A Phase 1/2, Randomized, Double-blind,Placebo-controlled, Multiple-ascending-dose Studyto Evaluate the Efficacy, Safety, and Pharmacokineticsof MEDI0382 in Overweight and Obese Subjectswith a History of Type 2 Diabetes Mellitus

Phase 1

Recruiting

• Conditions: E11; Diabetes, Adipositas; E66; Type 2 diabetes mellitus; Obesity

• Registration Number: DRKS00010275
• Lead Sponsor: MedImmune Limited, a wholly owned subsidiary of AstraZeneca PLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

The study population will consist of male or female adults, 18 through 65 years of age with T2DM and body mass index 27 to 40 kg/m2 (inclusive), without significant late diabetic complications. Subjects should have been treated with a stable dose of oral blood glucose lowering therapy for 3 months prior to screening (metformin monotherapy or metformin plus dipeptidyl peptidase-4 [DPPIV], sulphonylurea [50% of the licensed dose], or a sodium-glucose co-transporter 2 [SGLT2]; and DPPIV inhibitor, sulphonylurea, or SGLT2 inhibitor is washed out prior to randomization).

Exclusion Criteria

Females of childbearing potential and lactating females will be excluded.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to assess the effect of MEDI0382 on glucose control (as measured by the standardized MMT glucose data) and body weight from baseline to the end of a 4 week treatment period at a stable dose.