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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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.
Secondary ID [1] 0 0
GALLEX 1
Secondary ID [2] 0 0
D6160C00038
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tesaglitazar

Treatment: Drugs: tesaglitazar
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Secondary outcome [3] 0 0
C-reactive protein
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Central obesity (waist circumference, hip circumference, waist/hip ratio)
Timepoint [4] 0 0

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Brisbane
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Research Site - Cairns
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Research Site - Geelong
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Research Site - Melbourne
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Research Site - Perth
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Research Site - Sydney
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Research Site - Tasmania
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- Adelaide
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- Brisbane
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- Cairns
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- Geelong
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- Melbourne
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- Perth
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- Sydney
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- Tasmania
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00252876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Galida Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00252876