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GALLANT 4 Tesaglitazar vs. Glibenclamide

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Tesaglitazar (Drug); Glibenclamide (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Galida Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary outcome:

Changes in the following variables from baseline to the end of the randomized treatment period:

The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide

Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model

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

C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio

FPG, homeostasis assessment model, insulin, proinsulin, C-peptide

Tumor necrosis factor-alpha, intracellular adhesion molecule-1

Fibrinogen

Urinary albumin excretion

Waist/hip ratio

Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values

Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C

Pharmacokinetics of tesaglitazar

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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, Belgium

Research Site, Shatin, N.T., Hong Kong

Research Site, Balatonfüred, Hungary

Research Site, Budapest, Hungary

Research Site, Kaposvár, Hungary

Research Site, Kecskemét, Hungary

Research Site, Székesfehérvár, Hungary

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, Italy

Research Site, Kuala Lampur, Malaysia

Research Site, Veracruz, Mexico

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, Norway

Research Site, Ås, Norway

Research Site, Manila, Philippines

Research Site, Pasig City, Philippines

Research Site, Kraków, Poland

Research Site, Lublin, Poland

Research Site, P³ock, Poland

Research Site, Toruñ, Poland

Research Site, Tychy, Poland

Research Site, Warszawa, Poland

Research Site, £ód?, Poland

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, Slovakia

Research Site, Cape Town, South Africa

Research Site, Durban, South Africa

Research Site, Houghton Gauteng, South Africa

Research Site, Changhua, Taiwan

Research Site, Taichung, Taiwan

Research Site, Taipei, Taiwan

Research Site, Bangkok, Thailand

Research Site, México, D.f., Mexico

Research Site, Guadalajara, Jalisco, Mexico

Research Site, Zapopan, Jalisco, Mexico

Research Site, Kubang Kerian, Kota Bharu, Malaysia

Additional Information

Starting date: September 2004
Last updated: March 14, 2008

Page last updated: August 23, 2015

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