Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
Summary
The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.
Timeline
- Start
- 2012-07
- Primary completion
- 2014-01
- Completion
- 2014-01
Outcome
Met primary endpoint
registry Arm 1: Saxagliptin+Metformin XR+Placebo vs Arm 3: Saxagliptin+Dapagliflozin+Metformin XR; p <0.0001; Mean Difference (Final Values) -0.59 (95% CI -0.81 to -0.37) NCT01606007 ↗
registry Arm 2: Dapagliflozin+Metformin XR+Placebo vs Arm 3: Saxagliptin+Dapagliflozin+Metformin XR; p = 0.0166; Mean Difference (Final Values) -0.27 (95% CI -0.48 to -0.05) NCT01606007 ↗
release “patients treated with saxagliptin/dapagliflozin plus metformin achieved significantly greater reductions in HbA1c versus either agent alone plus metformin” astrazeneca.com ↗
release “The study met its primary endpoint, with patients receiving the investigational triple combination of dapagliflozin 10 mg, saxagliptin 5 mg and metformin” astrazeneca.com ↗
Publications
- Results Rosenstock J, Hansen L, Zee P, Li Y, Cook W, Hirshberg B, Iqbal N. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015 Mar;38(3):376-83. doi: 10.2337/dc14-1142. Epub 2014 Oct 28.
- Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.
- Rosenstock J, Mathieu C, Chen H, Garcia-Sanchez R, Saraiva GL. Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin. Arch Endocrinol Metab. 2018 Aug;62(4):424-430. doi: 10.20945/2359-3997000000056.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Subject | SAXAGLIPTIN ANHYDROUS | Small molecule | 5 mg | Oral |
| Background | Metformin XR | Small molecule | 1500 mg | Oral |
| Background | Metformin XR | Small molecule | 2000 mg | Oral |