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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: MK-0941
Drug: Comparator: Placebo
Biological: Lantus
Drug: Metformin
PhasePhase 2
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT00767000
First ReceivedOctober 3, 2008
Last UpdatedFebruary 27, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateOctober 3, 2008
Last Updated DateFebruary 27, 2014
Start DateOctober 2008
Estimated Primary Completion DateJune 2010
Current Primary Outcome Measures
  • Change in Hemoglobin A1c (HbA1c) Level [Time Frame: Baseline and Weeks 14, 54, 106, and 158] [Designated as safety issue: No]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] [Designated as safety issue: Yes]
  • Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event [Time Frame: Entire study including 54-week study and 104-week extension] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • Change in the Two-hour Post Meal Glucose Level [Time Frame: Baseline and Weeks 14, 54, 106, and 158] [Designated as safety issue: No]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] [Designated as safety issue: No]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] [Designated as safety issue: No]
  • 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] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleDose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Official TitleA 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 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.
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: MK-0941
MK-0941 tablets three times daily
Drug: Comparator: Placebo
Matching placebo to MK-0941 three times daily
Biological: Lantus
Lantus injection once daily
Other Names:
Insulin glargine injectionDrug: Metformin
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.
Study Arm (s)
  • Experimental: MK-0941 10 mg
  • Experimental: MK-0941 20 mg
  • Experimental: MK-0941 30 mg
  • Experimental: MK-0941 40 mg
  • Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment813
Estimated Completion DateJune 2010
Estimated Primary Completion DateApril 2010
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
GenderBoth
Ages21 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00767000
Other Study ID Numbers0941-007
Has Data Monitoring CommitteeNot Provided
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification DateFebruary 2014