GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate
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ClinicalTrials.gov Identifier: NCT00261352 |
Recruitment Status :
Terminated
(The development program has been terminated)
First Posted : December 5, 2005
Last Update Posted : April 22, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: Tesaglitazar Drug: Metformin Drug: Fenofibrate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 1000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin |
Study Start Date : | March 2005 |
Actual Study Completion Date : | December 2006 |

- The change in HDL-C from baseline to the end of the randomized treatment period.
- Changes in the following variables from baseline to the end of the randomized treatment period:
- Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
- Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
- The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
- Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
- Central obesity (waist/hip ratio)
- Pharmacokinetics of tesaglitazar
- Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provision of a written informed consent
- Men or women who are >=18 years of age
- Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
- 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 the normal range
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261352

Study Director: | AstraZeneca Galida Medical Science DIrector, MD | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00261352 |
Other Study ID Numbers: |
D6160C00003 EudraCT No 2004-02550-56 |
First Posted: | December 5, 2005 Key Record Dates |
Last Update Posted: | April 22, 2009 |
Last Verified: | April 2009 |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Fenofibrate |
Hypoglycemic Agents Physiological Effects of Drugs Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |