ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity

Overview[ - collapse ][ - ]

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.
ConditionType 2 Diabetes
InterventionDrug: Tesaglitazar
Drug: Metformin
Behavioral: Dietary and lifestyle modification counseling
PhasePhase 2
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00263965
First ReceivedDecember 9, 2005
Last UpdatedMarch 14, 2008
Last verifiedMarch 2008

Tracking Information[ + expand ][ + ]

First Received DateDecember 9, 2005
Last Updated DateMarch 14, 2008
Start DateAugust 2005
Estimated Primary Completion DateJuly 2006
Current Primary Outcome MeasuresWhole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
Current 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.

Descriptive Information[ + expand ][ + ]

Brief TitleARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
Official TitleA 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
Brief 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: Tesaglitazar
Drug: Metformin
Behavioral: Dietary and lifestyle modification counseling
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment105
Estimated Completion DateJuly 2006
Estimated Primary Completion DateNot Provided
Eligibility 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
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesFinland, Italy, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT00263965
Other Study ID NumbersD6160C09999
Has Data Monitoring CommitteeNot Provided
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsNot Provided
Investigators Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
Verification DateMarch 2008

Locations[ + expand ][ + ]

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