ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00263965

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Tesaglitazar Drug: Metformin Behavioral: Dietary and lifestyle modification counseling	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Metformin Metformin hydrochloride Tesaglitazar

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.

Secondary Outcome Measures:

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.

Estimated Enrollment:	105
Study Start Date:	August 2005
Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263965

Locations

Finland
Research Site
Helsinki, Finland
Italy
Research Site
Pisa, Italy
United Kingdom
Research Site
Oxford, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Galida Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	D6160C09999, EudraCT No 2004-000350-24
Study First Received:	December 9, 2005
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00263965
Health Authority:	United Kingdom: Department of Health

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009