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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
Est. primary completion date
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


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.
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