Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated
      up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese
      subjects.

      The study D5674C00001 can be conducted with a reasonable expectation of safety and
      tolerability in Japanese T2DM patients. The design of this study has taken into account the
      known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as
      the translatable effects observed in nonclinical studies of MEDI0382.
    

Detailed description: 
      This is a randomized, parallel-group, placebo-controlled, double-blind, multicenter Phase Ⅱa
      study to evaluate the safety, efficacy, and pharmacokinetics of MEDI0382 in Japanese preobese
      and obese subjects with type 2 diabetes who have inadequate glycemic control with diet and
      exercise. Subject fulfilling all of the inclusion criteria and none of the exclusion criteria
      will be randomised in a 1:1:1:1 ratio to four treatment arms. This is a Phase IIa study
      designed to evaluate the dose range for MEDI0382 to explore the safety profile, as well as
      blood glucose control and weight loss effects of MEDI0382 in Japanese patients with T2DM. The
      design of this study has taken into account the known benefits and risks of GLP-1 receptor
      agonists and glucagon receptor agonists as well as the translatable effects observed in
      nonclinical studies of MEDI0382, such that benefit-risk balance for the Japanese preobese and
      obese patients with T2DM in this study is considered favourable. A treatment period of 48
      days is required to properly evaluate the dose range and safety and tolerability in three
      different doses. Inclusion of placebo in the study allows appropriate basis of AEs, glycaemic
      control, and weight loss. Benefits related to participation in this trial include close
      follow-up of a subject's diabetes and treatment with anti-diabetes agents. Although one of
      possible treatments is placebo, appropriate rescue therapy for worsening glycaemic control
      will be implemented if required.
    

Intervention name(s): MEDI0382 100 μg; MEDI0382 200 μg; MEDI0382 300 μg; PlaceboA; MEDI0382 50 ug; PlaceboB
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose; Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose; Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose; 1.0 mL liquid formulation per Vial; Solution for injection, 1.0 mL per vial, 50 ug; Solution for injection in 1.0 mL pre-filled syringe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; MEDI0382; D5674C00001; T2DM; Type 2 Diabetes