A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Merck Sharp & Dohme LLC0 sites1,172 target enrollmentSeptember 2004

ConditionsDiabetes Mellitus, Type 2

Interventionssitagliptin (MK0431)

Overview

Phase: Phase 3
Intervention: sitagliptin (MK0431)
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 1172
Primary Endpoint: Change From Baseline in HbA1c at Week 52
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

Detailed Description

The duration of treatment is 104 weeks.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

May 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus

Exclusion Criteria

Not provided

Arms & Interventions

Sitagliptin 100 mg

Sitagliptin 100 mg oral tablets of sitagliptin once daily.

Intervention: sitagliptin (MK0431)

Outcomes

Primary Outcomes

Change From Baseline in HbA1c at Week 52

Time Frame: Baseline and Week 52

HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.

Secondary Outcomes

Change From Baseline in HbA1c at Week 104(Baseline and Week 104)
Hypoglycemic Events at Week 52(Baseline to Week 52)
Number of Participants With Serious CAEs at Week 104(Baseline to Week 104)
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104(Baseline to Week 104)
Change From Baseline in Body Weight at Week 52(Baseline and Week 52)
Change From Baseline in Body Weight at Week 104(Baseline and Week 104)
Number of Participants With Serious LAEs at Week 104(Baseline to Week 104)
Number of Participants With Drug-related LAEs at Week 104(Baseline to Week 104)
Hypoglycemic Events at Week 104(Baseline to Week 104)
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104(Baseline to Week 104)
Number of Participants With Drug-related CAEs at Week 104(Baseline to Week 104)