An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Summary
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied
Timeline
- Start
- 2008-06
- Primary completion
- 2009-08
- Completion
- 2009-08
Outcome
Met primary endpoint
paper In both trials, combination therapy led to significantly greater reductions in HbA1c compared with either monotherapy: PMID 22413962 ↗
registry Dapagliflozin 5 mg + Metformin XR vs Dapagliflozin 5 mg; p <0.0001; Mean Difference (Final Values) -0.86 (95% CI -1.11 to -0.62) NCT00643851 ↗
registry Dapagliflozin 5 mg + Metformin XR vs Metformin XR; p <0.0001; Mean Difference (Final Values) -0.70 (95% CI -0.94 to -0.45) NCT00643851 ↗
Publications
- Results Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012 May;66(5):446-56. doi: 10.1111/j.1742-1241.2012.02911.x. Epub 2012 Mar 13.
- Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 5 mg | Oral |
| Subject | Metformin | Small molecule | 2000 mg | Oral |