A Randomized, Single-Blind, Placebo-Controlled, Multi-Centre, PhaseI Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients
Phase 1
- Conditions
- Type 2 Diabetes
- Registration Number
- JPRN-jRCT2080220768
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
A body mass index (BMI) of 18 to 27 kg/m2.
- Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.
Exclusion Criteria
- Renal dysfunction GFR <60mL/min.
- Systolic pressure (SBP) >160mmHg or diastolic pressure (DBP) >95mmHg.
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
- History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method