Back to resultsGALLEX 1 - Long Term Extension Study 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
About this trial
This is an interventional treatment trial for Type 2 Diabetes
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 2/22, 5, 7, 8 or 14 studies. 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
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c, lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol
C-reactive protein
Central obesity (waist circumference, hip circumference, waist/hip ratio)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00252876
Brief Title
GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes
Official Title
An Open-Label, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 1 mg in Patients With Type 2 Diabetes Mellitus.
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
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (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
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c, lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol)
Title
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol
Title
C-reactive protein
Title
Central obesity (waist circumference, hip circumference, 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 2/22, 5, 7, 8 or 14 studies.
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
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Birmingham
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Mobile
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Finland
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Tampere
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Finland
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Turku
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Finland
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Finland
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Belgrade
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Former Serbia and Montenegro
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Athens
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Greece
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Hong Kong
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Hong Kong
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Italy
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Italy
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Italy
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Messina
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Italy
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Milano
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Italy
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Napoli
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Italy
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Padova
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Italy
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Italy
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Italy
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Daugavpils
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Latvia
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Madona
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Kuala Lumpur
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Facility Name
Research Site
City
Penang
Country
Malaysia
Facility Name
Research Site
City
Beek en Donk
Country
Netherlands
Facility Name
Research Site
City
Bennebroek
Country
Netherlands
Facility Name
Research Site
City
Den Haag
Country
Netherlands
Facility Name
Research Site
City
Deurne
Country
Netherlands
Facility Name
Research Site
City
Huizen
Country
Netherlands
Facility Name
Research Site
City
Losser
Country
Netherlands
Facility Name
Research Site
City
Nijverdal
Country
Netherlands
Facility Name
Research Site
City
Rijswijk
Country
Netherlands
Facility Name
Research Site
City
Roelofarendsveen
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Cebu City
Country
Philippines
Facility Name
Research Site
City
Makati
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Marikina City
Country
Philippines
Facility Name
Research Site
City
Pasig City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Katowice
State/Province
Ochojec
Country
Poland
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Olsztyn
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Radom
Country
Poland
Facility Name
Research Site
City
Rzeszow
Country
Poland
Facility Name
Research Site
City
Sopot
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Toruñ
Country
Poland
Facility Name
Research Site
City
Tychy
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Zielona Gora
Country
Poland
Facility Name
Research Site
City
Almada
Country
Portugal
Facility Name
Research Site
City
Amadora
Country
Portugal
Facility Name
Research Site
City
Elvas
Country
Portugal
Facility Name
Research Site
City
Lisbon
Country
Portugal
Facility Name
Research Site
City
Portalegre
Country
Portugal
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Singapore
Country
Singapore
Facility Name
Research Site
City
Dolny Kubin
Country
Slovakia
Facility Name
Research Site
City
Levice
Country
Slovakia
Facility Name
Research Site
City
Lubochna
Country
Slovakia
Facility Name
Research Site
City
Lucenec
Country
Slovakia
Facility Name
Research Site
City
Nove Zamky
Country
Slovakia
Facility Name
Research Site
City
Povazska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Sahy
Country
Slovakia
Facility Name
Research Site
City
Trencin
Country
Slovakia
Facility Name
Research Site
City
Velky Meder
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Chatsworth
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Gauteng
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Bern
Country
Switzerland
Facility Name
Research Site
City
Ilanz
Country
Switzerland
Facility Name
Research Site
City
Lausanne
Country
Switzerland
Facility Name
Research Site
City
Monthey
Country
Switzerland
Facility Name
Research Site
City
Zürich
Country
Switzerland
Facility Name
Research Site
City
Aberdeen
Country
United Kingdom
Facility Name
Research Site
City
Atherstone
Country
United Kingdom
Facility Name
Research Site
City
Ayr
Country
United Kingdom
Facility Name
Research Site
City
Bath
Country
United Kingdom
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Berks
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Bolton
Country
United Kingdom
Facility Name
Research Site
City
Bucks
Country
United Kingdom
Facility Name
Research Site
City
Cardiff
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Dundee
Country
United Kingdom
Facility Name
Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Leeds
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Northampton
Country
United Kingdom
Facility Name
Research Site
City
Plymouth
Country
United Kingdom
Facility Name
Research Site
City
Radstock
Country
United Kingdom
Facility Name
Research Site
City
Shrewsbury
Country
United Kingdom
Facility Name
Research Site
City
Surrey
Country
United Kingdom
Facility Name
Research Site
City
West Bromwich
Country
United Kingdom
Facility Name
Research Site
City
Wiltshire
Country
United Kingdom
Facility Name
Research Site
City
Wrexham
Country
United Kingdom
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes
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