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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792935
• Other study ID #: 0941-017
• Secondary ID: 2008_589CTRI/200
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2008
• Last updated: December 16, 2015
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: December 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose	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.	Baseline and Week 6	No
Primary	Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)	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.	Baseline to Week 6	Yes