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
- Conditions
- Type 2 Diabetes
- Registration Number
- JPRN-jRCT2080224025
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 60
Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening
- Individuals who are diagnosed with T2DM
- Individuals whose current condition at enrolment (Visit 1) is drug naive
- BMI within the range of 24 - 40 kg/m2 (inclusive) at screening
- Subjects with any of the following results at screening:
Aspartate transaminase (AST) 2.5 X upper limit of normal (ULN) or more
Alanine transaminase (ALT) 2.5 X ULN or more
Total bilirubin (TBL) 2 X ULN or more
Impaired renal function defined as estimated glomerular filtration rate (eGFR) 60 mL/minute/1.73 m2 or less at screening
- Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method