Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
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
2 other identifiers
interventional
813
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Oct 2008
Typical duration for phase_2 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
September 3, 2012
CompletedFebruary 19, 2015
February 1, 2015
1.5 years
October 3, 2008
June 19, 2012
February 2, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Experienced at Least One Adverse Event
Entire study including 54-week study and 104-week extension
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Entire study including 54-week study and 104-week extension
Secondary Outcomes (4)
Change in the Two-hour Post Meal Glucose Level
Baseline and Weeks 14, 54, 106, and 158
Change in the Fasting Plasma Glucose Level
Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Achieve an HbA1c of <7.0%
Weeks 106 and 158
Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
Weeks 54, 106 and 158
Study Arms (5)
MK-0941 10 mg
EXPERIMENTALMK-0941 20 mg
EXPERIMENTALMK-0941 30 mg
EXPERIMENTALMK-0941 40 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Lantus injection once daily
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 21994424RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 6, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2010
Study Completion
June 1, 2010
Last Updated
February 19, 2015
Results First Posted
September 3, 2012
Record last verified: 2015-02