NCT00261417

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2 type-2-diabetes

Timeline
Completed

Started May 2004

Geographic Reach
1 country

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

First QC Date

December 1, 2005

Last Update Submit

April 21, 2009

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Interventions

TesaglitazarDRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

Ashino, Japan

Location

Research Site

Fuchu Keijinkai, Japan

Location

Research Site

Fujimino, Japan

Location

Research Site

Hijirino Koike, Japan

Location

Research Site

Houseikai, Japan

Location

Research Site

Hyūga, Japan

Location

Research Site

Iriuchijima, Japan

Location

Research Site

Iwase, Japan

Location

Research Site

Katō, Japan

Location

Research Site

Kawamata, Japan

Location

Research Site

Keishukai Shirakawa, Japan

Location

Research Site

Koga, Japan

Location

Research Site

Kōhoku, Japan

Location

Research Site

Kōsei, Japan

Location

Research Site

Kurosawa, Japan

Location

Research Site

Nihonmatu, Japan

Location

Research Site

Oki, Japan

Location

Research Site

Saiseikai Fukuoka, Japan

Location

Research Site

Sapporo, Japan

Location

Research Site

Takamori, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazar

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • AstraZeneca Japan Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 5, 2005

Study Start

May 1, 2004

Study Completion

October 1, 2005

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations

JP(20)