drugset / Trial / NCT00481663

A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

NCT00481663

Phase 2 Completed 555 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).

Timeline

Start
2003-08-19
Primary completion
2004-07-21
Completion
2006-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Sitagliptin Small molecule 25 mg
Subject Sitagliptin Small molecule 50 mg
Subject Sitagliptin Small molecule 100 mg
Comparator Metformin Small molecule 850 mg
Background Pioglitazone Small molecule 30 mg
Background Rosiglitazone Small molecule