Placebo Controlled Metformin and Sulfonylurea Combination Study in Patients With Type 2 Diabetes (0767-025)

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543751
• Other study ID #: 0767-025
• Secondary ID: 2007_634MK-0767-
• Status: Terminated
• Phase: Phase 3
• First received: October 5, 2007
• Last updated: June 16, 2015
• Start date: January 2003
• 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

The purpose of this study is to compare how MK0767 and metformin and sulfonylurea therapy lower blood glucose in patients with inadequate glycemic control This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 610
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 78 Years

Eligibility

Inclusion Criteria:

• Patients with Type 2 diabetes wtih inadequate glycemic control on maximally effective/tolerated metformin and sulfonylurea therapy

• Non-pregnant females

Exclusion Criteria:

• Patients with Type 1 Diabetes or history of ketoacidosis

• Patients who have been treated with insulin or other antihyperglycemic agents

• Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease

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

Intervention

Drug:
• MK0767

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.