Study S000670

An Exploratory Phase 2, Randomised, Double-blind, Placebo-controlled, and Open-label Active Comparator Study to Evaluate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03555994
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 51
Start: 2018-05-31
Primary completion: 2021-04-14
Lead sponsor: MedImmune LLC
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:MEDI0382; DRUG:Placebo; DRUG:Liraglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2017-005081-22; NIH:2017

Registered primary outcomes

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) [Day -1 to Day 28]
Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B) [Day -1 to Day 36]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0005744	Cotadutide promotes glycogenolysis in people with overweight or obesity diagnosed with type 2 diabetes. Parker VER, Nature metabolism	2023	Randomized trial	PMID 38066113 DOI	cites ClinicalTrials.gov:NCT03555994; registry reference DERIVED:38066113