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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)

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ClinicalTrials.gov Identifier: NCT00792935
Recruitment Status : Completed
First Posted : November 18, 2008
Results First Posted : October 3, 2012
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: MK-0941 Drug: Glimepiride Drug: Metformin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose [ Time Frame: Baseline and Week 6 ]
    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.

  2. Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) [ Time Frame: Baseline to Week 6 ]

    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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792935


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00792935     History of Changes
Other Study ID Numbers: 0941-017
2008_589
CTRI/2009/091/000154 ( Registry Identifier: CTRI )
First Posted: November 18, 2008    Key Record Dates
Results First Posted: October 3, 2012
Last Update Posted: December 17, 2015
Last Verified: December 2015

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
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors