Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Saxagliptin/Metformin · 5 trials · 1 indication
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Cmax=Maximum observed plasma concentration CI=Confidence interval FDC=Fixed dosed combination XR=Extended release
AUC(0-T)=Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
AUC(INF)=Area under the plasma concentration-time curve from time zero extrapolated to infinity
| Arm | Type | Description |
|---|---|---|
| Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo | EXPERIMENTAL | Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally |
| Glimepiride or Placebo | EXPERIMENTAL | Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally |
| Saxagliptin 2.5 mg QAM (A) | EXPERIMENTAL | PLUS open-label metformin (as needed as rescue medication) |
| Saxagliptin 2.5 mg titrated to 5 mg QAM (B) | EXPERIMENTAL | PLUS open-label metformin (as needed as rescue medication) |
| Saxagliptin 5 mg QAM (C) | EXPERIMENTAL | PLUS open-label metformin (as needed as rescue medication) |
| Saxagliptin 5 mg QPM (D) | EXPERIMENTAL | PLUS open-label metformin (as needed as rescue medication) |
| Placebo (E) | PLACEBO_COMPARATOR | PLUS open-label metformin (as needed as rescue medication) |
| Saxagliptin and Metformin (A) | EXPERIMENTAL | PLUS open-label pioglitazone (as needed as rescue medication) |
| Saxagliptin and Metformin (B) | EXPERIMENTAL | PLUS open-label pioglitazone (as needed as rescue medication) |
| Saxagliptin and Placebo (C) | EXPERIMENTAL | PLUS open-label pioglitazone (as needed as rescue medication) |
| Metformin and Placebo (D) | ACTIVE_COMPARATOR | PLUS open-label pioglitazone (as needed as rescue medication) |
| Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) | EXPERIMENTAL | Metformin 500-2500 mg (as needed) |
| Saxagliptin 5 mg + Glyburide 7.5 mg (B) | EXPERIMENTAL | Metformin 500-2500 mg (as needed) |
| Placebo + Glyburide 7.5 mg (C) | PLACEBO_COMPARATOR | Metformin 500-2500 mg (as needed) |
| Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao) | EXPERIMENTAL | Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2 |
| Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon) | EXPERIMENTAL | Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2 |
| Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao) | EXPERIMENTAL | Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2 |
| Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon) | EXPERIMENTAL | Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2 |
| Name | Type | Description |
|---|---|---|
| Saxagliptin | DRUG | - |
| Dapagliflozin | DRUG | - |
| Glimepiride | DRUG | - |
| Placebo | OTHER | - |
| metformin | DRUG | Tablets, Oral, 500-2000 mg, as needed (12 months LT) |
| pioglitazone | DRUG | Tablets, Oral, 15-45 mg, as needed (12 months LT) |
| Glyburide | DRUG | Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) |
| Saxagliptin/Metformin | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects must be willing and able to give signed and dated written informed consent * Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control * Subject...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
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.