Dose Response Study in Japanese Patients

NCT ID: NCT00261417

Last Updated: 2009-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tesaglitazar

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Japan Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Ashino, , Japan

Site Status

Research Site

Fuchu Keijinkai, , Japan

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Fujimino, , Japan

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Hijirino Koike, , Japan

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Houseikai, , Japan

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Hyūga, , Japan

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Iriuchijima, , Japan

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Iwase, , Japan

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Katō, , Japan

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Kawamata, , Japan

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Keishukai Shirakawa, , Japan

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Koga, , Japan

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Kōhoku, , Japan

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Kōsei, , Japan

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Kurosawa, , Japan

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Nihonmatu, , Japan

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Oki, , Japan

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Saiseikai Fukuoka, , Japan

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Sapporo, , Japan

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Research Site

Takamori, , Japan

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Countries

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Japan

Other Identifiers

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SH-SBD-0013

Identifier Type: -

Identifier Source: secondary_id

D6160L00001

Identifier Type: -

Identifier Source: org_study_id

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