Dose Response Study in Japanese Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00261417

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 II

MedlinePlus related topics: Diabetes

Drug Information available for: Tesaglitazar

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261417

Locations

Japan
Research Site
Fujimino, Japan
Research Site
Kousei, Japan
Research Site
Hyuga, Japan
Research Site
Ashino, Japan
Research Site
Fuchu Keijinkai, Japan
Research Site
Takamori, Japan
Research Site
Koga, Japan
Research Site
Saiseikai Fukuoka, Japan
Research Site
Sapporo, Japan
Research Site
Keishukai Shirakawa, Japan
Research Site
Kato, Japan
Research Site
Kouhoku, Japan
Research Site
Nihonmatu, Japan
Research Site
Kurosawa, Japan
Research Site
Oki, Japan
Research Site
Hijirino Koike, Japan
Research Site
Houseikai, Japan
Research Site
Iriuchijima, Japan
Research Site
Kawamata, Japan
Research Site
Iwase, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Japan Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	D6160L00001, SH-SBD-0013
Study First Received:	December 1, 2005
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00261417
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009