GALLANT 22 Tesaglitazar vs. Placebo

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00252837
• Other study ID #: D6160C00055
• Secondary ID: EudraCT No 2004-
• Status: Terminated
• Phase: Phase 3
• First received: November 10, 2005
• Last updated: March 14, 2008
• Start date: April 2005
• Est. completion date: December 2006

Study information

• Verified date: March 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 475
• Est. completion date: December 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

• 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

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

Behavioral:
• Dietary and Lifestyle counseling

Locations

Country	Name	City	State
Australia	Research Site	Adelaide
Australia	Research Site	Cairns
Australia	Research Site	Gosford
Australia	Research Site	Keswick
Australia	Research Site	Kippa Ring
Australia	Research Site	Melbourne
Australia	Research Site	Miranda
Australia	Research Site	Nowra
Australia	Research Site	Wollongong
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Hodonin
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha 5
Czech Republic	Research Site	Pribram
Czech Republic	Research Site	Semily
Czech Republic	Research Site	Tabor
Czech Republic	Research Site	Usti nad Labem
Estonia	Research Site	Paide
Estonia	Research Site	Pärnu
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Estonia	Research Site	Viljandi
Former Serbia and Montenegro	Research Site	Belgrade
France	Research Site	Angers
France	Research Site	Briollay
France	Research Site	Poitiers
France	Research Site	Saint Benoit
France	Research Site	Saint Ouen
France	Research Site	Toulouse
France	Research Site	Trelaze
Greece	Research Site	Athens
Greece	Research Site	Piraeus
Hungary	Research Site	Balatonfüred
Hungary	Research Site	Budapest
Hungary	Research Site	Kaposvár
Hungary	Research Site	Kecskemét
Hungary	Research Site	Székesfehérvár
Latvia	Research Site	Daugavpils
Latvia	Research Site	Jekabpils
Latvia	Research Site	Madona
Latvia	Research Site	Riga
Latvia	Research Site	SIgulda
Latvia	Research Site	Talsi
Latvia	Research Site	Valmiera
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Klaipeda
Lithuania	Research Site	Panevezys
Lithuania	Research Site	Vilnius
Norway	Research Site	Aurskog
Norway	Research Site	Bergen
Norway	Research Site	Enebakk
Norway	Research Site	Fredrikstad
Norway	Research Site	Haugesund
Norway	Research Site	Hønefoss
Norway	Research Site	Inderøy
Norway	Research Site	Larvik
Norway	Research Site	Lierskogen
Norway	Research Site	Oslo
Norway	Research Site	Rolvsøy
Philippines	Research Site	Cebu City
Philippines	Research Site	Pasig City
Philippines	Research Site	Quezon City
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Katowice	Ochojec
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Olsztyn
Poland	Research Site	Poznan
Poland	Research Site	Radom
Poland	Research Site	Rzeszow
Poland	Research Site	Sopot
Poland	Research Site	Szczecin
Poland	Research Site	Toruñ
Poland	Research Site	Tychy
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Zabrze
Poland	Research Site	Zielona Gora
Slovakia	Research Site	Dolny Kubin
Slovakia	Research Site	Levice
Slovakia	Research Site	Lubochna
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Nove Zamky
Slovakia	Research Site	Povazska Bystrica
Slovakia	Research Site	Sahy
Slovakia	Research Site	Trencin
Slovakia	Research Site	Velky Meder
Slovakia	Research Site	Zilina
Sweden	Research Site	Åmål
Sweden	Research Site	Borås
Sweden	Research Site	Göteborg
Sweden	Research Site	Mölndal
Sweden	Research Site	Partille
Sweden	Research Site	Skene
Sweden	Research Site	Stenungsund
Sweden	Research Site	Uddevalla
Sweden	Research Site	Vänersborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Czech Republic,  Estonia,  Former Serbia and Montenegro,  France,  Greece,  Hungary,  Latvia,  Lithuania,  Norway,  Philippines,  Poland,  Slovakia,  Sweden, 

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	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	Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
Secondary	Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Secondary	Fibrinogen
Secondary	Proportion of patients with microalbuminuria
Secondary	Waist/hip ratio
Secondary	Responder analyses for HbA1c, FPG, TG, HDL C, 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
Secondary	Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Secondary	Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.