Study S000451

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects With a History of Type 2 Diabetes Mellitus

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

Registration

Registration: NCT02548585
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1; PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 113
Start: 2015-12-09
Primary completion: 2017-02-24
Lead sponsor: MedImmune LLC
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:MEDI0382; DRUG:Placebo
Results posted: TRUE

Registered primary outcomes

Percent Change From Baseline in Mixed-meal Test (MMT) Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours to the End of Treatment (EOT) (Cohort 4) [0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post standardized meal intake (SMI) on Baseline (Day -1) and EOT (Day 41)]
Change From Baseline in Body Weight to the EOT (Cohort 4) [Baseline (Day 1) and EOT (Day 42)]

Linked records (6)

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
R0016079	Characterisation of cotadutide's dual GLP-1/glucagon receptor agonistic effects on glycaemic control using an in vivo human glucose regulation quantitative systems pharmacology model. Bosch R, British journal of pharmacology	2024	Other trial	PMID 38403793 DOI	cites ClinicalTrials.gov:NCT02548585; registry reference DERIVED:38403793
R0022760	MEDI0382, a GLP-1 and glucagon receptor dual agonist, in obese or overweight patients with type 2 diabetes: a randomised, controlled, double-blind, ascending dose and phase 2a study. Ambery P, Lancet (London, England)	2018	Randomized trial	PMID 29945727 DOI	cites ClinicalTrials.gov:NCT02548585; registry reference DERIVED:29945727
R0048739	Effects of MEDI0382 on Pancreatic and Incretin Hormones Victoria Parker, Diabetes	2018	Other	DOI	cites ClinicalTrials.gov:NCT02548585
R0048994	Robust Glucose Control and Weight Loss after Six Weeks of Treatment with MEDI0382, a Balanced GLP-1/Glucagon Receptor Dual Agonist, in Patients with Type 2 Diabetes Phil Ambery, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02548585
R0053009	MEDI0382, a GLP-1/Glucagon Receptor Dual Agonist, in Patients with Type 2 Diabetes—A Multiple-Ascending-Dose Study Darren C. Robertson, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02548585
R0053354	MEDI0382, a GLP/Glucagon Receptor Dual Agonist, Significantly Reduces Hepatic Fat Content in Subjects with Type 2 Diabetes Mellitus Meena Jain, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02548585