ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity

Type 2 Diabetes Clinical Trial

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

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
• 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

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

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.