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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 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)

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

Page last updated: August 23, 2015

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