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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT01296412
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • sitagliptin — DRUG
    100 mg tablet, orally, once daily.
  • liraglutide — DRUG
    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.
  • glimepiride — DRUG
    starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.
  • metformin — DRUG
    metformin tablets at a dose of ≥1500 mg per day

Study Details

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.

Key Dates

Start date
Mar 11, 2011
Status verified
May 2017
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
653 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sitagliptin +/- glimepiride
    Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control.
  • Active Comparator: Liraglutide
    Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (A1C) [ Time Frame: Baseline and Week 26 ]

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