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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00916604

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: AZD1656 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)	Drug: AZD1656 Three increasing dose-steps with oral suspension, 8 days treatment
Placebo Comparator: B Placebo oral suspension given to 3 groups (2 on placebo in each group)	Drug: Placebo Placebo oral suspension, 8 days treatment

Arm

Intervention/Treatment

Experimental: A

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

Drug: AZD1656

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

Placebo Comparator: B

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

Drug: Placebo

Placebo oral suspension, 8 days treatment

Outcome Measures

Primary Outcome Measures

Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG [Blood samples taken repeatedly during 24 hours on study day sessions]

Secondary Outcome Measures

Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR). [Blood samples taken repeatedly during 24 hours on study day sessions]
Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide). [Blood samples taken repeatedly during 24 hours on study day sessions]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.