A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Mellitus

Registration

Registration

NCT04208620

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

16

Start

2020-01-21

Primary completion

2020-07-08

Lead sponsor

AstraZeneca

Conditions

Type 2 Diabetes

Interventions

DRUG:Placebo; DRUG:Cotadutide

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Incidence of treatment-emergent adverse events (TEAEs) [Baseline until the follow-up period, 28 days post-last dose]
• Incidence of treatment-emergent serious adverse events (TESAEs) [Baseline until the follow-up period, 28 days post-last dose]
• Clinically important changes in 12-lead electrocardiogram (ECG) [Baseline until the follow-up period, 28 days post-last dose]
• Vital signs as measured by pulse rate (bpm) [Baseline until the follow-up period, 28 days post-last dose]
• Vital signs as measured by blood pressure (mmHg) [Baseline until the follow-up period, 28 days post-last dose]
• ABPM (Ambulatory blood pressure monitoring) to measure pulse rate (bpm) and blood pressure (mmHg) [Baseline until the follow-up period, 28 days post-last dose]
• Physical examination (abnormality to be reported as part of adverse events) [Baseline until the follow-up period, 28 days post-last dose]
• Clinical laboratory evaluations [Baseline until the follow-up period, 28 days post-last dose]