GALLANT 8 Tesaglitazar Add-on to Metformin

Type 2 Diabetes Clinical Trial

Official title:

A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Metformin Alone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00251953
• Other study ID #: D6160C00031
• Secondary ID: EudraCT No 2004-
• Status: Terminated
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: April 21, 2009
• Start date: July 2004
• Est. completion date: March 2006

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week 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: 555
• Est. completion date: March 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 >=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 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
• Type 2 Diabetes

Intervention

Drug:
• Tesaglitazar

• Metformin

Locations

Country	Name	City	State
Australia	Research Site	Adelaide
Australia	Research Site	Brisbane
Australia	Research Site	Cairns
Australia	Research Site	Geelong
Australia	Research Site	Melbourne
Australia	Research Site	Perth
Australia	Research Site	Sydney
Canada	Research Site	Chomedey-Laval	Quebec
Canada	Research Site	Coquitlam	British Columbia
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Hastings	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Laval	Quebec
Canada	Research Site	Montréal	Quebec
Canada	Research Site	North York	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Smith Falls	Ontario
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
Finland	Research Site	Hämeenlinna
Finland	Research Site	Helsinki
Finland	Research Site	Joensuu
Finland	Research Site	Kouvola
Finland	Research Site	Kuopio
Finland	Research Site	Mikkeli
Finland	Research Site	Oulu
Finland	Research Site	Salo
Finland	Research Site	Tampere
Finland	Research Site	Vantaa
Germany	Research Site	Aschaffenburg
Germany	Research Site	Berlin
Germany	Research Site	Essen
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg
Germany	Research Site	Mannheim
Germany	Research Site	Nürberg
Germany	Research Site	Rotenburg/Fulda
India	Research Site	Bangalore
India	Research Site	Hyderabad
India	Research Site	New Delhi
Italy	Research Site	Arenzano
Italy	Research Site	Chiavari (GE)
Italy	Research Site	Chieri
Italy	Research Site	Desio
Italy	Research Site	Firenze
Italy	Research Site	Gubbio
Italy	Research Site	Marsala
Italy	Research Site	Messina
Italy	Research Site	Milano
Italy	Research Site	Monteccio Emilia
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Perugia
Italy	Research Site	Pescara
Italy	Research Site	Piacenza
Italy	Research Site	Pistoia
Italy	Research Site	Reggio Calabria
Italy	Research Site	Reggio Emilia
Italy	Research Site	Rho
Italy	Research Site	Roma
Italy	Research Site	Scandiano
Italy	Research Site	Udine
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kubang Kerian	Kota Bharu
Philippines	Research Site	Cebu City
Philippines	Research Site	Quezon City
Singapore	Research Site	Singapore
Sweden	Research Site	Ängelholm
Sweden	Research Site	Borås
Sweden	Research Site	Dalby
Sweden	Research Site	Göteborg
Sweden	Research Site	Höganäs
Sweden	Research Site	Kungsör
Sweden	Research Site	Malmö
Sweden	Research Site	Mölndal
Sweden	Research Site	Oskarshamn
Sweden	Research Site	Skene
Sweden	Research Site	Skrivarp
Sweden	Research Site	Stenungsund
Sweden	Research Site	Uppsala
United Kingdom	Research Site	Aberdeen
United Kingdom	Research Site	Aldershot
United Kingdom	Research Site	Atherstone
United Kingdom	Research Site	Barry
United Kingdom	Research Site	Bath
United Kingdom	Research Site	Bexhill-on-Sea
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Bolton
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Chippenham
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Harrow
United Kingdom	Research Site	Hastings
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Radstock
United Kingdom	Research Site	Slough
United Kingdom	Research Site	Swindon
United Kingdom	Research Site	West Midlands
United Kingdom	Research Site	Wrexham

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Canada,  Finland,  Germany,  India,  Italy,  Malaysia,  Philippines,  Singapore,  Sweden,  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	Changes in the following variables from baseline to the end of the randomized treatment period:
Secondary	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 (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 c
Secondary	C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Secondary	FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Secondary	Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Secondary	Fibrinogen
Secondary	Urinary albumin excretion
Secondary	Waist/hip ratio
Secondary	Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
Secondary	Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
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