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

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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: AZD1656; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Research Site
  • Tokyo, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Klas Malmberg, MD, AstraZeneca R&D Mölndal; Principal Investigator: Takashi Eto, MD, PhD, PS Clinic, Fukuoka, Japan; Principal Investigator: Mitsuyasu Hokamura, MD, HONJO CLINIC II, Tokyo, Japan

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 8, 2009
• First Posted (Estimate): June 9, 2009

Study Record Updates

• Last Update Posted (Estimate): November 3, 2009
• Last Update Submitted That Met QC Criteria: November 2, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Japanese; Multiple ascending doses; T2DM; Pharmacodynamic; AZD1656
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1020C00004