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

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

Official Title
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A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: MK-0941
* Drug: Placebo
* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has Type 2 Diabetes Mellitus 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants receiving placebo tablets three times daily plus insulin injection once daily | Drug: Placebo<br>* Placebo tablets, taken 3 times daily.<br>Drug: Insulin<br>* Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.<br>* Other names: LANTUS®;|
| Experimental: MK-0941<br>Participants receiving MK-0941 tablets three times daily plus insulin injection once daily | Drug: MK-0941<br>* MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.<br>Drug: Insulin<br>* Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.<br>* Other names: LANTUS®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) Level | 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. | Baseline (Day 1) and End of Treatment (Week 20) | 
| Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) | 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. | From first dose of study drug (Week 0) to last dose of study drug (Week 20) |