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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00916604

Acronym

JMAD

Enrollment

Registered

2009-06-09

Start date

2009-05-31

Completion date

2009-10-31

Last updated

2009-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

AZD1656, Safety, Pharmacokinetics, Pharmacodynamic, Multiple ascending doses, Japanese, T2DM

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.

Interventions

DRUGAZD1656

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

DRUGPlacebo

Placebo oral suspension, 8 days treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

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.

Design outcomes

Primary

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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026