Trial | NCT00916604  Report issue

Title

To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients
A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    azd1656 ...

  • Study Participants

    24
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.
Study Started
May 31
2009
Study Completion
Oct 31
2009
Last Update
Nov 03
2009
Estimate

Drug AZD1656

Three increasing dose-steps with oral suspension, 8 days treatment

Drug Placebo

Placebo oral suspension, 8 days treatment

A Experimental

3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)

B Placebo Comparator

Placebo oral suspension given to 3 groups (2 on placebo in each group)

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.
No Results Posted