Dose Response Study in Japanese Patients

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00261417
First received: December 1, 2005
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

This is a 12-week study to determine the effect on glucose and lipids, safety, and tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week follow-up.


Condition Intervention Phase
Type 2 Diabetes
Drug: Tesaglitazar
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicentre, Placebo-Controlled Study to Evaluate the Efficacy, Dose-Response and Safety of Tesaglitazar Therapy in Japanese Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Dose-response relationship of tesaglitazar in subjects with type 2 diabetes by the assessment of the effects of each of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) to placebo with respect to fasting plasma glucose

Secondary Outcome Measures:
  • Changes in the following variables from baseline to the end of the randomized treatment period:
  • Triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, total cholesterol apolipoproteins (Apo) (Apo A-I, Apo B and Apo CIII), and f
  • Glucose and insulin values during an oral glucose tolerance test
  • Effects on the reduction of insulin and glycosylated hemoglobin A1c levels
  • Effects on the proportion of fasting plasma glucose responders
  • Effects on the proportion of high-density lipoprotein cholesterol responders
  • Effects on the changes from baseline in weight and waist/hip ratio
  • Evaluate the pharmacokinetics of tesaglitazar
  • Assess the safety and tolerability of tesaglitazar compared to placebo

Estimated Enrollment: 250
Study Start Date: May 2004
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of a written informed consent
  • Men or women who are >=18 years of age
  • Female patients: postmenopausal, hysterectomized
  • Diagnosed with type 2 diabetes
  • Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral anti-diabetic agents

Exclusion Criteria:

  • Type 1 diabetes
  • New York Heart Association heart failure Class III or IV
  • Treatment with chronic insulin
  • History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
  • History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
  • Creatinine levels above twice the normal range
  • Creatine kinase above 3 times the upper limit of normal
  • Received any investigational product in other clinical studies within 12 weeks
  • Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
  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: NCT00261417

Locations
Japan
Research Site
Ashino, Japan
Research Site
Fuchu Keijinkai, Japan
Research Site
Fujimino, Japan
Research Site
Hijirino Koike, Japan
Research Site
Houseikai, Japan
Research Site
Hyuga, Japan
Research Site
Iriuchijima, Japan
Research Site
Iwase, Japan
Research Site
Kato, Japan
Research Site
Kawamata, Japan
Research Site
Keishukai Shirakawa, Japan
Research Site
Koga, Japan
Research Site
Kouhoku, Japan
Research Site
Kousei, Japan
Research Site
Kurosawa, Japan
Research Site
Nihonmatu, Japan
Research Site
Oki, Japan
Research Site
Saiseikai Fukuoka, Japan
Research Site
Sapporo, Japan
Research Site
Takamori, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00261417     History of Changes
Other Study ID Numbers: D6160L00001, SH-SBD-0013
Study First Received: December 1, 2005
Last Updated: April 21, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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 10, 2014