Study S000151

A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Different Doses of MEDI0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03244800
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 65
Start: 2017-09-04
Primary completion: 2018-01-23
Lead sponsor: MedImmune LLC
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:MEDI0382; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49 [Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal]
Cohort 1: Percent Change From Baseline in Body Weight to Day 50 [Day 1 through Day 50]

Linked records (2)

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
R0012602	From In Vitro Efficacy to Long-Term HbA1c Response for GLP-1R/GlucagonR Agonism Using the 4GI-HbA1c Systems Model. Bosch R, CPT: pharmacometrics & systems pharmacology	2025	Nonrandomized study	PMID 40665896 DOI	cites ClinicalTrials.gov:NCT03244800; registry reference DERIVED:40665896
R0021115	Efficacy, Safety, and Mechanistic Insights of Cotadutide, a Dual Receptor Glucagon-Like Peptide-1 and Glucagon Agonist. Parker VER, The Journal of clinical endocrinology and metabolism	2020	Randomized trial	PMID 31608926 DOI	cites ClinicalTrials.gov:NCT03244800; registry reference DERIVED:31608926