MK0767 in Type 2 Diabetes (0767-012)

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543556
• Other study ID #: 0767-012
• Secondary ID: 2007_640
• Status: Terminated
• Phase: Phase 2
• First received: October 5, 2007
• Last updated: June 12, 2015
• Start date: October 2001
• Est. completion date: November 2003

Study information

• Verified date: June 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

This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This study will also see how effective MK0767 is in lowering markers of glucose metabolism and improving the lipid profile and non-HDL cholesterol when compared with placebo and pioglitazone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 514
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes Mellitus patients between the ages of 21 and 75 inclusive

• Patient is willing to discontinue current therapy for the duration of the study

• Patient is not a heavy drinker

Exclusion Criteria:

• Patient has a history of Type 1 diabetes and/or ketoacidosis

• Patient has severe diabetic retinopathy, or nephropathy, or neuropath

• Patient has has anti-hyperglycemic therapy including insulin, or rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to visit 1

• Patient has a history of, allergy to, intolerance or hypersensitive to troglitazone, rosiglitazone, or pioglitazone including history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MK0767

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.