A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT02492763
Phase
PHASE2
Status
Terminated

Conditions

  • Type II Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MK-8521 — DRUG
    Dose strengths: 180 μg QD administered subcutaneously. A 2-step dose escalation regimen \[60 μg, 120 μg\] over the first 2 weeks is used to achieve the final dose up to 180 μg.); 300 μg QD administered subcutaneously (A 3-step dose escalation regimen \[60 μg, 120 μg, 180 μg\] over the first 3 weeks is used to achieve the final dose up to 300 μg.
  • Placebo — DRUG
    Double dummy matching placebo for the MK-8521 and placebo arms: matching placebo for MK-8521 300 μg QD administered subcutaneously; matching placebo for MK-8521 180 μg QD administered subcutaneously. A dose escalation regimen consistent with that of the MK-8521 300 μg and 180 μg arms of the study; mock escalation will be performed over the first 2 to 3 weeks.
  • Liraglutide — DRUG
    Dose strength: 1.8 mg QD administered subcutaneously. A 2-step dose escalation regimen (0.6 mg, 1.2 mg) over the first 2 weeks is used to achieve the final dose up to 1.8 mg.
  • Metformin — DRUG
    Metformin immediate release (IR) or metformin extended release (XR) administered ≥1000 mg QD as background therapy

Study Details

This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide; Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000 mg/day). The trial will include a 1-week screening period; at least an 8-week antihyperglycemic agent (AHA) washout period, if required; a 14-week blinded therapy period (which includes single-blind run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks after the last dose of investigational product. The primary hypothesis of the trial is that MK-8521 provides greater reduction in hemoglobin A1C relative to placebo after 12 weeks of once-daily administration in participants with T2DM with inadequate glycemic control on metformin monotherapy.

Key Dates

Start date
Jul 27, 2015
Status verified
Aug 2018
Primary completion
Apr 18, 2017
Completion
Apr 18, 2017

Study Design

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

Arms

  • Experimental: MK-8521 300 μg
    Participants receive double-blind MK-8521 300 μg daily (QD), subcutaneously, over 12 weeks.
  • Experimental: MK-8521 180 μg
    Participants receive double-blind MK-8521 180 μg QD, subcutaneously, over 12 weeks.
  • Placebo Comparator: Placebo
    Participants receive matching double-blind placebo, QD over 12 weeks.
  • Active Comparator: Liraglutide 1.8 mg
    Participants receive open-label 1.8 mg of liraglutide, QD, subcutaneously, over 12 weeks.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1C (A1C) at Week 12 [ Time Frame: Baseline and Week 12 ]

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