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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014