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A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

NCT00701090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1035

Last updated 2017-03-10

Study results available
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Summary

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Conditions

  • Type 2 Diabetes Mellitus, Non Insulin Dependent
  • Diabetes Mellitus, Non-Insulin-Dependent

Interventions

DRUG

sitagliptin

Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks

DRUG

Comparator: glimepiride

glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.

DRUG

open-label metformin

open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

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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 NCT00701090 on ClinicalTrials.gov