Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED) | RxWiki

Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Condition	Diabetes Mellitus, Type II
Intervention	Drug: Sitagliptin (MK0431) Drug: Placebo/Glipizide 5 mg Drug: Metformin Drug: Pioglitazone
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00086515
First Received	July 2, 2004
Last Updated	November 19, 2010
Last verified	November 2010

Tracking Information[ + expand ][ + ]

First Received Date	July 2, 2004
Last Updated Date	November 19, 2010
Start Date	July 2004
Estimated Primary Completion Date	February 2007
Current Primary Outcome Measures	Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Current Secondary Outcome Measures	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]Change from baseline at Week 24 is defined as FPG at Week 24 minus FPG at Week 0. Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
Official Title	A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
Brief Summary	The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type II
Intervention	Drug: Sitagliptin (MK0431) Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104 Other Names: MK0431 sitagliptin phosphate Januvia Drug: Placebo/Glipizide 5 mg Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104) Drug: Metformin Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104) Other Names: MetforminDrug: Pioglitazone Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24) Other Names: Pioglitazone ACTOS
Study Arm (s)	Experimental: Sitagliptin 100 mg The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo. Placebo Comparator: Placebo / Glipizide 5 mg The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	701
Estimated Completion Date	February 2007
Estimated Primary Completion Date	February 2007
Eligibility Criteria	Inclusion Criteria: - Patients with type 2 diabetes mellitus
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00086515
Other Study ID Numbers	2006_411
Has Data Monitoring Committee	Not Provided
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification Date	November 2010