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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00916604
First received: June 8, 2009
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: AZD1656
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR). [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
  • Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide). [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2009
Study Completion Date: October 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916604

Locations
Japan
Research Site
Fukuoka, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Klas Malmberg, MD, PhD, Prof, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00916604     History of Changes
Other Study ID Numbers: D1020C00004
Study First Received: June 8, 2009
Last Updated: November 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
AZD1656
Safety
Pharmacokinetics
Pharmacodynamic
Multiple ascending doses
Japanese
T2DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014