GALLANT 7 Tesaglitazar Add-on to Sulphonylurea

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00251940
• Other study ID #: D6160C00032
• Secondary ID: EudraCT No 2004-
• Status: Terminated
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: March 14, 2008
• Start date: July 2004
• Est. completion date: March 2006

Study information

• Verified date: March 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• 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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 555
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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 0.5 or 1 mg

• Glibenclamide 2.5, 5, 10 or 15 mg

Locations

Country	Name	City	State
Australia	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
France	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
Israel	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
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon
Norway	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
Philippines	Research Site	Manila
Philippines	Research Site	Marikina City
Philippines	Research Site	Pasig City
South Africa	Research Site	Cape Town
South Africa	Research Site	Chatsworth
South Africa	Research Site	Gauteng
South Africa	Research Site	Pretoria
Spain	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
United Kingdom	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	Dublin	Ireland
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
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  France,  Israel,  Korea, Republic of,  Norway,  Philippines,  South Africa,  Spain,  United Kingdom,  Vietnam, 

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