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GALLANT 6 Tesaglitazar vs. Pioglitazone

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
FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
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
Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).

Full Information

First Posted
September 20, 2005
Last Updated
November 17, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00214565
Brief Title
GALLANT 6 Tesaglitazar vs. Pioglitazone
Official Title
A 24-Wk Randomised, Double-Blind, Multi-Centre, Active-Controlled (Pioglitazone) 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
October 2006 (Actual)
Study Completion Date
October 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, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg 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 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.

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
1450 (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
Title
FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Title
Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
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
Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Title
Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).

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:
Facility Name
Research Site
City
Altoona
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Córdoba
Country
Argentina
Facility Name
Research Site
City
Moron- Buenos Aires
Country
Argentina
Facility Name
Research Sites
City
Quilmes - Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Rosario
Country
Argentina
Facility Name
Research Site
City
Salta
Country
Argentina
Facility Name
Research Site
City
Curitiba
Country
Brazil
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Abbotsford
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Chilliwack
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Dartmouth
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Truro
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Niagara Falls
State/Province
Ontario
Country
Canada
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Research Site
City
Oshawa
State/Province
Ontario
Country
Canada
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Research Site
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Scarborough
State/Province
Ontario
Country
Canada
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St. Catharines
State/Province
Ontario
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Canada
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Toronto
State/Province
Ontario
Country
Canada
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Windsor
State/Province
Ontario
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Canada
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Trois-Rivières
State/Province
Quebec
Country
Canada
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Chicoutimi
Country
Canada
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Longueuil
Country
Canada
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Montreal
Country
Canada
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Research Site
City
St. John's
Country
Canada
Facility Name
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City
Espoo
Country
Finland
Facility Name
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City
Helsinki
Country
Finland
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
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City
Pietarsaar
Country
Finland
Facility Name
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City
Pori
Country
Finland
Facility Name
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City
Tampere
Country
Finland
Facility Name
Research Site
City
Guadalajara Jalisco
Country
Mexico
Facility Name
Research Site
City
Mexico City
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Nuevo Leon
Country
Mexico
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Research Site
City
Puebla
Country
Mexico
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Torreon
Country
Mexico
Facility Name
Research Site
City
Zapopan
Country
Mexico
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Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Elvernum
Country
Norway
Facility Name
Research Site
City
Hamar
Country
Norway
Facility Name
Research Site
City
Horten
Country
Norway
Facility Name
Research Site
City
Kongsberg
Country
Norway
Facility Name
Research Site
City
Lena
Country
Norway
Facility Name
Research Site
City
Loeten
Country
Norway
Facility Name
Research Site
City
Lysaker
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Osteraas
Country
Norway
Facility Name
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City
Skedsmokorset
Country
Norway
Facility Name
Research Site
City
Straume
Country
Norway
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City
Toensberg
Country
Norway
Facility Name
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City
Tronheim
Country
Norway
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City
Ås
Country
Norway
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Dublin
State/Province
Ireland
Country
United Kingdom
Facility Name
Research Site
City
Wexford
State/Province
Ireland
Country
United Kingdom
Facility Name
Research Site
City
Antrim
State/Province
NI
Country
United Kingdom
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Cardiff
Country
United Kingdom
Facility Name
Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Kent
Country
United Kingdom
Facility Name
Research Site
City
Leeds
Country
United Kingdom
Facility Name
Research Site
City
Mid Glamorgan
Country
United Kingdom
Facility Name
Research Site
City
Pembrokeshire
Country
United Kingdom
Facility Name
Research Site
City
Plymouth
Country
United Kingdom
Facility Name
Research SIte
City
Reading
Country
United Kingdom
Facility Name
Research Site
City
Surrey
Country
United Kingdom
Facility Name
Research Site
City
Wiltshire
Country
United Kingdom

12. IPD Sharing Statement

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GALLANT 6 Tesaglitazar vs. Pioglitazone

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