DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



GALLANT 7 Tesaglitazar Add-on to Sulphonylurea

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 0.5 or 1 mg (Drug); Glibenclamide 2.5, 5, 10 or 15 mg (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 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0. 5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

Clinical Details

Official title: A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone

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

- 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, Adelaide, Australia

Research Site, Brisbane, Australia

Research Site, Cairns, Australia

Research Site, Geelong, Australia

Research Site, Melbourne, Australia

Research Site, Perth, Australia

Research Site, Sydney, Australia

Research Site, Tasmania, Australia

Research Site, Angers, France

Research Site, Hyeres, France

Research Site, La Garde, France

Research Site, La Seyne Sur Mer, France

Research Site, Laval, France

Research Site, Le Brusc, France

Research Site, Le Lavandou, France

Research Site, Montrevault, France

Research Site, Paris, France

Research Site, Saint-Cyr, France

Research Site, Six Fours Les Plages, France

Research Site, Tierce, France

Research Site, Toulon, France

Research Site, Ashkelon, Israel

Research Site, Haifa, Israel

Research Site, Holon, Israel

Research Site, Jerusalem, Israel

Research Site, Rishon-Lezion, Israel

Research Site, Tel Aviv, Israel

Research Site, Tel Hashomer, Israel

Research Site, Zefat, Israel

Research Site, Seoul, Korea, Republic of

Research Site, Suwon, Korea, Republic of

Research Site, Bergen, Norway

Research Site, Elverum, Norway

Research Site, Enebakk, Norway

Research Site, Fredrikstad, Norway

Research Site, Gamle Fredrikstad, Norway

Research Site, Hamar, Norway

Research Site, Haugesund, Norway

Research Site, Hurdal, Norway

Research Site, Inderøy, Norway

Research Site, Lena, Norway

Research Site, Levanger, Norway

Research Site, Oslo, Norway

Research Site, Rud, Norway

Research Site, Sedsmokorset, Norway

Research Site, Soerumsand, Norway

Research Site, Stavanger, Norway

Research Site, Manila, Philippines

Research Site, Marikina City, Philippines

Research Site, Pasig City, Philippines

Research Site, Cape Town, South Africa

Research Site, Chatsworth, South Africa

Research Site, Gauteng, South Africa

Research Site, Pretoria, South Africa

Research Site, Alzira (Valencia), Spain

Research Site, Barcelona, Spain

Research Site, Guissona (Lleida), Spain

Research Site, Madrid, Spain

Research Site, San Sebastian de los Reyes ( Madrid), Spain

Research Site, San Vicente de Raspeig (Alicante), Spain

Research Site, Valencia, Spain

Research Site, Aberdeen, United Kingdom

Research Site, Barnsley, United Kingdom

Research Site, Bath, United Kingdom

Research Site, Belfast, United Kingdom

Research Site, Birmingham, United Kingdom

Research Site, Cardiff, United Kingdom

Research Site, Coventry, United Kingdom

Research Site, Dundee, United Kingdom

Research Site, East Sussex, United Kingdom

Research Site, Edinburgh, United Kingdom

Research Site, Glasgow, United Kingdom

Research Site, Leeds, United Kingdom

Research Site, Liverpool, United Kingdom

Research Site, London, United Kingdom

Research Site, Manchester, United Kingdom

Research Site, Shrewsbury, United Kingdom

Research Site, Surrey, United Kingdom

Research Site, West Midlands, United Kingdom

Research Site, Wiltshire, United Kingdom

Research Site, Wrexham, United Kingdom

Research Site, Hanoi, Vietnam

Research Site, Ho Chi Minh, Vietnam

Research Site, Dublin, Ireland, United Kingdom

Additional Information

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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017