The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes)...
Date First Received: October 22, 2004
Last Updated: October 8, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 3 | Start Date: October 2004
Overall Status: Completed
Estimated Enrollment: 1000
Brief Summary
Official Title: “A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy”
Condition Keyword(s):
Intervention(s):
The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
Study Type: Interventional
Study Design: Treatment
Detailed Clinical Trial Description
The duration of treatment is 104 weeks.
Intervention(s) in this Clinical Trial
- Drug: MK0431, sitagliptin phosphate
- Drug: Comparator: glipizide
Outcome Measures for this Clinical Trial
Primary Measures
- After 52 weeks, reduction in HbA1C.
- Time Frame: 52 weeks
- Time Frame: 52 weeks
- Safety and tolerability.
Secondary Measures
- After 52 and 104 weeks, reduction in fasting plasma glucose; incidence of hypoglycemic events; body weight; insulin secretion derived from the C-peptide, insulin, and glucose profile after a meal challenge.
- Time Frame: 52 weeks
- Time Frame: 52 weeks
- After 104 weeks, reduction in HbA1C; durability of glycemic efficacy
- Time Frame: 104 weeks
- Time Frame: 104 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 78 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00094770
Study ID Number: 2004_049
ClinicalTrials.gov Identifier: NCT00094770
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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