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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00251953
Registration number
NCT00251953
Ethics application status
Date submitted
9/11/2005
Date registered
11/11/2005
Date last updated
22/04/2009
Titles & IDs
Public title
GALLANT 8 Tesaglitazar Add-on to Metformin
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Scientific title
A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Metformin Alone
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Secondary ID [1]
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EudraCT No 2004-000348-25
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Secondary ID [2]
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0
D6160C00031
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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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0
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Condition category
Condition code
Metabolic and Endocrine
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0
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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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Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Changes in the following variables from baseline to the end of the randomized treatment period:
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and c
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Tumor necrosis factor-alpha, intracellular adhesion molecule-1
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Assessment method [7]
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Timepoint [7]
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Secondary outcome [8]
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Fibrinogen
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Assessment method [8]
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Timepoint [8]
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Secondary outcome [9]
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Urinary albumin excretion
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Assessment method [9]
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Timepoint [9]
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Secondary outcome [10]
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Waist/hip ratio
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Assessment method [10]
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Timepoint [10]
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Secondary outcome [11]
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Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
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Assessment method [11]
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Timepoint [11]
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Secondary outcome [12]
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Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
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Assessment method [12]
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Timepoint [12]
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Secondary outcome [13]
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Pharmacokinetics of tesaglitazar
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Assessment method [13]
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Timepoint [13]
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Secondary outcome [14]
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Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
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Assessment method [14]
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Timepoint [14]
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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
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
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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
* Received any investigational product in other clinical studies within 12 weeks
* 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
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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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
1/07/2004
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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
1/03/2006
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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
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Adelaide
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Research Site - Brisbane
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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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- 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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Recruitment postcode(s) [7]
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- Sydney
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Ontario
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Joensuu
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Kouvola
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Kuopio
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Mikkeli
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Oulu
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Salo
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Tampere
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Wrexham
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period
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Trial website
https://clinicaltrials.gov/study/NCT00251953
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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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AstraZeneca Galida Medical Science Director, MD
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Address
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AstraZeneca
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Contact person for public queries
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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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00251953
Download to PDF