MedTrace Logo

Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

NCT00875394 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-05-30

Study results available
· View outcomes & findings →

Summary

After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Conditions

  • Diabetes Mellitus, Non-Insulin-Dependent

Interventions

DRUG

sitagliptin phosphate

sitagliptin 100 mg Once a day (QD) for 24 weeks

DRUG

Comparator: metformin

metformin 850 mg Twice a day (BID) for 24 weeks

DRUG

Comparator: metformin

metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks

DRUG

Comparator: Antidiabetic Standard of Care

Patient can take any oral antidiabetic drug (other than metformin)

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-01
Primary Completion
2008-06-27
Completion
2008-06-27

More Related Trials

Entities

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 NCT00875394 on ClinicalTrials.gov