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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00252876
Registration number
NCT00252876
Ethics application status
Date submitted
10/11/2005
Date registered
15/11/2005
Date last updated
17/03/2008
Titles & IDs
Public title
GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes
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Scientific 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.
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Secondary ID [1]
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GALLEX 1
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Secondary ID [2]
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D6160C00038
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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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)
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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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
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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C-reactive protein
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Secondary outcome [4]
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Central obesity (waist circumference, hip circumference, waist/hip ratio)
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Assessment method [4]
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Timepoint [4]
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2007
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
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Research Site - Adelaide
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- Adelaide
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- Brisbane
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Deurne
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Netherlands
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Huizen
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Netherlands
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Losser
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Netherlands
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Nijverdal
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Netherlands
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Rijswijk
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Netherlands
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Roelofarendsveen
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Netherlands
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Rotterdam
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Philippines
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Cebu City
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Makati
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Philippines
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Manila
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Philippines
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Marikina City
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Philippines
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Pasig City
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Philippines
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Quezon City
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Poland
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Ochojec
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Poland
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Bialystok
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Bydgoszcz
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Krakow
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Lodz
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Olsztyn
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Poznan
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Radom
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Rzeszow
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Sopot
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Szczecin
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Toruñ
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Tychy
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Zielona Gora
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Portugal
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Almada
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Portugal
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Amadora
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Portugal
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Elvas
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Portugal
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Lisbon
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Moscow
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Singapore
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Dolny Kubin
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Levice
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Lubochna
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Lucenec
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Nove Zamky
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Povazska Bystrica
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Sahy
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Trencin
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Velky Meder
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Zilina
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Durban
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Gauteng
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Johannesburg
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Pretoria
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Bern
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Switzerland
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Ilanz
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Switzerland
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Lausanne
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Monthey
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Zürich
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Aberdeen
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Atherstone
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Ayr
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Bath
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Edinburgh
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Glasgow
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Manchester
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Northampton
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Radstock
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Hanoi
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Vietnam
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00252876
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
AstraZeneca Galida Medical Science Director, MD
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Address
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT00252876
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