Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543361
• Other study ID #: 0767-020
• Secondary ID: MK0767-0202007_6
• Status: Terminated
• Phase: Phase 3
• First received: October 5, 2007
• Last updated: June 11, 2015
• Start date: May 2003
• Est. completion date: December 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

The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 382
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 78 Years

Eligibility

Inclusion Criteria:

• Patients are men and non-pregnant women ages 21 to 78 years

• Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study

Exclusion Criteria:

• Patient has history of type 1 diabetes mellitus and or history of ketoacidosis

• Patients undergoing surgery within 30 days of Visit 1

• Patients taking Warfin or Warfin-like anticoagulants

• Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• MK0767
Duration of Treatment: 52 Weeks
• Comparator: placebo (unspecified)
Duration of Treatment: 52 Weeks
• Comparator: metformin
Duration of Treatment: 52 Weeks

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	This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.		over the course of 52 weeks	No
Secondary	MK0767 will be safe and well tolerated.		over the course of 52 weeks	Yes