drugset / Trial / NCT01087502
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
Timeline
- Start
- 2010-03
- Primary completion
- 2012-05
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | — | — |
| Subject | Linagliptin | Small molecule | 5 mg | Oral |