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A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00792935
First received: November 14, 2008
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: MK-0941
Drug: Glimepiride
Drug: Metformin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.

  • Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: Yes ]
    Hypoglycemic episodes are defined as either a fingerstick glucose measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia.


Enrollment: 143
Study Start Date: January 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0941 Drug: MK-0941
MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.
Drug: Metformin
The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.
Active Comparator: Glimepiride Drug: Glimepiride
Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.
Other Name: Amaryl®
Drug: Metformin
The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Between the ages of 18 and 70

Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or ketoacidosis.
  • Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
  • Patient has had surgery within 30 days of starting the study or has planned major surgery during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792935

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00792935     History of Changes
Other Study ID Numbers: 0941-017, 2008_589
Study First Received: November 14, 2008
Results First Received: June 28, 2012
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013