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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

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 Summary: 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.
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Change in Hemoglobin A1c (HbA1c) Level [ Time Frame: 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 Experienced at Least One Adverse Event [ Time Frame: Entire study including 54-week study and 104-week extension ]
  • Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event [ Time Frame: Entire study including 54-week study and 104-week extension ]


Original Primary Outcome: HbA1c reduction compared to placebo when MK0941 is added to basal insulin [ Time Frame: 14 weeks ]

Current Secondary Outcome:

  • Change in the Two-hour Post Meal Glucose Level [ Time Frame: 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 [ Time Frame: Baseline and Weeks 14, 54, 106, and 158 ]
    Least squares mean change from baseline in fasting plasma glucose.
  • Percentage of Participants Who Achieve an HbA1c of <7.0% [ Time Frame: Weeks 106 and 158 ]
  • Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0% [ Time Frame: Weeks 54, 106 and 158 ]


Original Secondary Outcome: Effect on 2-hour post meal glucose level compared to placebo when MK0941 is added to basal insulin [ Time Frame: 14 weeks ]

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: October 3, 2008
Date Started: October 2008
Date Completion:
Last Updated: February 2, 2015
Last Verified: February 2015