Type 2 DiabetesPhase 3NCT00251940
GALLANT 7 Tesaglitazar Add-on to Sulphonylurea
A Phase 3 study testing Tesaglitazar 0.5 or 1 mg and Glibenclamide 2.5, 5, 10 or 15 mg in people with Type 2 Diabetes, run by AstraZeneca at 84 sites in 10 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tesaglitazar 0.5 or 1 mg and Glibenclamide 2.5, 5, 10 or 15 mg
- How many people
- 555 participants
- Where
- 84 sitesin 10 countries
- Study dates
- Jul 2004to Mar 2006
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
84 sites in 10 countries.
84 sites in 10 countries
United Kingdom21 sites
Research Site
Aberdeen
Research Site
Barnsley
Research Site
Bath
Research Site
Belfast
Research Site
Birmingham
Research Site
Cardiff
Research Site
Coventry
Research Site
Dublin, Ireland
Research Site
Dundee
Research Site
East Sussex
Research Site
Edinburgh
Research Site
Glasgow
Research Site
Leeds
Research Site
Liverpool
Research Site
London
Research Site
Manchester
Research Site
Shrewsbury
Research Site
Surrey
Research Site
West Midlands
Research Site
Wiltshire
Research Site
Wrexham
Norway16 sites
Research Site
Bergen
Research Site
Elverum
Research Site
Enebakk
Research Site
Fredrikstad
Research Site
Gamle Fredrikstad
Research Site
Hamar
Research Site
Haugesund
Research Site
Hurdal
Research Site
Inderøy
Research Site
Lena
Research Site
Levanger
Research Site
Oslo
Research Site
Rud
Research Site
Sedsmokorset
Research Site
Soerumsand
Research Site
Stavanger
France13 sites
Research Site
Angers
Research Site
Hyères
Research Site
La Garde
Research Site
La Seyne-sur-Mer
Research Site
Laval
Research Site
Le Brusc
Research Site
Le Lavandou
Research Site
Montrevault
Research Site
Paris
Research Site
Saint-Cyr
Research Site
Six-Fours-les-Plages
Research Site
Tiercé
Research Site
Toulon
Australia8 sites
Research Site
Adelaide
Research Site
Brisbane
Research Site
Cairns
Research Site
Geelong
Research Site
Melbourne
Research Site
Perth
Research Site
Sydney
Research Site
Tasmania
Israel8 sites
Research Site
Ashkelon
Research Site
Haifa
Research Site
Holon
Research Site
Jerusalem
Research Site
Rishon LeZiyyon
Research Site
Safed
Research Site
Tel Aviv
Research Site
Tel Litwinsky
Spain7 sites
Research Site
Alzira (Valencia)
Research Site
Barcelona
Research Site
Guissona (Lleida)
Research Site
Madrid
Research Site
San Sebastian de Los Reyes ( Madrid)
Research Site
San Vicente de Raspeig (Alicante)
Research Site
Valencia
South Africa4 sites
Research Site
Cape Town
Research Site
Chatsworth
Research Site
Gauteng
Research Site
Pretoria
Philippines3 sites
Research Site
Manila
Research Site
Marikina City
Research Site
Pasig
About this study
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
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
- Conditions
- Type 2 Diabetes
- Being tested
- Tesaglitazar 0.5 or 1 mg, Glibenclamide 2.5, 5, 10 or 15 mg
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tesaglitazar 0.5 or 1 mgDrug
Glibenclamide 2.5, 5, 10 or 15 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary outcomes (14)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startJul 2004
- Study completionMar 2006
Why it stopped: The development program has been terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 555 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Galida Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251940
- Sponsor's protocol ID
- D6160C00032
- Other IDs
- EudraCT No 2004-001144-71
- Status last verified
- Mar 2008
- First submitted
- 9 Nov 2005
- Last updated
- 17 Mar 2008
- Results posted
- No