GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Tesaglitazar (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): AstraZeneca Galida Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Secondary outcome: Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs onTime 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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Research Site, Hasselt, Belgium
Research Site, Liege, Belgium
Research Site, Sint-Gillis-Waas, Belgium
Research Site, Steenokkerzeel, Belgium
Research Site, Shatin, Hong Kong
Research Site, Balatonfured, Hungary
Research Site, Budapest, Hungary
Research Site, Kaposvar, Hungary
Research Site, Kecskemet, Hungary
Research Site, Székesfehérvár, Hungary
Research Site, Gubbio, Italy
Research Site, Milano, Italy
Research Site, Perugia, Italy
Research Site, Piacenza, Italy
Research Site, Reggio Emilia, Italy
Research Site, Udine, Italy
Research Site, Kuala Lumpur, Malaysia
Research Site, Makati City, Philippines
Research Site, Manila, Philippines
Research Site, Pasig City, Philippines
Research Site, Kraków, Poland
Research Site, Lublin, Poland
Research Site, Plock, Poland
Research Site, Torun, Poland
Research Site, Tychy, Poland
Research Site, Warszawa, Poland
Research Site, £ód?, Poland
Research Site, Banská Bystrica, Slovakia
Research Site, Bratislava, Slovakia
Research Site, Ilava, Slovakia
Research Site, Kosice, Slovakia
Research Site, Kysucke Nove Mesto, Slovakia
Research Site, Lubochna, Slovakia
Research Site, Lucenec, Slovakia
Research Site, Nitra, Slovakia
Research Site, Presov, Slovakia
Research Site, Trnava, Slovakia
Research Site, Cape Town, South Africa
Research Site, Durban, South Africa
Research Site, Bangkok, Thailand
Research Site, Johannesburg, Gauteng, South Africa
Research Site, Kubang Kerian, Kelantan, Malaysia
Additional Information
Starting date: October 2005
Last updated: March 14, 2008
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