Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)

Phase 2

Terminated

Brief Summary: The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.

Detailed Description: This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.

Recruitment & Eligibility

Inclusion Criteria

has type 2 diabetes mellitus
has body mass index >20 and <43 kg/m^2
is a male, or a female who is unlikely to conceive
currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus

Extension Study Inclusion Criteria:

completed the base study either on double-blind study medication or as part of the post-treatment follow up population
had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period

Exclusion Criteria

has any history of Type 1 diabetes mellitus or ketoacidosis
has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
has undergone surgery within 30 days prior to Visit 1 or has planned major surgery

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c (HbA1c) Level	Baseline and Weeks 14, 54, 106, and 158	Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event	Entire study including 54-week study and 104-week extension
Percentage of Participants Who Experienced at Least One Adverse Event	Entire study including 54-week study and 104-week extension

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieve an HbA1c of <7.0%	Weeks 106 and 158
Change in the Two-hour Post Meal Glucose Level	Baseline and Weeks 14, 54, 106, and 158	Least squares mean change from baseline in 2-hour post meal glucose level.
Change in the Fasting Plasma Glucose Level	Baseline and Weeks 14, 54, 106, and 158	Least squares mean change from baseline in fasting plasma glucose.
Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%	Weeks 54, 106 and 158