CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
MK-0941 +1 moredrug
Likely dose
MK-0941 240 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00873821
NCT00873821Phase 1Completed
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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes

Merck Sharp & Dohme LLC·interventional·Posted Apr 2, 2009·Updated Mar 9, 2015

In Brief

A Phase 1 clinical trial evaluating MK-0941 and Comparator: Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 44 participants.

Detailed Summary

A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2009
Enrollment StartDec 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.3 years ago

Interventions

MK-0941drug

Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.

Comparator: Placebodrug

Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.