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GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tesaglitazar
Metformin
Fenofibrate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 the normal range 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

The change in HDL-C from baseline to the end of the randomized treatment period.

Secondary Outcome Measures

Changes in the following variables from baseline to the end of the randomized treatment period:
Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
Central obesity (waist/hip ratio)
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

Full Information

First Posted
December 1, 2005
Last Updated
April 21, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00261352
Brief Title
GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate
Official Title
A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
The development program has been terminated
Study Start Date
March 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 study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)

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
1000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tesaglitazar
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Primary Outcome Measure Information:
Title
The change in HDL-C from baseline to the end of the randomized treatment period.
Secondary Outcome Measure Information:
Title
Changes in the following variables from baseline to the end of the randomized treatment period:
Title
Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
Title
Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
Title
The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
Title
Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
Title
Central obesity (waist/hip ratio)
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

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 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 the normal range 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:
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Research Site
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Fortaleza
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CE
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Brazil
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Goiânia
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GO
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Brazil
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Porto Alegre
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RS
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Brazil
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Curitiba
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Brazil
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Sao Paulo
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Brazil
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Calgary
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Alberta
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Canada
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Surrey
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Canada
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Bay Roberts
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Newfoundland and Labrador
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Canada
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Mount Pearl
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Newfoundland and Labrador
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Canada
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St. John's
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Newfoundland and Labrador
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Canada
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Bolton
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Ontario
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Canada
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Brampton
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Ontario
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Canada
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Etobicoke
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Ontario
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Canada
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Hastings
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Ontario
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Canada
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Kingston
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Ontario
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Canada
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Kitchener
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Ontario
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Canada
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London
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Canada
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Mississauga
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Ontario
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Canada
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Napanee
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Ontario
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Canada
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Newboro
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Canada
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Ottawa
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Ontario
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Canada
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Montreal
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Quebec
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Canada
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Pointe-Claire
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Quebec
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Canada
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Sherbrooke
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Quebec
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Canada
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Helsinki
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Finland
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Kuopio
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Finland
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Lahti
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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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Porvoo
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Finland
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Savonlinna
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Finland
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Seinäjoki
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Finland
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Suonenjoki
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Finland
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Tampere
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Finland
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Turku
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Finland
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Vaasa
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Finland
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Aix En Provence
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France
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France
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Beziers
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France
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France
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Broglie
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France
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France
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Cremeaux
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France
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Falaise
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France
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Fontaine Saint Martin
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France
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Freyming Merlebach
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France
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GAN
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France
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Hyeres
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France
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Jarny
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France
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Jort
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France
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L'aigle
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France
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Lambersart
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France
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Le Lavandou
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France
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Lille
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Lomme Cedex
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France
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France
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Montbrison
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Montpellier
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France
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Moutiers
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Nantes Cedex 01
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France
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Nantes Cedex 1
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France
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Paris
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France
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Poitiers
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Roanne
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France
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France
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Rugles
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France
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Saint Chamond
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France
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Saint Jean de Luz
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France
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Tantonville
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France
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Heidelberg
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Baden-Württemberg
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Germany
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Stuttgart
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Germany
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Düsseldorf
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Germany
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Münster
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Germany
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Germany
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Aschaffenburg
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Germany
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Beckum
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Germany
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Berlin
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Germany
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Germany
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Germany
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Essen
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Gelnhausen
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Germany
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Hannover
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Heidelberg
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Germany
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Heilbronn
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Germany
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Künzing
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Germany
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Nürnberg
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Germany
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Pirna
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Germany
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Hong Kong
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Hong Kong
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Shatin
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Hong Kong
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Balatonfüred
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Hungary
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Budapest
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Hungary
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Gy¿r
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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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Miskolc
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Hungary
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Siófok
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Hungary
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Székesfehérvár
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Hungary
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Mumbai
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Mashatra
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India
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Bangalore
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India
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Delhi
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India
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India
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India
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Jakarta
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DKI Jakarta
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Indonesia
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Malang
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East Java
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Indonesia
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Kuala Lumpur
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Malaysia
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Penang
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Malaysia
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Petaling Jaya
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Malaysia
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Bergen
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Norway
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Bodø
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Norway
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Elverum
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Norway
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Fredrikstad
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Norway
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Hamar
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Norway
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Oslo
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Norway
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Paradis
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Norway
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Trondheim
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Norway
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Tvedestrand
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Norway
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Cebu City
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Philippines
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Makati City
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Philippines
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Manila
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Philippines
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Almada
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Portugal
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Amadora
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Portugal
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Caldas da Rainha
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Portugal
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Elvas
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Portugal
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Lisboa
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Portugal
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Portalegre
Country
Portugal
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Moscow
Country
Russian Federation
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St.Petersburg
Country
Russian Federation
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Yaroslavl
Country
Russian Federation
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Singapore
Country
Singapore
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Pretoria
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South Africa
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Bern
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Switzerland
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Chur
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Switzerland
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Ilanz
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Switzerland
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Lausanne
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Switzerland
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Monthey
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Switzerland
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Sion
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Switzerland
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Zürich
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Switzerland
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Yong-Kang City
State/Province
Tainan County
Country
Taiwan
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Changhua
Country
Taiwan
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Taichung
Country
Taiwan
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Taipei
Country
Taiwan

12. IPD Sharing Statement

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GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

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