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

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

Overview[ - collapse ][ - ]

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	Type 2 Diabetes Mellitus
Intervention	Drug: MK-0941 Drug: Glimepiride Drug: Metformin
Phase	Phase 2
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00792935
First Received	November 14, 2008
Last Updated	August 31, 2012
Last verified	August 2012

Tracking Information[ + expand ][ + ]

First Received Date	November 14, 2008
Last Updated Date	August 31, 2012
Start Date	January 2009
Estimated Primary Completion Date	February 2010
Current 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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)(COMPLETED)
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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	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: 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 Names: 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.
Study Arm (s)	Experimental: MK-0941 Active Comparator: Glimepiride

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	143
Estimated Completion Date	February 2010
Estimated Primary Completion Date	February 2010
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00792935
Other Study ID Numbers	0941-017
Has Data Monitoring Committee	Not Provided
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification Date	August 2012