drugset / Trial / NCT01698775
A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of omarigliptin in participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end stage renal disease on dialysis with inadequate glycemic control. The primary hypothesis of the study is that omarigliptin compared to placebo produces greater reduction in glycosylated hemoglobin (A1C) after 24 weeks.
Timeline
- Start
- 2012-10-02
- Primary completion
- 2016-01-19
- Completion
- 2016-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omarigliptin | Small molecule | 12.5 mg | Oral |
| Subject | Omarigliptin | Small molecule | 25 mg | Oral |
| Background | Glipizide | Small molecule | 2.5 mg | — |
| Background | Glipizide | Small molecule | 20 mg | — |
| Background | Insulin | Protein / enzyme biologic | — | — |