Back to resultsGALLANT 22 Tesaglitazar vs. Placebo
Primary Purpose
Type 2 Diabetes
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tesaglitazar
Dietary and Lifestyle counseling
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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). 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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Outcomes
Primary Outcome Measures
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary Outcome Measures
Changes in the following variables from baseline to the end of the randomized treatment period:
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
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Fibrinogen
Proportion of patients with microalbuminuria
Waist/hip ratio
Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Pharmacokinetics of tesaglitazar
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
Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00252837
Brief Title
GALLANT 22 Tesaglitazar vs. Placebo
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
The development program has been terminated
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
475 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tesaglitazar
Intervention Type
Behavioral
Intervention Name(s)
Dietary and Lifestyle counseling
Primary Outcome Measure Information:
Title
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary Outcome Measure Information:
Title
Changes in the following variables from baseline to the end of the randomized treatment period:
Title
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
Title
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Title
Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
Title
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Title
Fibrinogen
Title
Proportion of patients with microalbuminuria
Title
Waist/hip ratio
Title
Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
Title
Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Title
Pharmacokinetics of tesaglitazar
Title
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
Title
Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Title
Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Galida Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Adelaide
Country
Australia
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City
Cairns
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Australia
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Gosford
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Australia
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Keswick
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Australia
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Kippa Ring
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Australia
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Melbourne
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Australia
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Miranda
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Australia
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Nowra
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Australia
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Wollongong
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Australia
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Brno
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Czech Republic
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Hodonin
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Czech Republic
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Hradec Kralove
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Czech Republic
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Plzen
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Czech Republic
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Praha 5
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Czech Republic
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Pribram
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Czech Republic
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Semily
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Czech Republic
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Tabor
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Czech Republic
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Usti nad Labem
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Czech Republic
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Paide
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Estonia
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Pärnu
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Estonia
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Tallinn
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Estonia
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Tartu
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Estonia
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Viljandi
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Estonia
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Belgrade
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Former Serbia and Montenegro
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Angers
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France
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Briollay
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France
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Poitiers
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France
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Saint Benoit
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France
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Saint Ouen
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France
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Toulouse
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France
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Trelaze
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France
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Athens
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Greece
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Piraeus
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Greece
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Balatonfüred
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Hungary
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Budapest
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Hungary
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Kaposvár
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Hungary
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Kecskemét
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Hungary
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Székesfehérvár
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Hungary
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Daugavpils
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Latvia
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Jekabpils
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Latvia
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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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Latvia
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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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Lithuania
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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
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Inderøy
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Norway
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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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Norway
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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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Philippines
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Katowice
State/Province
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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Poland
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Lodz
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Poland
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Lublin
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Poland
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Olsztyn
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Poland
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Poznań
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Poland
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Radom
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Poland
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Rzeszow
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Poland
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Sopot
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Poland
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Szczecin
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Poland
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Toruñ
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Poland
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Tychy
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Poland
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Warszawa
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Poland
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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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Poland
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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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Slovakia
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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
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Skene
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Sweden
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Stenungsund
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Sweden
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Uddevalla
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Sweden
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Vänersborg
Country
Sweden
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Åmål
Country
Sweden
12. IPD Sharing Statement
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GALLANT 22 Tesaglitazar vs. Placebo
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