Study identifier:D5674C00001
ClinicalTrials.gov identifier:NCT03645421
EudraCT identifier:N/A
CTIS identifier:N/A
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
Type 2 Diabetes
Phase 2
No
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
All
61
Interventional
20 Years - 120 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2019 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: placebo Placebo per day,SC injection on 48 days. | Drug: PlaceboA 1.0 mL liquid formulation per Vial Drug: PlaceboB Solution for injection in 1.0 mL pre-filled syringe. |
Experimental: MEDI0382 100μg 50 μg/day,SC injection on the first 5 days and 100 μg/day,SC injection on 43 days | Drug: MEDI0382 100 μg Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose Drug: MEDI0382 50 ug Solution for injection, 1.0 mL per vial, 50 ug |
Experimental: MEDI0382 200μg 50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days and 200 μg/day,SC injection on 36 days. | Drug: MEDI0382 100 μg Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose Drug: MEDI0382 200 μg Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose Drug: MEDI0382 50 ug Solution for injection, 1.0 mL per vial, 50 ug |
Experimental: MEDI0382 300μg 50 μg/day,SC injection on the first 5 days, 100 μg/day,SC injection on 7 days, 200 μg/day,SC injection on 7 days and 300 μg/day,SC injection on 29 days | Drug: MEDI0382 100 μg Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose Drug: MEDI0382 200 μg Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose Drug: MEDI0382 300 μg Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose Drug: MEDI0382 50 ug Solution for injection, 1.0 mL per vial, 50 ug |