An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: MK0431, sitagliptin phosphate (Drug); Comparator: glipizide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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).
Clinical Details
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
Study design: Treatment
Primary outcome: After 52 weeks, reduction in HbA1C.Safety and tolerability.
Secondary outcome: 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.After 104 weeks, reduction in HbA1C; durability of glycemic efficacy
Detailed description:
The duration of treatment is 104 weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: 78 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who are at least 18 years of age and not older than 78 with type 2 diabetes
mellitus
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: October 2004
Last updated: October 8, 2007
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