Study S000257

A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of 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: NCT03235050
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: TRIPLE
Status: COMPLETED
Enrollment: 834
Start: 2017-08-02
Primary completion: 2018-05-03
Lead sponsor: AstraZeneca
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:MEDI0382 low dose; DRUG:MEDI0382 mid dose; DRUG:MEDI0382 high dose; DRUG:Placebo; DRUG:Liraglutide
Results posted: TRUE

Registered primary outcomes

Change in HbA1c [From baseline to 14 weeks]
Percent Change in Body Weight [From baseline to 14 weeks]

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
R0016374	Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study. Nahra R, Diabetes care	2021	Randomized trial	PMID 34016612 DOI	cites ClinicalTrials.gov:NCT03235050; registry reference DERIVED:34016612
R0040401	Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults with Overweight or Obesity and Type 2 Diabetes Mellitus: A 54-Week Randomized Phase 2b Study Rajaa Nahra	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03235050