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GALLANT 5 Tesaglitazar Versus Metformin

Primary Purpose

Diabetes Mellitus, Type 2

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

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring 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 ³18 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 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

The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
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 co
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Fibrinogen
Urinary albumin excretion
Waist/hip ratio
Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, 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

Full Information

First Posted
September 20, 2005
Last Updated
November 18, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00214591
Brief Title
GALLANT 5 Tesaglitazar Versus Metformin
Official Title
A 52-wk Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin) Study to Evaluate the Efficacy, Safety & Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
The development program has been terminated
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar 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 placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
580 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GALIDA
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
The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Title
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
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 co
Title
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Title
FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Title
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Title
Fibrinogen
Title
Urinary albumin excretion
Title
Waist/hip ratio
Title
Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, 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

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 ³18 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 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:
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Birmingham
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Alabama
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United States
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Columbiana
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Alabama
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United States
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Mobile
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Alabama
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United States
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Carlisle
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Arizona
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United States
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Sherwood
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United States
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Chula Vista
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Escondido
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United States
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Huntington Beach
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United States
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Los Angeles
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United States
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Mission Viejo
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United States
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Orange
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Pasadena
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United States
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Pomona
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Redondo Beach
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Sacramento
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Colorado Springs
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Colorado
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Wheat Ridge
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Clearwater
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Gainesville
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Hollywood
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Jacksonville
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Miami
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West Palm Beach
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Atlanta
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Georgia
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Brunswick
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Carollton
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Honolulu
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Witchita
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Hamilton
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Bronx
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Rochester
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Medford
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Philadelphia
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Lubbock
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Burke
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Norfolk
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Tacoma
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Menomonee Falls
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Milwaukee
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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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Finland
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Aschaffenburg
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Germany
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Bad Segeberg
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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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Dresden
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Germany
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Ehrenberg
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Germany
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Essen
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Germany
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Feldafing
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Hermaringen
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Germany
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Künzing
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Germany
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Langen
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Germany
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Mannheim
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Germany
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Marl
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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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Rotenburg/Fulda
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Germany
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Ashkelon
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Rishon-Lezion
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Israel
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Tel Aviv
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Israel
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Zefat
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Israel
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Beek en Donk
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Netherlands
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Bennebroe
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Netherlands
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Den Haag
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Netherlands
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Deurne
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Netherlands
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Huizen
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Netherlands
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Losser
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Netherlands
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Nijverdal
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Netherlands
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Rijswijk
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Netherlands
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Roelofarendsveen
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Netherlands
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Rotterdam
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Netherlands
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Bergen
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Norway
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Oslo
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Norway
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Østerås
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Norway
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San Vicente de Raspeig
State/Province
Alicante
Country
Spain
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Villar del Arzobispo
State/Province
Valencia
Country
Spain
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Alzira (Valencia)
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Spain
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Barcelona
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Spain
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Begonte (Lugo)
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Aberdeen
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United Kingdom
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Ayr
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United Kingdom
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Bath
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United Kingdom
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Berks
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United Kingdom
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Bucks
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United Kingdom
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Coventry
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United Kingdom
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Dundee
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United Kingdom
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Glasgow
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United Kingdom
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Manchester
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United Kingdom
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Northampton
Country
United Kingdom
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Wiltshire
Country
United Kingdom

12. IPD Sharing Statement

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GALLANT 5 Tesaglitazar Versus Metformin

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