Clinical trial NCT00300105: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 4
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Secondary outcomes:
measure: Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
measure: Time to treatment failure
measure: Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
measure: Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
measure: Markers of insulin resistance by assessment of insulin homeostasis assessment model
measure: Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
measure: 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
measure: Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
measure: Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
measure: Urinary albumin excretion
measure: Central obesity (waist circumference, hip circumference and waist/hip ratio)
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Sint-Gillis-Waas
country: Belgium
facility: Research Site
city: Steenokkerzeel
country: Belgium
facility: Research Site
city: Shatin
country: Hong Kong
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Gubbio
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Piacenza
country: Italy
facility: Research Site
city: Reggio Emilia
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Kubang Kerian
country: Malaysia
facility: Research Site
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Makati City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Pasig City
country: Philippines
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Plock
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Tychy
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: £ód?
country: Poland
facility: Research Site
city: Banská Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Ilava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kysucke Nove Mesto
country: Slovakia
facility: Research Site
city: Lubochna
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: