Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02419612 | A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone | PHASE3 | COMPLETED | 444 | — | — | Aug 14, 2015 | Sep 18, 2019 | Jun 23, 2020 | 84 | United States, Czechia +8 |
| NCT00316082 | Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise | PHASE3 | COMPLETED | 365 | — | — | Jun 1, 2006 | Nov 1, 2008 | Apr 29, 2015 | 74 | United States, India +2 |
| NCT00327015 | A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise | PHASE3 | COMPLETED | 1,306 | — | — | May 1, 2006 | Dec 1, 2008 | Apr 29, 2015 | 211 | United States, Argentina +11 |
| NCT00313313 | A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas | PHASE3 | COMPLETED | 768 | — | — | Apr 1, 2006 | Sep 1, 2008 | May 4, 2015 | 115 | United States, Argentina +11 |
| NCT01874080 | Bioequivalence Study | PHASE1 | COMPLETED | 56 | — | — | Jun 1, 2013 | Jul 1, 2013 | Apr 23, 2015 | 1 | United States |
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...