Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00251940




Registration number
NCT00251940
Ethics application status
Date submitted
9/11/2005
Date registered
11/11/2005
Date last updated
17/03/2008

Titles & IDs
Public title
GALLANT 7 Tesaglitazar Add-on to Sulphonylurea
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 Sulphonylurea Alone
Secondary ID [1] 0 0
EudraCT No 2004-001144-71
Secondary ID [2] 0 0
D6160C00032
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Changes in the following variables from baseline to the end of the randomized treatment period:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
• The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Timepoint [2] 0 0
Secondary outcome [3] 0 0
• Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Timepoint [3] 0 0
Secondary outcome [4] 0 0
• 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
Timepoint [4] 0 0
Secondary outcome [5] 0 0
• C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Timepoint [5] 0 0
Secondary outcome [6] 0 0
• FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Timepoint [6] 0 0
Secondary outcome [7] 0 0
• Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Timepoint [7] 0 0
Secondary outcome [8] 0 0
• Fibrinogen
Timepoint [8] 0 0
Secondary outcome [9] 0 0
• Urinary albumin excretion
Timepoint [9] 0 0
Secondary outcome [10] 0 0
• Waist/hip ratio
Timepoint [10] 0 0
Secondary outcome [11] 0 0
• Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
Timepoint [11] 0 0
Secondary outcome [12] 0 0
• Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Timepoint [12] 0 0
Secondary outcome [13] 0 0
• Pharmacokinetics of tesaglitazar
Timepoint [13] 0 0
Secondary outcome [14] 0 0
• 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
Timepoint [14] 0 0

Eligibility
Key inclusion criteria
* Provision of a written informed consent
* 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
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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
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
Recruitment hospital [3] 0 0
Research Site - Cairns
Recruitment hospital [4] 0 0
Research Site - Geelong
Recruitment hospital [5] 0 0
Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Perth
Recruitment hospital [7] 0 0
Research Site - Sydney
Recruitment hospital [8] 0 0
Research Site - Tasmania
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Cairns
Recruitment postcode(s) [4] 0 0
- Geelong
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment postcode(s) [8] 0 0
- Tasmania
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Angers
Country [2] 0 0
France
State/province [2] 0 0
Hyeres
Country [3] 0 0
France
State/province [3] 0 0
La Garde
Country [4] 0 0
France
State/province [4] 0 0
La Seyne Sur Mer
Country [5] 0 0
France
State/province [5] 0 0
Laval
Country [6] 0 0
France
State/province [6] 0 0
Le Brusc
Country [7] 0 0
France
State/province [7] 0 0
Le Lavandou
Country [8] 0 0
France
State/province [8] 0 0
Montrevault
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Saint-Cyr
Country [11] 0 0
France
State/province [11] 0 0
Six Fours Les Plages
Country [12] 0 0
France
State/province [12] 0 0
Tierce
Country [13] 0 0
France
State/province [13] 0 0
Toulon
Country [14] 0 0
Israel
State/province [14] 0 0
Ashkelon
Country [15] 0 0
Israel
State/province [15] 0 0
Haifa
Country [16] 0 0
Israel
State/province [16] 0 0
Holon
Country [17] 0 0
Israel
State/province [17] 0 0
Jerusalem
Country [18] 0 0
Israel
State/province [18] 0 0
Rishon-Lezion
Country [19] 0 0
Israel
State/province [19] 0 0
Tel Aviv
Country [20] 0 0
Israel
State/province [20] 0 0
Tel Hashomer
Country [21] 0 0
Israel
State/province [21] 0 0
Zefat
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Suwon
Country [24] 0 0
Norway
State/province [24] 0 0
Bergen
Country [25] 0 0
Norway
State/province [25] 0 0
Elverum
Country [26] 0 0
Norway
State/province [26] 0 0
Enebakk
Country [27] 0 0
Norway
State/province [27] 0 0
Fredrikstad
Country [28] 0 0
Norway
State/province [28] 0 0
Gamle Fredrikstad
Country [29] 0 0
Norway
State/province [29] 0 0
Hamar
Country [30] 0 0
Norway
State/province [30] 0 0
Haugesund
Country [31] 0 0
Norway
State/province [31] 0 0
Hurdal
Country [32] 0 0
Norway
State/province [32] 0 0
Inderøy
Country [33] 0 0
Norway
State/province [33] 0 0
Lena
Country [34] 0 0
Norway
State/province [34] 0 0
Levanger
Country [35] 0 0
Norway
State/province [35] 0 0
Oslo
Country [36] 0 0
Norway
State/province [36] 0 0
Rud
Country [37] 0 0
Norway
State/province [37] 0 0
Sedsmokorset
Country [38] 0 0
Norway
State/province [38] 0 0
Soerumsand
Country [39] 0 0
Norway
State/province [39] 0 0
Stavanger
Country [40] 0 0
Philippines
State/province [40] 0 0
Manila
Country [41] 0 0
Philippines
State/province [41] 0 0
Marikina City
Country [42] 0 0
Philippines
State/province [42] 0 0
Pasig City
Country [43] 0 0
South Africa
State/province [43] 0 0
Cape Town
Country [44] 0 0
South Africa
State/province [44] 0 0
Chatsworth
Country [45] 0 0
South Africa
State/province [45] 0 0
Gauteng
Country [46] 0 0
South Africa
State/province [46] 0 0
Pretoria
Country [47] 0 0
Spain
State/province [47] 0 0
Alzira (Valencia)
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Guissona (Lleida)
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
San Sebastian de los Reyes ( Madrid)
Country [52] 0 0
Spain
State/province [52] 0 0
San Vicente de Raspeig (Alicante)
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Ireland
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Aberdeen
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Barnsley
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Bath
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Belfast
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Birmingham
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Cardiff
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Coventry
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Dundee
Country [63] 0 0
United Kingdom
State/province [63] 0 0
East Sussex
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Edinburgh
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Glasgow
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Leeds
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Liverpool
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Manchester
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Shrewsbury
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Surrey
Country [72] 0 0
United Kingdom
State/province [72] 0 0
West Midlands
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Wiltshire
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Wrexham
Country [75] 0 0
Vietnam
State/province [75] 0 0
Hanoi
Country [76] 0 0
Vietnam
State/province [76] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT00251940