A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients

A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After High Single Ascending Oral Supratherapeutic Doses of AZD1656 in Male Type 2 Diabetes Mellitus (T2DM) Patients

The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Male, T2DM patients aged 20-60 years
• Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
• Patients should not have been treated with glitazones within 6 months prior to enrollment
• Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).

Exclusion Criteria:

• History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
• Prolonged QTcF>450 msec or shortened QTcF<350 msec or family history of long QT syndrome.
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
• Systolic BP>159 mmHg or diastolic BP>99 mmHg at screening and on Day-1