Type 2 DiabetesPhase 3NCT00300105
GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes
A Phase 3 study testing Tesaglitazar in people with Type 2 Diabetes, run by AstraZeneca at 42 sites in 10 countries.
Trial summary
This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 weeks. 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
- How many people
- 400 participants
- Where
- 42 sitesin 10 countries
- Study dates
- Oct 2005to 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
- Completed the last two visits of randomized treatment period in GALLANT 4
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
- Previous enrollment in this long-term extension study
- 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
42 sites in 10 countries.
42 sites in 10 countries
Slovakia10 sites
Research Site
Banská Bystrica
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
Poland7 sites
Research Site
£ód?
Research Site
Krakow
Research Site
Lublin
Research Site
Płock
Research Site
Torun
Research Site
Tychy
Research Site
Warsaw
Italy6 sites
Research Site
Gubbio
Research Site
Milan
Research Site
Perugia
Research Site
Piacenza
Research Site
Reggio Emilia
Research Site
Udine
Hungary5 sites
Research Site
Balatonfüred
Research Site
Budapest
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Székesfehérvár
Belgium4 sites
Research Site
Hasselt
Research Site
Liège
Research Site
Sint-Gillis-Waas
Research Site
Steenokkerzeel
Philippines3 sites
Research Site
Makati City
Research Site
Manila
Research Site
Pasig
South Africa3 sites
Research Site
Cape Town
Research Site
Durban
Research Site
Johannesburg, Gauteng
Malaysia2 sites
Research Site
Kuala Lumpur
Research Site
Kubang Kerian, Kelantan
About this study
Official title: A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar Therapy in Patients With Type 2 Diabetes
This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- Tesaglitazar
- Keywords
- Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 4
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Secondary outcomes (11)
Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
Time to treatment failure
Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
Markers of insulin resistance by assessment of insulin homeostasis assessment model
Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
Changes in lipid variables (triglyceride, total cholesterol, high-density lipoprotein cholesterol [HDL-C], non-HDL-C, low-density lipoprotein cholesterol, low-density lipoprotein cholesterol/HDL-C, apolipoprotein [Apo] B, ApoA-1, ApoB/ApoA-1
Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
Urinary albumin excretion
Central obesity (waist circumference, hip circumference and waist/hip ratio)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startOct 2005
- 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
- 400 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
- NCT00300105
- Sponsor's protocol ID
- D6160C00047
- Other IDs
- EudraCT No 2004-005243-97
- Status last verified
- Mar 2008
- First submitted
- 7 Mar 2006
- 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 Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar Therapy in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00300105
- Acronym / sponsor ID
- D6160C00047
- Conditions
- Type 2 Diabetes
- Keywords
- Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The development program has been terminated
- Enrolment
- 400 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 8 Mar 2006 (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 parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 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 (4 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
- Completed the last two visits of randomized treatment period in GALLANT 4
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 | – |
Primary outcome
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
11 secondary outcomes
Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
Time to treatment failure
Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
Markers of insulin resistance by assessment of insulin homeostasis assessment model
Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
Changes in lipid variables (triglyceride, total cholesterol, high-density lipoprotein cholesterol [HDL-C], non-HDL-C, low-density lipoprotein cholesterol, low-density lipoprotein cholesterol/HDL-C, apolipoprotein [Apo] B, ApoA-1, ApoB/ApoA-1
Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
Urinary albumin excretion
Central obesity (waist circumference, hip circumference and waist/hip ratio)
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
42 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tesaglitazar in people with Type 2 Diabetes, run by AstraZeneca at 42 sites in 10 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 4 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 42 sites in Slovakia, Poland, Italy, Hungary, Belgium and 5 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?
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight. 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.