GALLANT 4 Tesaglitazar vs. Glibenclamide

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00255541
• Other study ID #: D6160C00028
• Status: Terminated
• Phase: Phase 3
• First received: November 17, 2005
• Last updated: March 14, 2008
• Start date: September 2004
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 580
• 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

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

• Glibenclamide

Locations

Country	Name	City	State
Belgium	Research Site	Antwerpen
Belgium	Research Site	Braine-L'alleud
Belgium	Research Site	Hasselt
Belgium	Research Site	Liege
Belgium	Research Site	Merksem
Belgium	Research Site	Sint-Gillis-Waas
Belgium	Research Site	Steenokkerzeel
Hong Kong	Research Site	Shatin, N.T.
Hungary	Research Site	Balatonfüred
Hungary	Research Site	Budapest
Hungary	Research Site	Kaposvár
Hungary	Research Site	Kecskemét
Hungary	Research Site	Székesfehérvár
Italy	Research Site	Arenzano
Italy	Research Site	Chiavari (GE)
Italy	Research Site	Chieri
Italy	Research Site	Gubbio (PG)
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Perugia
Italy	Research Site	Piacenza
Italy	Research Site	Reggio Calabria
Italy	Research Site	Reggio Emilia
Italy	Research Site	Rho
Italy	Research Site	Roma
Italy	Research Site	Udine
Malaysia	Research Site	Kuala Lampur
Malaysia	Research Site	Kubang Kerian	Kota Bharu
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	México	D.f.
Mexico	Research Site	Veracruz
Mexico	Research Site	Zapopan	Jalisco
Norway	Research Site	Ås
Norway	Research Site	Bergen
Norway	Research Site	Kongsvinger
Norway	Research Site	Lysaker
Norway	Research Site	Oslo
Norway	Research Site	Skedsmokorset
Norway	Research Site	Sørumstand
Norway	Research Site	Trondheim
Philippines	Research Site	Manila
Philippines	Research Site	Pasig City
Poland	Research Site	£ód?
Poland	Research Site	Kraków
Poland	Research Site	Lublin
Poland	Research Site	P³ock
Poland	Research Site	Toruñ
Poland	Research Site	Tychy
Poland	Research Site	Warszawa
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Ilava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Kysucke Nove Mesto
Slovakia	Research Site	Lubochna
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Nitra
Slovakia	Research Site	Presov
Slovakia	Research Site	Trnava
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Houghton Gauteng
Taiwan	Research Site	Changhua
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Thailand	Research Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Hong Kong,  Hungary,  Italy,  Malaysia,  Mexico,  Norway,  Philippines,  Poland,  Slovakia,  South Africa,  Taiwan,  Thailand, 

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	The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Secondary	Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
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	FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Secondary	Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Secondary	Fibrinogen
Secondary	Urinary albumin excretion
Secondary	Waist/hip ratio
Secondary	Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, 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