A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MEDI0382 in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

Registration

Registration

NCT03745937

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

QUADRUPLE

Status

COMPLETED

Enrollment

20

Start

2019-01-07

Primary completion

2019-05-28

Lead sponsor

MedImmune LLC

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG:MEDI0382; DRUG:Placebo

Results posted

TRUE

Registered primary outcomes

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Through the End of the Up-titration Period [Baseline (Day -1) through Day 56 (end of Up-titration period)]
• Number of Participants With TEAEs and TESAEs Through the End of the Follow-up Period [Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)]
• Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs Through the End of the Up-titration Period [Baseline (Day -1) through Day 56 (end of Up-titration period)]
• Number of Participants With Abnormal ECGs Reported as TEAEs Through the End of the Follow-up Period [Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)]
• Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Up-titration Period [Baseline (Day -1) through Day 56 (end of Up-titration period)]
• Number of Participants With Abnormal Vital Signs Reported as TEAEs Through the End of the Follow-up Period [Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)]
• Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Up-titration Period [Baseline (Day -1) through Day 56 (end of Up-titration period)]
• Number of Participants With Abnormal Physical Examinations Reported as TEAEs Through the End of the Follow-up Period [Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)]
• Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Up-titration Period [Baseline (Day -1) through Day 56 (end of Up-titration period)]
• Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Through the End of the Follow-up Period [Baseline (Day-1) through 28 days post last dose (end of follow-up period; approximately up to 5 months)]