Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Merck Sharp & Dohme LLC80 enrolled

Overview

A 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

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

sitagliptin phosphateDRUG

100 mg once daily (QD), taken orally for 4 weeks

Comparator: PlaceboDRUG

Placebo tablet, QD, taken orally for 4 weeks

Comparator: SitagliptinDRUG

50 mg twice daily (BID), taken orally for 4 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 69 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 24-hour Weighted Mean Plasma Glucose

Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.

Time frame: Baseline and Week 4

Secondary Outcomes

Change From Baseline in Plasma Glucose

Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.

Time frame: Baseline and Week 4

Data from ClinicalTrials.gov

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