Kombiglyze XR) |
| Higher dose | EXPERIMENTAL | co-administration of a single oral dose of a 5 mg saxagliptin tablet and two (2) 500 mg metformin XR (Glucophage XR®) tablets vs. Single FDC tablet consisting of 5 mg saxagliptin and 1000 mg metformin XR (Kombiglyze XR) |
| A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin) | EXPERIMENTAL | Treatment A: Saxagliptin 5mg, Tablet, Oral; Single dose Treatment B: Dapagliflozin 10mg, Tablet, Oral; single dose Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; single dose |
| A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin | EXPERIMENTAL | Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose |
| B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin) | EXPERIMENTAL | Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose. Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose |
| B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin | EXPERIMENTAL | Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose |
| C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin | EXPERIMENTAL | Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose |
| C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin | EXPERIMENTAL | Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, Once daily, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose |
| Arm 1: Treatments A,B/B,A | EXPERIMENTAL | Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A). |
| Arm 2: Treatments C,D/D,C | EXPERIMENTAL | Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C). |
| Arm 3: Treatments E, F/F,E | EXPERIMENTAL | Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days. Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E). |
| Arm 4: Treatments G,H/H,G | EXPERIMENTAL | Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days. Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G). |
| Arm A (saxagliptin 2.5 mg + metformin 850 mg; Fasting) | OTHER | A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fasted condition. |
| Arm B (saxagliptin 2.5 mg + metformin 850 mg FDC; Fasting) | OTHER | A single oral dose of 2.5-mg saxagliptin/850-mg metformin fixed dose combination (FDC) administered in the fasted condition. |
| Arm C (saxagliptin 2.5 mg + metformin 850 mg; Fed) | OTHER | A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fed condition. |
| Arm D (saxagliptin 2.5 mg + metformin 850 mg FDC; Fed) | OTHER | A single oral dose of 2.5-mg saxagliptin/850-mg metformin FDC administered in the fed condition. |
| 5 mg saxagliptin + 2 Glucophage XR 500 mg tablet | EXPERIMENTAL | - |
| FDC tablet (5 mg saxa + 1000 mg metformin XR) (single dose) | EXPERIMENTAL | under fed state, single dose |
| FDC tablet (5 mg saxa + 1000 mg metformin XR) (4 days) | EXPERIMENTAL | under fed state, 4 days |
| 5 mg saxagliptin + a single 500 mg metformin XR tablet | EXPERIMENTAL | - |
| FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fed) | EXPERIMENTAL | under fed state |
| FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fasting) | EXPERIMENTAL | under fasted state |
| S+ M, (fasted)> S/M (fed)> S/M (fasted)>S+M (fed) | EXPERIMENTAL | Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M \[fasted\]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M \[fed\]) followed by S/M under fasting conditions (S/M \[fasted\]) followed by S + M under fed conditions (S + M \[fed\]) |
| S/M (fasted)> S+M (fasted)> S+M (fed)> S/M (fed) | EXPERIMENTAL | Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed) |
| S+M (fed)> S/M (fasted) >S/M (fed)> S+M (fasted) | EXPERIMENTAL | Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted) |
| S/M (fed)> S+M (fed)> S+M (fasted)> S/M (fasted) | EXPERIMENTAL | Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted) |
| Arm A | OTHER | Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions |
| Arm B | OTHER | Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions |
| Arm C | OTHER | Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal |
| Arm D | OTHER | Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal |
| Name | Type | Description |
|---|---|---|
| Saxagliptin, Onglyza | DRUG | Tablets, Oral, 5mg , Once daily, 24 weeks |
| Dapagliflozin, Farxiga | DRUG | Tablets, Oral, 10mg , Once daily, 24 weeks |
| Glargine insulin | DRUG | 100 Units/ml solution for injection in a prefilled SoloStar pen |
| Metformin | DRUG | Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks |
| Saxagliptin 5 mg | DRUG | Tablet, Oral, 5 mg, Once daily in the morning |
| Placebo 5 mg for Saxagliptin | DRUG | Tablet, Oral, 5 mg, Once daily in the morning |
| Placebo 500 mg for metformin (with titration) | DRUG | Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration. |
| Metformin 500 mg with titration | DRUG | Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration. |
| Saxagliptin | DRUG | administered orally once daily |
| Dapagliflozin | DRUG | administered orally once daily |
| Sitagliptin | DRUG | administered orally once daily |
| Placebo matching with Saxagliptin | DRUG | administered orally once daily |
| Placebo matching with Dapagliflozin | DRUG | administered orally once daily |
| Placebo matching with Sitagliptin | DRUG | administered orally once daily |
| Saxagliptin 5mg | DRUG | Saxagliptin 5mg (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue). |
| Placebo for Saxagliptin | DRUG | Placebo tablets (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue). |
| Metformin XR | DRUG | Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks |
| Metformin IR | DRUG | Tablets, Oral, ≥ 1500mg, Twice daily, Up to 52 weeks |
| Placebo (Saxagliptin) | DRUG | Tablets, Oral, Once daily, 1-16 weeks |
| Placebo (Metformin) | DRUG | Tablets, Oral, Once daily, 1-16 weeks |
| Metformin (Active Rescue) | DRUG | Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks |
| Placebo | DRUG | tablet once daily for 24 weeks to be taken orally |
| Placebo matching Metformin XR | DRUG | Tablets, Oral, 0 mg, once daily, 4 weeks |
| Placebo matching Saxagliptin | DRUG | Tablets, Oral, 0 mg, once daily, 4 weeks |
| Saxagliptin plus metformin IR | DRUG | Tablets, Oral, 2.5 mg, Twice daily, 12 weeks |
| Placebo plus metformin IR | DRUG | Tablets, Oral, Placebo, Twice daily, 12 weeks |
| Saxagliptin, 5 mg + insulin | DRUG | Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue) |
| Placebo + insulin | DRUG | Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin |
| Metformin (blinded) | DRUG | Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12) |
| Metformin (open-label) | DRUG | Tablets, Oral, 500-1500 mg, as needed (starting in LT) |
| pioglitazone | DRUG | Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) |
| rosiglitazone | DRUG | Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) |
| Saxagliptin + Metformin | DRUG | Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) |
| Placebo + Metformin | DRUG | Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT) |
| Placebo matching Metformin | DRUG | Tablets, Oral, 0 mg, daily (42 months LT) |
| 2.5 mg Saxagliptin tablet | DRUG | A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with Type 2 diabetes mellitus (T2DM). |
| 5 mg dapagliflozin / 1000 mg metformin XR tablet | DRUG | Dapagliflozin - An inhibitor of sodium-glucose co-transporter 2 (SGLT-2), reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. |
| Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR | DRUG | Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. |
| 5 mg saxagliptin | DRUG | A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. |
| 10 mg dapagliflozin / 1000 mg metformin XR tablet | DRUG | Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. |
| Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR | DRUG | Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM. Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization. |
| Saxagliptin/Dapagliflozin FDC | DRUG | - |
| Metformin XR 500 mg | DRUG | Metformin XR oral tablet 500 mg, single dose |
| Mertformin XR 2 x 500 mg | DRUG | Metformin XR oral tablet 2 x 500 mg, single dose |
| Komboglyze XR 5/500 mg | DRUG | oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose |
| Komboglyze XR 5/1000 mg | DRUG | oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose |
| Saxagliptin/metformin fixed-dose combination (FDC) | DRUG | Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day |
| Metformin extended-release (XR) | DRUG | Tablet, oral, 500 mg, once on Day 1 only, 1 day |
| Saxagliptin/Metformin FDC | DRUG | Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day |
| saxagliptin + metformin (FDC tablet) | DRUG | Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose |
| Glucophage XR | DRUG | Tablets, Oral, 500 mg, once daily, Single dose |
| saxagliptin + metformin XR (FDC tablet) | DRUG | Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days |
| Co-administration of Saxagliptin and Metformin IR, Fasted | DRUG | Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions |
| Saxagliptin/Metformin, Fasting | DRUG | Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions |
| Co-administration of Saxagliptin and Metformin IR, Fed | DRUG | Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions |
| Saxagliptin/Metformin, Fed | DRUG | Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions |
| Metformin IR (glucophage) | DRUG | Tablets, Oral, 1000 mg, Once Daily, 1 week |
| Saxagliptin + Metformin IR (FDC) | DRUG | Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * At least 18 years of age at screening * HbA1c ≥ 8% and ≤ 12% at screening * Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L) * Stable dose metformin ≥ 1500 mg per day with...
Saxagliptin is used for the treatment of Type 2 Diabetes Mellitus (T2DM). It is being studied in patients with Type 2 Diabetes who are not controlled with diet and exercise, as an add-on to metformin, and in triple therapy regimens. It is an investigational small molecule in Phase 3 clinical development.
Saxagliptin is a small molecule that targets DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades incretin hormones. By inhibiting DPP-4, Saxagliptin increases levels of active incretins, which help regulate blood glucose by enhancing insulin secretion and reducing glucagon release, thereby improving glycemic control in Type 2 Diabetes.
Saxagliptin is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of Saxagliptin in patients with Type 2 Diabetes Mellitus.
Saxagliptin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials are evaluating its use in Type 2 Diabetes, including as monotherapy, add-on to metformin, and in triple therapy combinations.
Saxagliptin has been studied in several clinical trials, including NCT00374907 (a Phase 3 study in subjects with Type 2 Diabetes not controlled with diet and exercise), NCT00666458 (a Phase 3 add-on to metformin comparison with sitagliptin), and NCT01619059 (a Phase 3 triple therapy study). All trials are completed.
Saxagliptin is also known as Onglyza. It is a DPP-4 inhibitor being developed by AstraZeneca for the treatment of Type 2 Diabetes Mellitus. The drug is currently in Phase 3 clinical trials and is not yet approved.