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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: AZD1656; Drug: Placebo

• Registration Number: NCT00916604
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Study Completion: 2009-10
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-02
• Last Update Posted: 2009-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	AZD1656	3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)
B	Placebo	Placebo oral suspension given to 3 groups (2 on placebo in each group)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan