ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00263965
First received: December 9, 2005
Last updated: March 14, 2008
Last verified: March 2008

December 9, 2005
March 14, 2008
August 2005
Not Provided
Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
Same as current
Complete list of historical versions of study NCT00263965 on ClinicalTrials.gov Archive Site
  • Hepatic and peripheral insulin sensitivity by assessing the M value during low (20 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
  • Basal hepatic glucose output measured by dideuterated glucose in the fasting state and during low insulin level clamp.
  • Plasma profile of glucose, insulin and lipids after a mixed meal
  • Calculated insulin secretion
  • Liver oxidation after a mixed meal
  • Energy expenditure and substrate metabolism by indirect calorimetry
  • Body composition using DXA-scan, abdominal fat distribution using magnetic resonance imaging, liver fat and muscle fat content using magnetic resonance spectroscopy
  • Waist and hip circumference
  • Laboratory efficacy variables (lipids, inflammatory marker and adipose tissue hormones)
  • Safety and tolerability of tesaglitazar in patients with type 2 diabetes.
Same as current
Not Provided
Not Provided
 
ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
A 16-Week Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo- and Active- (Metformin) Controlled Study to Evaluate the Effect on Whole Body Insulin Sensitivity of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Tesaglitazar
  • Drug: Metformin
  • Behavioral: Dietary and lifestyle modification counseling
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
105
July 2006
Not Provided

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Italy,   United Kingdom
 
NCT00263965
D6160C09999, EudraCT No 2004-000350-24
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
AstraZeneca
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP