MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

Merck Sharp & Dohme LLC530 enrolled

Overview

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

530

Conditions

Type 2 Diabetes Mellitus

Interventions

sitagliptin phosphateDRUG

Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.

Comparator: placeboDRUG

placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) \>=7.5% and \<=11% and a Fasting Plasma Glucose (FPG) \>=130 mg/dL and \<=280 mg/dL Exclusion Criteria : * Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18

A1C was measured as a 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

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

Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.

Time frame: Baseline and Week 18

Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18

Change from baseline at Week 18 is defined as Week 18 minus Week 0.

Time frame: Baseline and Week 18

Data from ClinicalTrials.gov

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