Diabetes Mellitus, Type 2Phase 3NCT00229710
GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes
A Phase 3 study testing Tesaglitazar in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 69 sites in United States.
Trial summary
This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Tesaglitazar
- Type of treatment
- Pill or oral medicine
- How many people
- 270 participants
- Where
- 69 sitesUnited States
- Study dates
- Feb 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 the randomized treatment period in GALLANT 9
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, or neutropenia (low white blood cells)
- Creatinine levels of above twice the normal range
Show all 9Show fewer
- Creatine kinase of 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
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Research Site
Albuquerque, New Mexico
Research Site
Altoona, Pennsylvania
Research Site
Augusta, Georgia
Research Site
Baltimore, Maryland
Research Site
Bellevue, Washington
Research Site
Birmingham, Alabama
Research Site
Boise, Idaho
Research Site
Brooklyn, New York
Research Site
Cadillac, Michigan
Research Site
Charlotte, North Carolina
Research Site
Cheswick, Pennsylvania
Research Site
Chicago, Illinois
Research Site
Chicago Heights, Illinois
Research Site
Cincinnati, Ohio
Research Site
Columbia, South Carolina
Research Site
Corpus Christi, Texas
Research Site
Dallas, Texas
Research Site
Dover, New Hampshire
Research Site
Dunwoody, Georgia
Research Site
Erie, Pennsylvania
Research Site
Fort Worth, Texas
Research Site
Fresno, California
Research Site
Gainesville, Florida
Research Site
Greenbrae, California
Research Site
Greer, South Carolina
Research Site
Gurnee, Illinois
Research Site
Hollywood, Florida
Research Site
Houston, Texas
Research Site
Indianapolis, Indiana
Research Site
Jacksonville, Florida
Research Site
Kettering, Ohio
Research Site
La Jolla, California
Research Site
Madison, Wisconsin
Research Site
Medford, Oregon
Research Site
Miami, Florida
Research Site
New Hyde Park, New York
Research Site
New Orleans, Louisiana
Research Site
North Las Vegas, Nevada
Research Site
Northridge, California
Research Site
Oklahoma City, Oklahoma
Research Site
Omaha, Nebraska
Research Site
Orlando, Florida
Research Site
Pahrump, Nevada
Research Site
Palm Harbor, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Portland, Oregon
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Renton, Washington
Research Site
Richmond, Virginia
Research Site
Richmond Heights, Missouri
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Riverside, California
Research Site
Roseland, Texas
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Santa Monica, California
Research Site
Spokane, Washington
Research Site
Spring Valley, California
Research Site
Springfield, Illinois
Research Site
St Louis, Missouri
Research Site
Tacoma, Washington
Research Site
Toledo, Ohio
Research Site
Tucson, Arizona
Research Site
Walnut Creek, California
Research Site
Washington D.C., District of Columbia
Research Site
Waterbury, Connecticut
Research Site
West Hills, California
Research Site
West Palm Beach, Florida
Research Site
Wichita, Kansas
Research Site
Wilmington, North Carolina
About this study
Official title: An Open-Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 0.5mg When Added to Insulin Therapy in Patients With Type 2 Diabetes Mellitus (GALLEX 9)
This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Tesaglitazar
- Keywords
- Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus
- 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
Also called Galida
0.5 in combination with insulin (with or without other oral antidiabetic drugs)
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 (5)
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
C-reactive protein (CRP)
Central obesity (waist circumference, hip circumference, 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 posted30 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionDec 2006
- 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 Diabetes Mellitus, Type 2Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 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
- NCT00229710
- Sponsor's protocol ID
- D6160C00049
- Status last verified
- Nov 2010
- First submitted
- 28 Sep 2005
- Last updated
- 19 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 0.5mg When Added to Insulin Therapy in Patients With Type 2 Diabetes Mellitus (GALLEX 9)
- ClinicalTrials.gov ID
- NCT00229710
- Acronym / sponsor ID
- D6160C00049
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The development program has been terminated
- Enrolment
- 270 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Sep 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 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 the randomized treatment period in GALLANT 9
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, or 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 |
|---|---|---|
| TesaglitazarAlso: Galida0.5 in combination with insulin (with or without other oral antidiabetic drugs) | Drug | – |
Primary outcome
Adverse events
Laboratory variables
Physical examination
Cardiac evaluation
Hypoglycemic events
Electrocardiogram
Vital signs (blood pressure and pulse)
Body weight
5 secondary outcomes
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
C-reactive protein (CRP)
Central obesity (waist circumference, hip circumference, 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 19 Nov 2010.
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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
69 sites in 1 country: 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 Diabetes Mellitus, Type 2, run by AstraZeneca at 69 sites in United States.
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 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. 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. The study lists 8 primary outcomes in all. 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 19 Nov 2010.