Type 2 Diabetes
Conditions
Interventions
investigational material(s)
Generic name etc : MEDI0382
INN of investigational material : -
Therapeutic category code : 249 Other hormone preparations (including antihormone preparations)
Dosage and A
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics - | — |
Countries
Japan
Outcome results
None listed