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

Phase 2TerminatedNCT00479466

Merck Sharp & Dohme LLC342 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

342

Conditions

Diabetes Mellitus, Type 2

Interventions

MK0893DRUG

MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.

MetforminDRUG

Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.

Placebo to MK0893DRUG

Dose-matched placebo tablets to MK0893; taken orally once daily.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Week 12

Secondary Outcomes

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)

Time frame: Week 12

Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)

Time frame: Week 12

Data from ClinicalTrials.gov

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