Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-0941
Comparator: Placebo
Lantus
Metformin
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MK-0941 10 mg
MK-0941 20 mg
MK-0941 30 mg
MK-0941 40 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Hemoglobin A1c (HbA1c) Level
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
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Secondary Outcome Measures
Change in the Two-hour Post Meal Glucose Level
Least squares mean change from baseline in 2-hour post meal glucose level.
Change in the Fasting Plasma Glucose Level
Least squares mean change from baseline in fasting plasma glucose.
Percentage of Participants Who Achieve an HbA1c of <7.0%
Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
Full Information
NCT ID
NCT00767000
First Posted
October 3, 2008
Last Updated
February 2, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00767000
Brief Title
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
813 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK-0941 10 mg
Arm Type
Experimental
Arm Title
MK-0941 20 mg
Arm Type
Experimental
Arm Title
MK-0941 30 mg
Arm Type
Experimental
Arm Title
MK-0941 40 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MK-0941
Intervention Description
MK-0941 tablets three times daily
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Matching placebo to MK-0941 three times daily
Intervention Type
Biological
Intervention Name(s)
Lantus
Other Intervention Name(s)
Insulin glargine injection
Intervention Description
Lantus injection once daily
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c (HbA1c) Level
Description
Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Time Frame
Baseline and Weeks 14, 54, 106, and 158
Title
Percentage of Participants Who Experienced at Least One Adverse Event
Time Frame
Entire study including 54-week study and 104-week extension
Title
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Time Frame
Entire study including 54-week study and 104-week extension
Secondary Outcome Measure Information:
Title
Change in the Two-hour Post Meal Glucose Level
Description
Least squares mean change from baseline in 2-hour post meal glucose level.
Time Frame
Baseline and Weeks 14, 54, 106, and 158
Title
Change in the Fasting Plasma Glucose Level
Description
Least squares mean change from baseline in fasting plasma glucose.
Time Frame
Baseline and Weeks 14, 54, 106, and 158
Title
Percentage of Participants Who Achieve an HbA1c of <7.0%
Time Frame
Weeks 106 and 158
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21994424
Citation
Meininger GE, Scott R, Alba M, Shentu Y, Luo E, Amin H, Davies MJ, Kaufman KD, Goldstein BJ. Effects of MK-0941, a novel glucokinase activator, on glycemic control in insulin-treated patients with type 2 diabetes. Diabetes Care. 2011 Dec;34(12):2560-6. doi: 10.2337/dc11-1200. Epub 2011 Oct 12.
Results Reference
result
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Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
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