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Clinical Trials/NCT00289848
NCT00289848
Completed
Phase 3

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Merck Sharp & Dohme LLC0 sites530 target enrollmentMarch 2006

Overview

Phase
Phase 3
Intervention
sitagliptin phosphate
Conditions
Type 2 Diabetes Mellitus
Sponsor
Merck Sharp & Dohme LLC
Enrollment
530
Primary Endpoint
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
March 2007
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

1

sitagliptin 100 mg

Intervention: sitagliptin phosphate

Outcomes

Primary Outcomes

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

Time Frame: Baseline and 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.

Secondary Outcomes

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18(Baseline and Week 18)
  • Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18(Baseline and Week 18)

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