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. |
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Condition | Type 2 Diabetes |
Intervention | Drug: Tesaglitazar Drug: Metformin Behavioral: Dietary and lifestyle modification counseling |
Phase | Phase 2 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00263965 |
First Received | December 9, 2005 |
Last Updated | March 14, 2008 |
Last verified | March 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | December 9, 2005 |
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Last Updated Date | March 14, 2008 |
Start Date | August 2005 |
Estimated Primary Completion Date | July 2006 |
Current Primary Outcome Measures | Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity |
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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 |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | Drug: Tesaglitazar Drug: Metformin Behavioral: Dietary and lifestyle modification counseling |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 105 |
Estimated Completion Date | July 2006 |
Estimated Primary Completion Date | Not 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 |
Gender | Both |
Ages | 30 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Finland, Italy, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00263965 |
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Other Study ID Numbers | D6160C09999 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Not Provided |
Investigators | Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca |
Verification Date | March 2008 |
Locations[ + expand ][ + ]
Research Site | Helsinki, Finland |
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Research Site | Pisa, Italy |
Research Site | Oxford, United Kingdom |