Safety and tolerability study of MEDI0382 in Japanese preobese or obese subjects with type 2 diabetes

Study identifier:D5674C00001

ClinicalTrials.gov identifier:NCT03645421

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase IIa, Randomised, Parallel, Double-Blind,Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MEDI0382 in Japanese Preobese or Obese Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise

Medical condition

Type 2 Diabetes

Phase

Phase 2

Healthy volunteers

No

Study drug

MEDI0382 100 μg, MEDI0382 100 μg, MEDI0382 100 μg, MEDI0382 200 μg, MEDI0382 200 μg, MEDI0382 300 μg, PlaceboA, MEDI0382 50 ug, MEDI0382 50 ug, MEDI0382 50 ug, PlaceboB

Sex

All

Actual enrollment

61

Study type

Interventional

Age

20 Years - 120 Years

Date

Study Start Date: 10 Aug 2018
Primary Completion Date: 17 Jan 2019
Study Completion Date: 17 Jan 2019

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria