drugset / Trial / NCT00680745
Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.
Timeline
- Start
- 2008-04
- Primary completion
- 2009-11
- Completion
- 2010-05
Publications
- Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
- Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German.
- Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 2.5 mg | Oral |
| Subject | Dapagliflozin | Small molecule | 5 mg | Oral |
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Background | Glimepiride | Small molecule | 2.5 mg | Oral |
| Background | Glimepiride | Small molecule | 5 mg | Oral |
| Background | Glimepiride | Small molecule | 10 mg | Oral |
| Background | Metformin | Small molecule | — | Oral |
| Background | Pioglitazone | Small molecule | — | Oral |
| Background | Rosiglitazone | Small molecule | — | Oral |