GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT00300105
• Recruitment Status: Terminated
• First Posted: March 8, 2006
• Last Update Posted: March 17, 2008
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Tracking Information

• First Submitted Date: March 7, 2006
• First Posted Date: March 8, 2006
• Last Update Posted Date: March 17, 2008
• Study Start Date: October 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: March 7, 2006): Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 27, 2006)

• Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
• Time to treatment failure
• Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
• Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
• Markers of insulin resistance by assessment of insulin homeostasis assessment model
• Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
• Changes in lipid variables (triglyceride, total cholesterol, high-density lipoprotein cholesterol [HDL-C], non-HDL-C, low-density lipoprotein cholesterol, low-density lipoprotein cholesterol/HDL-C, apolipoprotein [Apo] B, ApoA-1, ApoB/ApoA-1
• Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
• Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
• Urinary albumin excretion
• Central obesity (waist circumference, hip circumference and waist/hip ratio)

Original Secondary Outcome Measures (submitted: March 7, 2006)

• Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
• - Time to treatment failure
• - Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
• - Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
• - Markers of insulin resistance by assessment of insulin homeostasis assessment model
• - Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
• - Changes in lipid variables (triglyceride, total cholesterol, high-density lipoprotein cholesterol [HDL-C], non-HDL-C, low-density lipoprotein cholesterol, low-density lipoprotein cholesterol/HDL-C, apolipoprotein [Apo] B, ApoA-1, ApoB/ApoA-1
• - Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
• - Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
• - Urinary albumin excretion
• - Central obesity (waist circumference, hip circumference and waist/hip ratio)

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

Descriptive Information

• Brief Title: GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes
• Official Title: A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar Therapy in Patients With Type 2 Diabetes
• Brief Summary: This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 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: Type 2 Diabetes
• Intervention: Drug: Tesaglitazar
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: March 7, 2006): 400
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2006
• Primary Completion Date: Not Provided

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 randomized treatment period in GALLANT 4

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
• Previous enrollment in this long-term extension study
• 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

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: Belgium, Hong Kong, Hungary, Italy, Malaysia, Philippines, Poland, Slovakia, South Africa, Thailand

Administrative Information

• NCT Number: NCT00300105
• Other Study ID Numbers: D6160C00047; EudraCT No 2004-005243-97
• 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: AstraZeneca Galida Medical Science Director, MD; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: March 2008