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TerminatedNCT00261417Updated Apr 22, 2009

Dose Response Study in Japanese Patients

A Phase 2 interventional study of Tesaglitazar in Type 2 Diabetes, sponsored by AstraZeneca. Terminated at 20 sites in Japan. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-04-22.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Why this study was terminated
The development program has been terminated
Phase
Phase 2
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 250 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
250 participants

Interventions

  • DrugTesaglitazar
06

What researchers measure

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

  1. Changes in the following variables from baseline to the end of the randomized treatment period:

  2. 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

  3. Glucose and insulin values during an oral glucose tolerance test

  4. Effects on the reduction of insulin and glycosylated hemoglobin A1c levels

  5. Effects on the proportion of fasting plasma glucose responders

  6. Effects on the proportion of high-density lipoprotein cholesterol responders

  7. Effects on the changes from baseline in weight and waist/hip ratio

  8. Evaluate the pharmacokinetics of tesaglitazar

  9. Assess the safety and tolerability of tesaglitazar compared to placebo

07

Study locations

20 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00261417
Lead sponsor
AstraZeneca
First posted
Dec 5, 2005
Start date
May 2004
Completion
Oct 2005
Last update
Apr 22, 2009

Study contacts

AstraZeneca Japan Medical Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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