GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

• ClinicalTrials.gov Identifier: NCT00226330
• Recruitment Status: Terminated
• First Posted: September 27, 2005
• Last Update Posted: November 19, 2010
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Tracking Information

• First Submitted Date: September 23, 2005
• First Posted Date: September 27, 2005
• Last Update Posted Date: November 19, 2010
• Study Start Date: March 2005
• Actual Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2005)

• Adverse events
• Laboratory variables
• Physical examination
• Cardiac evaluation
• Hypoglycemic events
• Electrocardiogram
• Vital signs (blood pressure and pulse)
• Body weight

• Original Primary Outcome Measures (submitted: September 23, 2005): Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight

Current Secondary Outcome Measures (submitted: December 20, 2005)

• Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
• Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
• Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
• C-reactive protein (CRP)
• Central obesity (waist circumference, hip circumference, waist/hip ratio)
• Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)

Original Secondary Outcome Measures (submitted: September 23, 2005)

• Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
• Lipid variables (triglyderide, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
• Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
• CRP
• Central obesity (waist circumference, hip circumference, waist/hip ratio)
• Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
• Official Title: A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)
• Brief Summary: This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 2

Intervention

• Drug: Tesaglitazar
  (0.5 or 1 mg)
  Other Name: Galida
• Drug: Pioglitazone
  (15, 30 or 45 mg)
  Other Name: Actos

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: September 23, 2005): 1100
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2006
• Actual Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.
• Completed the last two visits of the randomized treatment period in GALLANT 6

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, or neutropenia (low white blood cells)
• Creatinine levels of above twice the normal range
• Creatine kinase of above 3 times the upper limit of normal
• Previous enrollment in this long-term extension study
• Any clinically significant abnormality identified by 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Brazil, Canada, Finland, Mexico, United Kingdom, United States

Administrative Information

• NCT Number: NCT00226330
• Other Study ID Numbers: D6160C00048
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: AstraZeneca
• Collaborators: Not Provided

Investigators

• Study Director: Galida Medical Science Director, MD; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: November 2010