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

Registration

Registration

NCT03645421

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

DOUBLE

Status

COMPLETED

Enrollment

61

Start

2018-08-10

Primary completion

2019-01-17

Lead sponsor

AstraZeneca

Conditions

Type 2 Diabetes

Interventions

DRUG:MEDI0382 100 μg; DRUG:MEDI0382 200 μg; DRUG:MEDI0382 300 μg; DRUG:PlaceboA; DRUG:MEDI0382 50 ug; DRUG:PlaceboB

Results posted

TRUE

Registered primary outcomes

• Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48 [Baseline (Day -1) and Days 20 and 48.]
• Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48 [Baseline (Day -1) and Days 20 and 48.]
• Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48 [Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal.]
• Mean Percentage Change From Baseline in Body Weight at Day 48 [Baseline (Day -1) and Day 48.]
• Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48. [Baseline (Day -1) and Days 1, 6, 13, 20 and 48: predose and 6 hours (+/-15 minutes) postdose.]
• Number of Patients Who Experienced Adverse Events (AEs) [Day 1 up to 14 days after the last dose of IP (approximately 9 weeks).]