Dose-Range Finding Study for MK0893 (0893-008)

Phase 2

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: MK0893; Drug: Metformin; Drug: Placebo to MK0893; Drug: Placebo to Metformin

• Registration Number: NCT00479466
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-25
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Study Start: 2007-07
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2011-10-07
• Results First Submitted QC: 2011-10-07
• Results First Posted: 2011-11-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

• Patients 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

• Patients have a history of Type 1 Diabetes Mellitus
• Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor [PPAR]-gamma agonist)
• Patients who have a contraindication to metformin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK0893 80 mg	MK0893	MK0893 tablets totaling 80 mg once daily.
MK0893 80 mg	Placebo to MK0893	MK0893 tablets totaling 80 mg once daily.
MK0893 80 mg	Placebo to Metformin	MK0893 tablets totaling 80 mg once daily.
MK0893 60 mg	MK0893	MK0893 tablets totaling 60 mg once daily.
MK0893 60 mg	Placebo to MK0893	MK0893 tablets totaling 60 mg once daily.
MK0893 60 mg	Placebo to Metformin	MK0893 tablets totaling 60 mg once daily.
MK0893 40 mg	MK0893	MK0893 40 mg tablet once daily.
MK0893 40 mg	Placebo to MK0893	MK0893 40 mg tablet once daily.
MK0893 20 mg	MK0893	MK0893 20 mg tablet once daily.
MK0893 20 mg	Placebo to MK0893	MK0893 20 mg tablet once daily.
MK0893 20 mg	Placebo to Metformin	MK0893 20 mg tablet once daily.
Metformin	Placebo to MK0893	Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.
Placebo	Placebo to MK0893	PLA tablets. 12 week treatment period.
Placebo	Placebo to Metformin	PLA tablets. 12 week treatment period.
MK0893 40 mg	Placebo to Metformin	MK0893 40 mg tablet once daily.
Metformin	Metformin	Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)	Week 12

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)	Week 12
Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)	Week 12