GALLANT 6 Tesaglitazar vs. Pioglitazone

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00214565
• Other study ID #: D6160C00030
• Status: Terminated
• Phase: Phase 3
• First received: September 20, 2005
• Last updated: November 17, 2010
• Start date: August 2004
• Est. completion date: October 2006

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1450
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Galida

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Finland,  Mexico,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary	The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Secondary	Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Secondary	Lipid parameters
Secondary	FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Secondary	Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
Secondary	Pharmacokinetics of tesaglitazar
Secondary	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
Secondary	Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Secondary	Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).