drugset / Trial / NCT00660907
Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
Timeline
- Start
- 2008-03
- Primary completion
- 2009-12
- Completion
- 2013-01
Publications
- Results Nauck MA, Del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep;34(9):2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4.
- Nauck M, del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. [Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S6-15. doi: 10.1055/s-0032-1305283. Epub 2013 Mar 25. German.
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 |
| Comparator | Glipizide | Small molecule | 5 mg | Oral |
| Comparator | Glipizide | Small molecule | 10 mg | Oral |
| Comparator | Glipizide | Small molecule | 20 mg | Oral |
| Background | Metformin | Small molecule | 1500 mg | Oral |
| Background | Metformin | Small molecule | 2000 mg | Oral |
| Background | Metformin | Small molecule | 2500 mg | Oral |