A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

Merck Sharp & Dohme LLC319 enrolled

Overview

The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

319

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

sitagliptin phosphateDRUG

sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks

Comparator: vogliboseDRUG

voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients have type 2 diabetes mellitus on diet/exercise therapy Exclusion Criteria: * Patients have type 1 diabetes mellitus

Outcomes

Primary Outcomes

Change From Baseline in HbA1c at Week 12

HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.

Time frame: Baseline and Week 12

Secondary Outcomes

Change From Baseline in Fasting Plasma Glucose at Week 12

Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.

Time frame: Baseline and Week 12

Change From Baseline in 2 Hour Postprandial Glucose at Week 12

Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.

Time frame: Baseline and Week 12

Data from ClinicalTrials.gov

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