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

Type 2 Diabetes Clinical Trial

— JMAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916604
• Other study ID #: D1020C00004
• Status: Completed
• Phase: Phase 1
• First received: June 8, 2009
• Last updated: November 2, 2009
• Start date: May 2009
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• AZD1656
Three increasing dose-steps with oral suspension, 8 days treatment
• Placebo
Placebo oral suspension, 8 days treatment

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR).		Blood samples taken repeatedly during 24 hours on study day sessions	No
Secondary	Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide).		Blood samples taken repeatedly during 24 hours on study day sessions	No