Clinical trial NCT00251953: GALLANT 8 Tesaglitazar Add-on to Metformin
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 555
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, 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


Eligibility criteria: 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

Primary outcomes:
measure: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary outcomes:
measure: Changes in the following variables from baseline to the end of the randomized treatment period:
measure: 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 (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
measure: C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
measure: FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
measure: Tumor necrosis factor-alpha, intracellular adhesion molecule-1
measure: Fibrinogen
measure: Urinary albumin excretion
measure: Waist/hip ratio
measure: Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
measure: Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
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
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Research Site
city: Brisbane
country: Australia
facility: Research Site
city: Cairns
country: Australia
facility: Research Site
city: Geelong
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Perth
country: Australia
facility: Research Site
city: Sydney
country: Australia
facility: Research Site
city: Coquitlam
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Hastings
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Smith Falls
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Chomedey-Laval
country: Canada
facility: Research Site
state: Quebec
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montréal
country: Canada
facility: Research Site
state: Quebec
city: Helsinki
country: Finland
facility: Research Site
city: Hämeenlinna
country: Finland
facility: Research Site
city: Joensuu
country: Finland
facility: Research Site
city: Kouvola
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Mikkeli
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Salo
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Vantaa
country: Finland
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Nürberg
country: Germany
facility: Research Site
city: Rotenburg/Fulda
country: Germany
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Arenzano
country: Italy
facility: Research Site
city: Chiavari (GE)
country: Italy
facility: Research Site
city: Chieri
country: Italy
facility: Research Site
city: Desio
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Gubbio
country: Italy
facility: Research Site
city: Marsala
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Monteccio Emilia
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Pescara
country: Italy
facility: Research Site
city: Piacenza
country: Italy
facility: Research Site
city: Pistoia
country: Italy
facility: Research Site
city: Reggio Calabria
country: Italy
facility: Research Site
city: Reggio Emilia
country: Italy
facility: Research Site
city: Rho
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Scandiano
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Kubang Kerian
country: Malaysia
facility: Research Site
state: Kota Bharu
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Borås
country: Sweden
facility: Research Site
city: Dalby
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Höganäs
country: Sweden
facility: Research Site
city: Kungsör
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Mölndal
country: Sweden
facility: Research Site
city: Oskarshamn
country: Sweden
facility: Research Site
city: Skene
country: Sweden
facility: Research Site
city: Skrivarp
country: Sweden
facility: Research Site
city: Stenungsund
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Ängelholm
country: Sweden
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Aldershot
country: United Kingdom
facility: Research Site
city: Atherstone
country: United Kingdom
facility: Research Site
city: Barry
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Bexhill-on-Sea
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Chippenham
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: Hastings
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Radstock
country: United Kingdom
facility: Research Site
city: Slough
country: United Kingdom
facility: Research Site
city: Swindon
country: United Kingdom
facility: Research Site
city: West Midlands
country: United Kingdom
facility: Research Site
city: Wrexham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: