Study S002039

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects With Type 2 Diabetes Mellitus and Renal Impairment

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

Registration

Registration: NCT03550378
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 41
Start: 2018-06-29
Primary completion: 2019-02-04
Lead sponsor: MedImmune LLC
Conditions: Type II Diabetes Mellitus; Renal Insufficiency
Interventions: DRUG:MEDI0382; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2018-000019-26; NIH:2018

Registered primary outcomes

Percent Change From Baseline in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4 Hrs) as Measured by Mixed-meal Tolerance Test (MMTT) to Day 32 [Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -5 (Baseline) and Day 32]

Linked records (4)

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
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT03550378; registry reference DERIVED:39963952
R0019218	Efficacy and safety of cotadutide, a dual glucagon-like peptide-1 and glucagon receptor agonist, in a randomized phase 2a study of patients with type 2 diabetes and chronic kidney disease. Parker VER, Diabetes, obesity & metabolism	2022	Randomized trial	PMID 35403793 DOI	cites ClinicalTrials.gov:NCT03550378; registry reference DERIVED:35403793
R0044061	Efficacy and Safety of Cotadutide, a Dual GLP-1 and Glucagon Receptor Agonist in Patients with T2DM and DKD Victoria E Parker (16613325), Figshare	2021	Randomized trial		cites ClinicalTrials.gov:NCT03550378
R0050369	674-P: Efficacy and Safety of Cotadutide, a Dual GLP-1 and Glucagon Receptor Agonist in Patients with T2DM and DKD Victoria Parker, Diabetes	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03550378