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

AstraZeneca1 site in 1 country24 target enrollmentMay 2009

ConditionsType 2 Diabetes

InterventionsAZD1656 Placebo

DrugsAZD1656 Placebo

Overview

Phase: Phase 1
Intervention: AZD1656
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Enrollment: 24
Locations: 1
Primary Endpoint: Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

October 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility 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/m
•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.

Arms & Interventions

A

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

Intervention: AZD1656

B

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

Intervention: Placebo

Outcomes

Primary Outcomes

Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG

Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions

Secondary Outcomes

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)