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 — —