A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.

Sponsor
MedImmune LLC
Study ID
NCT03555994
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI0382 — DRUG
    MEDI0382 administered subcutaneously
  • Placebo — DRUG
    Placebo administered subcutaneously
  • Liraglutide — DRUG
    Liraglutide administered subcutaneously

Study Details

A phase 2 study in two parts (A \& B) designed to evaluate the effect of MEDI0382 on Hepatic Glycogen Metabolism in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately 20 subjects will be enrolled in Part A and approximately 30 subjects in Part B.

Key Dates

Start date
May 31, 2018
Status verified
Sep 2024
Primary completion
Apr 14, 2021
Completion
Apr 14, 2021

Study Design

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

Arms

  • Experimental: MEDI0382 (Part A)
    MEDI0382 administered subcutaneously (Part A)
  • Placebo Comparator: Placebo (Part A)
    Placebo comparator administered subcutaneously (Part A)
  • Active Comparator: Liraglutide (Part B)
    Active comparator administered subcutaneously (Part B)
  • Experimental: MEDI0382 (Part B)
    MEDI0382 administered subcutaneously (Part B)
  • Placebo Comparator: Placebo (Part B)
    Placebo comparator administered subcutaneously (Part B)

Primary Outcome Measure

Change in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only) [ Time Frame: Day -1 to Day 28 ]

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