A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: MK-0941; Drug: Insulin

• Registration Number: NCT00824616
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-19
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2012-07-17
• Results First Submitted QC: 2012-07-17
• Results First Posted: 2012-08-21
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Participant has Type 2 Diabetes Mellitus

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Exclusion Criteria

• Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis
• Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
• Participant has had surgery within 30 days of starting the study or has planned major surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receiving placebo tablets three times daily plus insulin injection once daily
MK-0941	Insulin	Participants receiving MK-0941 tablets three times daily plus insulin injection once daily
Placebo	Insulin	Participants receiving placebo tablets three times daily plus insulin injection once daily
MK-0941	MK-0941	Participants receiving MK-0941 tablets three times daily plus insulin injection once daily

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)	From first dose of study drug (Week 0) to last dose of study drug (Week 20)	Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.
Change From Baseline in Hemoglobin A1c (HbA1c) Level	Baseline (Day 1) and End of Treatment (Week 20)	HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.