MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Merck Sharp & Dohme LLC1,246 enrolled

Overview

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,246

Conditions

Type 2 Diabetes Mellitus

Interventions

sitagliptin phosphate (+) metformin hydrochlorideDRUG

sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.

metforminDRUG

metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has type 2 diabetes mellitus * Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent * Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy * Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months * Patient is a male, or a female who is unlikely to conceive Exclusion Criteria: * Patient has type 1 diabetes mellitus or history of ketoacidosis

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1c (A1C) at Week 18

A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Time frame: Baseline and Week 18

Secondary Outcomes

Number of Patients With A1C < 7.0% at Week 18

Time frame: Week 18

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18

FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.

Time frame: Baseline and Week 18

Data from ClinicalTrials.gov

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