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Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

NCT01296412 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 653

Last updated 2017-06-09

Study results available
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Summary

This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based

treatment.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

sitagliptin

100 mg tablet, orally, once daily.

DRUG

liraglutide

0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals.

DRUG

glimepiride

starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.

DRUG

metformin

metformin tablets at a dose of ≥1500 mg per day

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-03-11
Primary Completion
2012-02-29
Completion
2012-02-29

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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 NCT01296412 on ClinicalTrials.gov