MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

Merck Sharp & Dohme LLC517 enrolled

Overview

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

517

Conditions

Type 2 Diabetes Mellitus

Interventions

sitagliptin phosphate (+) metformin hydrochlorideDRUG

sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an \~32 wk treatment period

Comparator: pioglitazoneDRUG

pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

General Inclusion Criteria: * Patient has type 2 diabetes mellitus * Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy General Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or history of ketoacidosis * Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks * Patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

Outcomes

Primary Outcomes

Change From Baseline in A1C at Week 32

A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent

Time frame: Baseline and Week 32

Secondary Outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1

Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone

Time frame: Baseline and Week 1

Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32

Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG

Time frame: Baseline and Week 32

Change From Baseline in FPG at Week 32

Change from baseline reflects the Week 32 FPG minus the baseline FPG

Time frame: Baseline and Week 32

Percent of Participants With A1C <7.0% at Week 32

Time frame: Week 32

Data from ClinicalTrials.gov

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