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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00263965
Other study ID # D6160C09999
Secondary ID EudraCT No 2004-
Status Terminated
Phase Phase 2
First received December 9, 2005
Last updated March 14, 2008
Start date August 2005
Est. completion date July 2006

Study information

Verified date March 2008
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of Health
Study type Interventional

Clinical Trial Summary

This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.


Recruitment information / eligibility

Status Terminated
Enrollment 105
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- Provision of a written informed consent

- Men or women who are 30-70 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 antidiabetic 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Tesaglitazar

Metformin

Behavioral:
Dietary and lifestyle modification counseling


Locations

Country Name City State
Finland Research Site Helsinki
Italy Research Site Pisa
United Kingdom Research Site Oxford

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Finland,  Italy,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
Secondary Hepatic and peripheral insulin sensitivity by assessing the M value during low (20 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
Secondary Basal hepatic glucose output measured by dideuterated glucose in the fasting state and during low insulin level clamp.
Secondary Plasma profile of glucose, insulin and lipids after a mixed meal
Secondary Calculated insulin secretion
Secondary Liver oxidation after a mixed meal
Secondary Energy expenditure and substrate metabolism by indirect calorimetry
Secondary Body composition using DXA-scan, abdominal fat distribution using magnetic resonance imaging, liver fat and muscle fat content using magnetic resonance spectroscopy
Secondary Waist and hip circumference
Secondary Laboratory efficacy variables (lipids, inflammatory marker and adipose tissue hormones)
Secondary Safety and tolerability of tesaglitazar in patients with type 2 diabetes.
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