Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients

An Open-label, Randomised, Placebo Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics of Digoxin During Co-administration With AZD1656

The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.

Inclusion Criteria:

• Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.
• Body mass index between ≥19 and ≤42 kg/m2.
• Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.

Exclusion Criteria:

• History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
• Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening
• Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors