Clinical trial NCT00252837: GALLANT 22 Tesaglitazar vs. Placebo
Official title: A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve 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: 2005-11-15
Enrollment: 475
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 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 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period.

The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.


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
* Drug-naïve (ie, no use of antidiabetic drug\[s\], for at least 24 weeks prior to visit 1).

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: 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: Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
measure: Tumor necrosis factor-alpha, intracellular adhesion molecule-1
measure: Fibrinogen
measure: Proportion of patients with microalbuminuria
measure: Waist/hip ratio
measure: Responder analyses for HbA1c, FPG, TG, HDL C, 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
measure: Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
measure: Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Research Site
city: Cairns
country: Australia
facility: Research Site
city: Gosford
country: Australia
facility: Research Site
city: Keswick
country: Australia
facility: Research Site
city: Kippa Ring
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Miranda
country: Australia
facility: Research Site
city: Nowra
country: Australia
facility: Research Site
city: Wollongong
country: Australia
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Hodonin
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Pribram
country: Czech Republic
facility: Research Site
city: Semily
country: Czech Republic
facility: Research Site
city: Tabor
country: Czech Republic
facility: Research Site
city: Usti nad Labem
country: Czech Republic
facility: Research Site
city: Paide
country: Estonia
facility: Research Site
city: Pärnu
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Viljandi
country: Estonia
facility: Research Site
city: Belgrade
country: Former Serbia and Montenegro
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Briollay
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Saint Benoit
country: France
facility: Research Site
city: Saint Ouen
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Trelaze
country: France
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Piraeus
country: Greece
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: Daugavpils
country: Latvia
facility: Research Site
city: Jekabpils
country: Latvia
facility: Research Site
city: Madona
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: SIgulda
country: Latvia
facility: Research Site
city: Talsi
country: Latvia
facility: Research Site
city: Valmiera
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Panevezys
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Aurskog
country: Norway
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Enebakk
country: Norway
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Haugesund
country: Norway
facility: Research Site
city: Hønefoss
country: Norway
facility: Research Site
city: Inderøy
country: Norway
facility: Research Site
city: Larvik
country: Norway
facility: Research Site
city: Lierskogen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Rolvsøy
country: Norway
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Pasig City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
state: Ochojec
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Radom
country: Poland
facility: Research Site
city: Rzeszow
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Szczecin
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: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Zielona Gora
country: Poland
facility: Research Site
city: Dolny Kubin
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Lubochna
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Sahy
country: Slovakia
facility: Research Site
city: Trencin
country: Slovakia
facility: Research Site
city: Velky Meder
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Borås
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Mölndal
country: Sweden
facility: Research Site
city: Partille
country: Sweden
facility: Research Site
city: Skene
country: Sweden
facility: Research Site
city: Stenungsund
country: Sweden
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
city: Vänersborg
country: Sweden
facility: Research Site
city: Åmål
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: