To evaluate safety and tolerability after multiple oral doses of AZD1656 in type 2 diabetes patients on top of metformi
Phase 1
Completed
- Registration Number
- CTRI/2009/091/000774
- Lead Sponsor
- AstraZeneca AB, 151 85 Södertälje, Sweden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Male or female (with non child-bearing potential)
- Diagnosed diabetes Mellitus patientstreated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
- HbA1c <11 % at screening (HbA1c value according to international DCCT standard)
Exclusion Criteria
- 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, transitorisk ischemic attack or symptomatic peripheral vascular disease
- Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)Timepoint: Blood samples taken repeatedly during 24 hours on study day sessions
- Secondary Outcome Measures
Name Time Method Pharmacodynamic variablesTimepoint: Blood samples taken repeatedly during 24 hours on study day sessions;Pharmacokinetic variablesTimepoint: Blood samples taken repeatedly during 24 hours on study day sessions