To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.

• A body mass index (BMI) of 19 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 < 60 mL/min.

• Systolic pressure (SBP) > 160 mmHg or diastolic pressure (DBP) > 95 mmHg

• 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.