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

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tesaglitazar
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight

Secondary Outcome Measures

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)

Full Information

First Posted
March 7, 2006
Last Updated
March 14, 2008
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00300105
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
The development program has been terminated
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Galida Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Hasselt
Country
Belgium
Facility Name
Research Site
City
Liege
Country
Belgium
Facility Name
Research Site
City
Sint-Gillis-Waas
Country
Belgium
Facility Name
Research Site
City
Steenokkerzeel
Country
Belgium
Facility Name
Research Site
City
Shatin
Country
Hong Kong
Facility Name
Research Site
City
Balatonfured
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Kaposvar
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
Székesfehérvár
Country
Hungary
Facility Name
Research Site
City
Gubbio
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Perugia
Country
Italy
Facility Name
Research Site
City
Piacenza
Country
Italy
Facility Name
Research Site
City
Reggio Emilia
Country
Italy
Facility Name
Research Site
City
Udine
Country
Italy
Facility Name
Research Site
City
Kubang Kerian
State/Province
Kelantan
Country
Malaysia
Facility Name
Research Site
City
Kuala Lumpur
Country
Malaysia
Facility Name
Research Site
City
Makati City
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Pasig City
Country
Philippines
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Plock
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Tychy
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
£ód?
Country
Poland
Facility Name
Research Site
City
Banská Bystrica
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Ilava
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Kysucke Nove Mesto
Country
Slovakia
Facility Name
Research Site
City
Lubochna
Country
Slovakia
Facility Name
Research Site
City
Lucenec
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Presov
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

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

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