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

Sponsor:	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: sitagliptin (MK0431) Drug: Comparator: glipizide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glipizide Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline in HbA1c at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in HbA1c at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]
Change From Baseline in Body Weight at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
Change From Baseline in Body Weight at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: Yes ]
Hypoglycemic Events at Week 52 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
Hypoglycemic Events at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Number of Participants With Serious CAEs at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Number of Participants With Drug-related CAEs at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Number of Participants With Serious LAEs at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Number of Participants With Drug-related LAEs at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]

Enrollment:	1172
Study Start Date:	September 2004
Study Completion Date:	May 2007
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sitagliptin 100 mg: Experimental Sitagliptin 100 mg oral tablets of sitagliptin once daily.	Drug: sitagliptin (MK0431) Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Glipizide: Active Comparator Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.	Drug: Comparator: glipizide Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

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.

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_049, MK0431-024
Study First Received:	October 22, 2004
Results First Received:	September 24, 2009
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00094770 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Metabolic Diseases
Glipizide
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Pharmacologic Actions
Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010