drugset / Trial / NCT00251940
GALLANT 7 Tesaglitazar Add-on to Sulphonylurea
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period
Timeline
- Start
- 2004-07
- Primary completion
- —
- Completion
- 2006-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tesaglitazar | Small molecule | 0.5 mg | — |
| Subject | Tesaglitazar | Small molecule | 1 mg | — |
| Background | Glyburide | Small molecule | 2.5 mg | — |
| Background | Glyburide | Small molecule | 5 mg | — |
| Background | Glyburide | Small molecule | 10 mg | — |
| Background | Glyburide | Small molecule | 15 mg | — |