drugset / Trial / NCT00399711
Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.
Timeline
- Start
- 2006-11
- Primary completion
- 2007-11
- Completion
- 2007-11
Outcome
Met primary endpoint
paper Thus, the predefined statistical criterion for non-inferiority was met. PMID 19476470 ↗
paper Repaglinide/metformin FDC BID was non-inferior to repaglinide/metformin FDC TID with respect to HbA1c. PMID 19531054 ↗
Publications
- Results Raskin P, Lewin A, Reinhardt R, Lyness W; Repaglinide/Metformin Fixed-Dose Combination Study Group. Twice-daily and three-times-daily dosing of a repaglinide/metformin fixed-dose combination tablet provide similar glycaemic control. Diabetes Obes Metab. 2009 Oct;11(10):947-52. doi: 10.1111/j.1463-1326.2009.01069.x. Epub 2009 Jun 16.
- Results Raskin P, Lewin A, Reinhardt R, Lyness W; Repaglinide/Metformin Fixed-Dose Combination Study Group. Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet. Diabetes Obes Metab. 2009 Sep;11(9):865-73. doi: 10.1111/j.1463-1326.2009.01062.x. Epub 2009 May 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | — | — |
| Subject | Repaglinide | Small molecule | — | — |
| Subject | Rosiglitazone | Small molecule | — | — |