Clinical trial NCT00214565: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary outcomes:
measure: The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
measure: Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
measure: Lipid parameters
measure: FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
measure: Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
measure: Pharmacokinetics of tesaglitazar
measure: 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
measure: Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
measure: Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).
Other outcomes:
Locations:
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Córdoba
country: Argentina
facility: Research Site
city: Moron- Buenos Aires
country: Argentina
facility: Research Site
city: Quilmes - Buenos Aires
country: Argentina
facility: Research Sites
city: Rosario
country: Argentina
facility: Research Site
city: Salta
country: Argentina
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Abbotsford
country: Canada
facility: Research Site
state: British Columbia
city: Chilliwack
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Dartmouth
country: Canada
facility: Research Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Truro
country: Canada
facility: Research Site
state: Nova Scotia
city: Windsor
country: Canada
facility: Research Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: St. Catharines
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Trois-Rivières
country: Canada
facility: Research Site
state: Quebec
city: Chicoutimi
country: Canada
facility: Research Site
city: Longueuil
country: Canada
facility: Research Site
city: Montreal
country: Canada
facility: Research Site
city: St. John's
country: Canada
facility: Research Site
city: Espoo
country: Finland
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Pietarsaar
country: Finland
facility: Research Site
city: Pori
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Guadalajara Jalisco
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Nuevo Leon
country: Mexico
facility: Research Site
city: Puebla
country: Mexico
facility: Research Site
city: Torreon
country: Mexico
facility: Research Site
city: Zapopan
country: Mexico
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Elvernum
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Horten
country: Norway
facility: Research Site
city: Kongsberg
country: Norway
facility: Research Site
city: Lena
country: Norway
facility: Research Site
city: Loeten
country: Norway
facility: Research Site
city: Lysaker
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Osteraas
country: Norway
facility: Research Site
city: Skedsmokorset
country: Norway
facility: Research Site
city: Straume
country: Norway
facility: Research Site
city: Toensberg
country: Norway
facility: Research Site
city: Tronheim
country: Norway
facility: Research Site
city: Ås
country: Norway
facility: Research Site
city: Dublin
country: United Kingdom
facility: Research Site
state: Ireland
city: Wexford
country: United Kingdom
facility: Research Site
state: Ireland
city: Antrim
country: United Kingdom
facility: Research Site
state: NI
city: Belfast
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Kent
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Mid Glamorgan
country: United Kingdom
facility: Research Site
city: Pembrokeshire
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research SIte
city: Surrey
country: United Kingdom
facility: Research Site
city: Wiltshire
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: