A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)(COMPLETED) | RxWiki

A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)(COMPLETED)

Overview[ - collapse ][ - ]

Purpose	This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: MK-0893 Drug: Sitagliptin Drug: Metformin Drug: Placebo for MK-0893 Drug: Placebo for Sitagliptin Drug: Placebo for Metformin
Phase	Phase 2
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00631488
First Received	February 21, 2008
Last Updated	January 14, 2012
Last verified	January 2012

Tracking Information[ + expand ][ + ]

First Received Date	February 21, 2008
Last Updated Date	January 14, 2012
Start Date	February 2008
Estimated Primary Completion Date	January 2009
Current Primary Outcome Measures	Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels [Time Frame: BL, 4 weeks (end of double-blind treatment period)] [Designated as safety issue: No]
Current Secondary Outcome Measures	Change From BL to Week 4 in Fasting Plasma Glucose (FPG) [Time Frame: BL, 4 weeks (end of double-blind treatment period)] [Designated as safety issue: No] Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC) [Time Frame: BL, 4 weeks (end of double-blind treatment period)] [Designated as safety issue: No] Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC [Time Frame: BL, 4 weeks (end of double-blind treatment period)] [Designated as safety issue: No]Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal. Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC [Time Frame: BL, 4 weeks (end of double-blind treatment period)] [Designated as safety issue: No]GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.

Descriptive Information[ + expand ][ + ]

Brief Title	A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)(COMPLETED)
Official Title	A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Brief Summary	This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
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 2
Intervention	Drug: MK-0893 Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks). Drug: Sitagliptin Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). Other Names: Sitagliptin JANUVIA™ MK0431 Drug: Metformin Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks). Other Names: Metformin GLUCOPHAGE® Drug: Placebo for MK-0893 Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period. Drug: Placebo for Sitagliptin Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). Drug: Placebo for Metformin Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).
Study Arm (s)	Experimental: MK-0893 + Sitagliptin Experimental: MK-0893 + Metformin Active Comparator: Sitagliptin + Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	146
Estimated Completion Date	January 2009
Estimated Primary Completion Date	January 2009
Eligibility Criteria	Inclusion Criteria: - Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy Exclusion Criteria: - Participants have a history of Type 1 Diabetes Mellitus - Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists) - Participants who have a contraindication to metformin or sitagliptin
Gender	Both
Ages	21 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00631488
Other Study ID Numbers	MK-0893-015
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	January 2012