Clinical trial NCT00251940: GALLANT 7 Tesaglitazar Add-on to Sulphonylurea
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary outcomes:
measure: Changes in the following variables from baseline to the end of the randomized treatment period:
measure: • The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
measure: • Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
measure: • 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
measure: • C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
measure: • FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
measure: • Tumor necrosis factor-alpha, intracellular adhesion molecule-1
measure: • Fibrinogen
measure: • Urinary albumin excretion
measure: • Waist/hip ratio
measure: • Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
measure: • Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
measure: • Pharmacokinetics of tesaglitazar
measure: • 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
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Research Site
city: Brisbane
country: Australia
facility: Research Site
city: Cairns
country: Australia
facility: Research Site
city: Geelong
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Perth
country: Australia
facility: Research Site
city: Sydney
country: Australia
facility: Research Site
city: Tasmania
country: Australia
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Hyeres
country: France
facility: Research Site
city: La Garde
country: France
facility: Research Site
city: La Seyne Sur Mer
country: France
facility: Research Site
city: Laval
country: France
facility: Research Site
city: Le Brusc
country: France
facility: Research Site
city: Le Lavandou
country: France
facility: Research Site
city: Montrevault
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Saint-Cyr
country: France
facility: Research Site
city: Six Fours Les Plages
country: France
facility: Research Site
city: Tierce
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Holon
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Rishon-Lezion
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Zefat
country: Israel
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Enebakk
country: Norway
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Gamle Fredrikstad
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Haugesund
country: Norway
facility: Research Site
city: Hurdal
country: Norway
facility: Research Site
city: Inderøy
country: Norway
facility: Research Site
city: Lena
country: Norway
facility: Research Site
city: Levanger
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Rud
country: Norway
facility: Research Site
city: Sedsmokorset
country: Norway
facility: Research Site
city: Soerumsand
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Marikina City
country: Philippines
facility: Research Site
city: Pasig City
country: Philippines
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Chatsworth
country: South Africa
facility: Research Site
city: Gauteng
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Alzira (Valencia)
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Guissona (Lleida)
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: San Sebastian de los Reyes ( Madrid)
country: Spain
facility: Research Site
city: San Vicente de Raspeig (Alicante)
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Dublin
country: United Kingdom
facility: Research Site
state: Ireland
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Barnsley
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: East Sussex
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Shrewsbury
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
city: West Midlands
country: United Kingdom
facility: Research Site
city: Wiltshire
country: United Kingdom
facility: Research Site
city: Wrexham
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: