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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/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
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
Secondary ID [1] 0 0
EudraCT No 2004-000348-25
Secondary ID [2] 0 0
D6160C00031
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 - Metformin

Treatment: Drugs: Tesaglitazar


Treatment: Drugs: Metformin
Intervention code [1] 0 0
Treatment: Drugs
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
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

- 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
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
Terminated
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 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 outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
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Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Finland
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Helsinki
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Finland
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Hämeenlinna
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Finland
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Joensuu
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Finland
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Kouvola
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Finland
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Kuopio
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Finland
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Mikkeli
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Finland
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Oulu
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Finland
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Salo
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Finland
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Tampere
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Finland
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Vantaa
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Germany
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Aschaffenburg
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Germany
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Berlin
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Mannheim
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Germany
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Nürberg
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Germany
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Rotenburg/Fulda
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India
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Bangalore
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India
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Hyderabad
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India
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New Delhi
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Italy
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Arenzano
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Italy
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Chiavari (GE)
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Italy
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Chieri
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Italy
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Desio
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Italy
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Firenze
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Gubbio
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Marsala
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Messina
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Milano
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Italy
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Monteccio Emilia
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Napoli
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Padova
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Pescara
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Piacenza
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Pistoia
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Reggio Emilia
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Scandiano
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Höganäs
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Kungsör
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Malmö
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Mölndal
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Oskarshamn
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Skene
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Skrivarp
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Stenungsund
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Uppsala
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Sweden
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Ängelholm
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United Kingdom
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Aberdeen
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Aldershot
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Atherstone
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Barry
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Bath
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Bexhill-on-Sea
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Birmingham
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Bolton
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Cardiff
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Chippenham
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Coventry
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Dundee
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Edinburgh
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Glasgow
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Harrow
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Hastings
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Leeds
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Liverpool
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Manchester
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Plymouth
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Radstock
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Slough
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United Kingdom
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Swindon
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United Kingdom
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West Midlands
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Wrexham

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

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00251953
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/NCT00251953