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Dose Response Study in Japanese Patients

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Tesaglitazar
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

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

Full Information

First Posted
December 1, 2005
Last Updated
April 21, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00261417
Brief Title
Dose Response Study in Japanese Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
The development program has been terminated
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tesaglitazar
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in the following variables from baseline to the end of the randomized treatment period:
Title
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
Title
Glucose and insulin values during an oral glucose tolerance test
Title
Effects on the reduction of insulin and glycosylated hemoglobin A1c levels
Title
Effects on the proportion of fasting plasma glucose responders
Title
Effects on the proportion of high-density lipoprotein cholesterol responders
Title
Effects on the changes from baseline in weight and waist/hip ratio
Title
Evaluate the pharmacokinetics of tesaglitazar
Title
Assess the safety and tolerability of tesaglitazar compared to placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Japan Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Ashino
Country
Japan
Facility Name
Research Site
City
Fuchu Keijinkai
Country
Japan
Facility Name
Research Site
City
Fujimino
Country
Japan
Facility Name
Research Site
City
Hijirino Koike
Country
Japan
Facility Name
Research Site
City
Houseikai
Country
Japan
Facility Name
Research Site
City
Hyuga
Country
Japan
Facility Name
Research Site
City
Iriuchijima
Country
Japan
Facility Name
Research Site
City
Iwase
Country
Japan
Facility Name
Research Site
City
Kato
Country
Japan
Facility Name
Research Site
City
Kawamata
Country
Japan
Facility Name
Research Site
City
Keishukai Shirakawa
Country
Japan
Facility Name
Research Site
City
Koga
Country
Japan
Facility Name
Research Site
City
Kouhoku
Country
Japan
Facility Name
Research Site
City
Kousei
Country
Japan
Facility Name
Research Site
City
Kurosawa
Country
Japan
Facility Name
Research Site
City
Nihonmatu
Country
Japan
Facility Name
Research Site
City
Oki
Country
Japan
Facility Name
Research Site
City
Saiseikai Fukuoka
Country
Japan
Facility Name
Research Site
City
Sapporo
Country
Japan
Facility Name
Research Site
City
Takamori
Country
Japan

12. IPD Sharing Statement

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Dose Response Study in Japanese Patients

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