An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00094770

Purpose

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).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: MK0431, sitagliptin phosphate Drug: Comparator: glipizide	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Glipizide Metformin Metformin hydrochloride Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
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

Further study details as provided by Merck:

Primary Outcome Measures:

After 52 weeks, reduction in HbA1C. [ Time Frame: 52 weeks ]
Safety and tolerability.

Secondary Outcome 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 ]
After 104 weeks, reduction in HbA1C; durability of glycemic efficacy [ Time Frame: 104 weeks ]

Estimated Enrollment:	1000
Study Start Date:	October 2004

Detailed Description:

The duration of treatment is 104 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094770

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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.

Study ID Numbers:	2004_049
Study First Received:	October 22, 2004
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00094770
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glipizide
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009