drugset / Trial / NCT01183013
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.
Timeline
- Start
- 2010-08
- Primary completion
- 2013-02
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Linagliptin | Small molecule | 5 mg | Oral |
| Comparator | Pioglitazone | Small molecule | 30 mg | Oral |
| Comparator | Pioglitazone | Small molecule | 45 mg | Oral |