Clinical trial NCT00255541: GALLANT 4 Tesaglitazar vs. Glibenclamide
Official title: A 52-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 580
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 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (glibenclamide) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week double blind treatment period and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.


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: 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 (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: Antwerpen
country: Belgium
facility: Research Site
city: Braine-L'alleud
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Merksem
country: Belgium
facility: Research Site
city: Sint-Gillis-Waas
country: Belgium
facility: Research Site
city: Steenokkerzeel
country: Belgium
facility: Research Site
city: Shatin, N.T.
country: Hong Kong
facility: Research Site
city: Balatonfüred
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Kaposvár
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
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: Gubbio (PG)
country: Italy
facility: Research Site
city: Milano
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: Piacenza
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: Udine
country: Italy
facility: Research Site
city: Kubang Kerian
country: Malaysia
facility: Research Site
state: Kota Bharu
city: Kuala Lampur
country: Malaysia
facility: Research Site
city: México
country: Mexico
facility: Research Site
state: D.f.
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Veracruz
country: Mexico
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Kongsvinger
country: Norway
facility: Research Site
city: Lysaker
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Skedsmokorset
country: Norway
facility: Research Site
city: Sørumstand
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Ås
country: Norway
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Pasig City
country: Philippines
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: P³ock
country: Poland
facility: Research Site
city: Toruñ
country: Poland
facility: Research Site
city: Tychy
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: £ód?
country: Poland
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Ilava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kysucke Nove Mesto
country: Slovakia
facility: Research Site
city: Lubochna
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Houghton Gauteng
country: South Africa
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: