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Clinical Trials/NCT00541775
NCT00541775CompletedPhase 3

A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Merck Sharp & Dohme LLC0 sites273 target enrollmentStarted: June 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
273
Primary Endpoint
Hemoglobin A1C (A1C) at Week 18
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patient has Type 2 diabetes
  • •Currently taking metformin >1500 mg/day for at least 10 weeks
  • •Male or female

Exclusion Criteria

  • •Patient has peripheral edema
  • •History of type 1 diabetes
  • •Patient required insulin within prior 8 weeks
  • •Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
  • •Participating in a weight loss program

Arms & Interventions

Sitagliptin

Experimental

sitagliptin 100 mg

Intervention: Sitagliptin (Drug)

Outcomes

Primary Outcomes

Hemoglobin A1C (A1C) at Week 18

Time Frame: Baseline and 18 Weeks

A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo.

Secondary Outcomes

  • 2-hour Post-meal Glucose (PMG) at Week 18(Baseline and 18 Weeks)
  • Fasting Plasma Glucose (FPG) at Week 18(Baseline and 18 Weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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