drugset / Trial / NCT00909597
A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes
RandomizedParallel-groupDouble-blindTreatment
Summary
This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.
Timeline
- Start
- 2009-05
- Primary completion
- 2010-11
- Completion
- 2010-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pioglitazone | Small molecule | 45 mg | Oral |
| Subject | taspoglutide | Peptide | 10 mg | Subcutaneous |
| Subject | taspoglutide | Peptide | 20 mg | Subcutaneous |