Type 2 DiabetesPhase 3NCT00255541
GALLANT 4 Tesaglitazar vs. Glibenclamide
A Phase 3 study testing Tesaglitazar and Glibenclamide in people with Type 2 Diabetes, run by AstraZeneca at 66 sites in 13 countries.
Trial 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. 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 and Glibenclamide
- How many people
- 580 participants
- Where
- 66 sitesin 13 countries
- Study dates
- Sep 2004to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 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
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
Show all 9Show fewer
- 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
66 sites in 13 countries.
66 sites in 13 countries
Italy14 sites
Research Site
Arenzano
Research Site
Chiavari (GE)
Research Site
Chieri
Research Site
Gubbio (PG)
Research Site
Milan
Research Site
Naples
Research Site
Padova
Research Site
Perugia
Research Site
Piacenza
Research Site
Reggio Calabria
Research Site
Reggio Emilia
Research Site
Rho
Research Site
Roma
Research Site
Udine
Slovakia9 sites
Research Site
Bratislava
Research Site
Ilava
Research Site
Košice
Research Site
Kysucké Nové Mesto
Research Site
Ľubochňa
Research Site
Lučenec
Research Site
Nitra
Research Site
Prešov
Research Site
Trnava
Norway8 sites
Research Site
Ås
Research Site
Bergen
Research Site
Kongsvinger
Research Site
Lysaker
Research Site
Oslo
Research Site
Skedsmokorset
Research Site
Sørumstand
Research Site
Trondheim
Belgium7 sites
Research Site
Antwerp
Research Site
Braine-l'Alleud
Research Site
Hasselt
Research Site
Liège
Research Site
Merksem
Research Site
Sint-Gillis-Waas
Research Site
Steenokkerzeel
Poland7 sites
Research Site
£ód?
Research Site
Krakow
Research Site
Lublin
Research Site
P³ock
Research Site
Toruñ
Research Site
Tychy
Research Site
Warsaw
Hungary5 sites
Research Site
Balatonfüred
Research Site
Budapest
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Székesfehérvár
Mexico4 sites
Research Site
Guadalajara, Jalisco
Research Site
México, D.F.
Research Site
Veracruz
Research Site
Zapopan, Jalisco
South Africa3 sites
Research Site
Cape Town
Research Site
Durban
Research Site
Houghton Gauteng
Malaysia2 sites
Research Site
Kuala Lampur
Research Site
Kubang Kerian, Kota Bharu
About this study
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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Tesaglitazar, Glibenclamide
- 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.
TesaglitazarDrug
GlibenclamideDrug
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 posted21 Nov 2005 (estimated)
- Study startSep 2004
- Study completionDec 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
- 580 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
- NCT00255541
- Sponsor's protocol ID
- D6160C00028
- Status last verified
- Mar 2008
- First submitted
- 17 Nov 2005
- Last updated
- 17 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00255541
- Acronym / sponsor ID
- D6160C00028
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The development program has been terminated
- Enrolment
- 580 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tesaglitazar | Drug | – |
| Glibenclamide | Drug | – |
Primary outcome
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
14 secondary outcomes
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
Results and safety
The study was stopped early (reason given: The development program has been terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Galida Medical Science Director, MD study director
AstraZeneca
66 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tesaglitazar and Glibenclamide in people with Type 2 Diabetes, run by AstraZeneca at 66 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Italy, Slovakia, Norway, Belgium, Poland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The development program has been terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2008.