Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT01982630
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once daily compared to placebo and another diabetes drug in participants with Type 2 diabetes mellitus (T2DM). This study was modified by a protocol amendment to a 2-part trial to further test the safety and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between participants with T2DM and healthy participants. An additional cohort of T2DM participants and a cohort of non-diabetic obese participants has been added.

Key Dates

Start date
Nov 7, 2013
Status verified
Dec 2021
Primary completion
Oct 3, 2014
Completion
Oct 3, 2014

Study Design

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

Arms

  • Experimental: Part 1: MK-8521 64/120 μg/day
    Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 starting at 64 μg on Days 1 to 7 and escalated to 120 μg on Days 8 to 14.
  • Experimental: Part 1: MK-8521 34/72 μg/day
    T2DM participants received once daily subcutaneous MK-8521 starting at 34 μg on Days 1 to 7 and escalated to 72 μg on Days 8 to 14.
  • Active Comparator: Part 1: Liraglutide 0.6/1.2/1.8 mg/day
    T2DM participants received once daily subcutaneous liraglutide starting at 0.6 mg on Day 1 and 2, escalated to 1.2 mg on Days 3 to 7, and escalated to 1.8 mg on Days 8 to 14.
  • Placebo Comparator: Part 1: Placebo for MK-8521
    T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
  • Experimental: Part 2: MK-8521 64/120/180/240/300 µg/day-T2DM
    T2DM participants received once daily subcutaneous MK-8521 titrated to 300 µg starting at 64 µg and increasing to 120 µg on Day 8, 180 µg on Day 15, 240 µg on Day 20, and 300 µg on Day 25. The total number of dosing days was 29.
  • Active Comparator: Part 2: Liraglutide 0.6/1.2/1.8 mg/day-T2DM
    T2DM participants received once daily subcutaneous liraglutide titrated to 1.8 mg starting at 0.6 mg and increasing to 1.2 mg on Day 8, and 1.8 mg on Day 15. The total number of dosing days was 29.
  • Placebo Comparator: Part 2: Placebo for MK-8521-T2DM
    T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
  • Experimental: Part 2: MK-8521 64/120 µg/day-Non-Diabetic Overweight/Obese
    Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 µg starting at 64 µg and increasing to 120 µg on Day 8. The total number of dosing days was 14.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events (AEs) in Part 1 [ Time Frame: Up to approximately 42 days ]

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