MedTrace Logo

Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

NCT00541775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2015-08-24

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

DRUG

Sitagliptin

Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.

DRUG

Comparator: Rosiglitazone

Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.

DRUG

Comparator: Placebo

placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.

DRUG

Comparator: Metformin

Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-03-31
Completion
2007-03-31

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00541775 on ClinicalTrials.gov