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Completed

NCT Number: NCT00916604

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1656

Drug

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

Placebo

Drug

Placebo oral suspension, 8 days treatment

Primary outcomes

  1. 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

  1. Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR).

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

  2. Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide).

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: JMAD

Important dates

Study start
2009
Study completion
2009
First posted
Jun 9, 2009
Registry last updated
Nov 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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