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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00300105
• Other study ID #: D6160C00047
• Secondary ID: EudraCT No 2004-
• Status: Terminated
• Phase: Phase 3
• First received: March 7, 2006
• Last updated: March 14, 2008
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: March 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tesaglitazar

Locations

Country	Name	City	State
Belgium	Research Site	Hasselt
Belgium	Research Site	Liege
Belgium	Research Site	Sint-Gillis-Waas
Belgium	Research Site	Steenokkerzeel
Hong Kong	Research Site	Shatin
Hungary	Research Site	Balatonfured
Hungary	Research Site	Budapest
Hungary	Research Site	Kaposvar
Hungary	Research Site	Kecskemet
Hungary	Research Site	Székesfehérvár
Italy	Research Site	Gubbio
Italy	Research Site	Milano
Italy	Research Site	Perugia
Italy	Research Site	Piacenza
Italy	Research Site	Reggio Emilia
Italy	Research Site	Udine
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kubang Kerian	Kelantan
Philippines	Research Site	Makati City
Philippines	Research Site	Manila
Philippines	Research Site	Pasig City
Poland	Research Site	£ód?
Poland	Research Site	Kraków
Poland	Research Site	Lublin
Poland	Research Site	Plock
Poland	Research Site	Torun
Poland	Research Site	Tychy
Poland	Research Site	Warszawa
Slovakia	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
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg	Gauteng
Thailand	Research Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Secondary	Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
Secondary	Time to treatment failure
Secondary	Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
Secondary	Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
Secondary	Markers of insulin resistance by assessment of insulin homeostasis assessment model
Secondary	Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
Secondary	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
Secondary	Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
Secondary	Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
Secondary	Urinary albumin excretion
Secondary	Central obesity (waist circumference, hip circumference and waist/hip ratio)