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)

NCT01698775

Phase 3 Completed 213 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
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