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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/NCT00252837




Registration number
NCT00252837
Ethics application status
Date submitted
10/11/2005
Date registered
15/11/2005
Date last updated
17/03/2008

Titles & IDs
Public title
GALLANT 22 Tesaglitazar vs. Placebo
Scientific title
A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes
Secondary ID [1] 0 0
EudraCT No 2004-004374-90
Secondary ID [2] 0 0
D6160C00055
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
Behaviour - Dietary and Lifestyle counseling

Treatment: Drugs: Tesaglitazar


Behaviour: Dietary and Lifestyle counseling
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Behaviour
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
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 [2] 0 0
Secondary outcome [3] 0 0
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Fibrinogen
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Proportion of patients with microalbuminuria
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Waist/hip ratio
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Timepoint [10] 0 0
Secondary outcome [11] 0 0
Pharmacokinetics of tesaglitazar
Timepoint [11] 0 0
Secondary outcome [12] 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 [12] 0 0
Secondary outcome [13] 0 0
Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Timepoint [13] 0 0
Secondary outcome [14] 0 0
Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.
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

- Drug-naïve (ie, no use of antidiabetic drug[s], for at least 24 weeks prior to visit
1).
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
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
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 - Cairns
Recruitment hospital [3] 0 0
Research Site - Gosford
Recruitment hospital [4] 0 0
Research Site - Keswick
Recruitment hospital [5] 0 0
Research Site - Kippa Ring
Recruitment hospital [6] 0 0
Research Site - Melbourne
Recruitment hospital [7] 0 0
Research Site - Miranda
Recruitment hospital [8] 0 0
Research Site - Nowra
Recruitment hospital [9] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Cairns
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- Keswick
Recruitment postcode(s) [5] 0 0
- Kippa Ring
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Miranda
Recruitment postcode(s) [8] 0 0
- Nowra
Recruitment postcode(s) [9] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Brno
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Hodonin
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Hradec Kralove
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Plzen
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Praha 5
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Pribram
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Semily
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Tabor
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Usti nad Labem
Country [10] 0 0
Estonia
State/province [10] 0 0
Paide
Country [11] 0 0
Estonia
State/province [11] 0 0
Pärnu
Country [12] 0 0
Estonia
State/province [12] 0 0
Tallinn
Country [13] 0 0
Estonia
State/province [13] 0 0
Tartu
Country [14] 0 0
Estonia
State/province [14] 0 0
Viljandi
Country [15] 0 0
Former Serbia and Montenegro
State/province [15] 0 0
Belgrade
Country [16] 0 0
France
State/province [16] 0 0
Angers
Country [17] 0 0
France
State/province [17] 0 0
Briollay
Country [18] 0 0
France
State/province [18] 0 0
Poitiers
Country [19] 0 0
France
State/province [19] 0 0
Saint Benoit
Country [20] 0 0
France
State/province [20] 0 0
Saint Ouen
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
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France
State/province [22] 0 0
Trelaze
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Greece
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Athens
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Greece
State/province [24] 0 0
Piraeus
Country [25] 0 0
Hungary
State/province [25] 0 0
Balatonfüred
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Kaposvár
Country [28] 0 0
Hungary
State/province [28] 0 0
Kecskemét
Country [29] 0 0
Hungary
State/province [29] 0 0
Székesfehérvár
Country [30] 0 0
Latvia
State/province [30] 0 0
Daugavpils
Country [31] 0 0
Latvia
State/province [31] 0 0
Jekabpils
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Latvia
State/province [32] 0 0
Madona
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Latvia
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Riga
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Latvia
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SIgulda
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Latvia
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Talsi
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Latvia
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Valmiera
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Panevezys
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Lithuania
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Vilnius
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Norway
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Aurskog
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Norway
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Bergen
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Norway
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Enebakk
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Norway
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Fredrikstad
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Norway
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Haugesund
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Norway
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Hønefoss
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Norway
State/province [47] 0 0
Inderøy
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Norway
State/province [48] 0 0
Larvik
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Norway
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Lierskogen
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Norway
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Oslo
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Norway
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Rolvsøy
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Philippines
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Cebu 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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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Krakow
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Lodz
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Lublin
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Olsztyn
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Poland
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Poznan
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Poland
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Radom
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Rzeszow
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Poland
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Sopot
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Szczecin
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Toruñ
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Tychy
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Warszawa
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Wroclaw
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Poland
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Zabrze
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Poland
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Zielona Gora
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Slovakia
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Dolny Kubin
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Slovakia
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Levice
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Slovakia
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Lubochna
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Slovakia
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Lucenec
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Slovakia
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Nove Zamky
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Slovakia
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Povazska Bystrica
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Slovakia
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Sahy
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Slovakia
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Trencin
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Slovakia
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Velky Meder
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Slovakia
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Zilina
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Sweden
State/province [84] 0 0
Borås
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Sweden
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Göteborg
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Sweden
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Mölndal
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Sweden
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Partille
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Sweden
State/province [88] 0 0
Skene
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Sweden
State/province [89] 0 0
Stenungsund
Country [90] 0 0
Sweden
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Uddevalla
Country [91] 0 0
Sweden
State/province [91] 0 0
Vänersborg
Country [92] 0 0
Sweden
State/province [92] 0 0
Åmål

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 and 1 mg) in patients with type 2 diabetes, not adequately
controlled on diet and lifestyle advice alone during the run-in period. The study comprises a
6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week
follow-up period.

The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT
2 will be transferred to the GALLANT 22 database and will be analyzed together with the data
from GALLANT 22 clinical study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00252837
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/NCT00252837