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Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)

NCT01462266 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2018-08-17

Study results available
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Summary

The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with metformin. The primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of insulin relative to placebo.

Conditions

Interventions

DRUG

Sitagliptin

Sitagliptin 100 mg tablet once daily for 24 weeks

DRUG

Comparator: Placebo

Placebo to sitagliptin once daily for 24 weeks

BIOLOGICAL

Insulin Glargine

Participants on insulin glargine or another insulin regimen for at least 10 weeks prior to screening will continue or switch to open-label insulin glargine once-daily in the evening for the duration of the study.

DRUG

Metformin

Participants on metformin oral tablet(s) at a dose of at least 1500 mg/day for at least 10 weeks prior to screening will continue receiving metformin at their current dose for the duration of the study.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-13
Primary Completion
2013-06-06
Completion
2013-06-07

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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 NCT01462266 on ClinicalTrials.gov