MedTrace Logo

A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

NCT01590771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2018-08-17

Study results available
· View outcomes & findings →

Summary

A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.

Conditions

Interventions

DRUG

Sitagliptin

Sitagliptin 100 mg oral tablet once daily for 24 weeks

DRUG

Placebo

Matching placebo to sitagliptin oral tablet once daily for 24 weeks

DRUG

Gliclazide

Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.

DRUG

Glimepiride

Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.

DRUG

Metformin

Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-09
Primary Completion
2014-06-10
Completion
2014-06-24

More Related Trials

Entities

Drugs
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 NCT01590771 on ClinicalTrials.gov