Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients

A 4-month Treatment, Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of Different Dosing Regimens of AZD1656 as Monotherapy in Japanese Type 2 Diabetes Mellitus Patients

The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.

Inclusion Criteria:

• women of non-childbearing potential.
• Provision of informed consent prior to any study specific procedures
• Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit (Visit1)

Exclusion Criteria:

• Clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, hepatic disease and haematological disease.
• The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
• Participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit