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A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes


Phase 3
18 Years
N/A
Not Enrolling
Both
Type 2 Diabetes

Thank you

Trial Information

A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes


Inclusion Criteria:



- Provision of a written informed consent

- Men or women who are >=18 years of age

- Female patients: postmenopausal, hysterectomized, or if of childbearing potential,
using a reliable method of birth control

- Diagnosed with type 2 diabetes

- Treated with diet alone or treatment with a single oral antidiabetic agent or low
doses of two oral antidiabetic agents

- Drug-naïve (ie, no use of antidiabetic drug[s] for at least 24 weeks prior to visit
1).

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Principal Investigator

AstraZeneca Galida Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Finland: Finnish Medicines Agency

Study ID:

D6160C00026

NCT ID:

NCT00252772

Start Date:

September 2004

Completion Date:

November 2006

Related Keywords:

  • Type 2 Diabetes
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2

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