Type 2 Diabetes MellitusPhase 3NCT00242372
GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin
A Phase 3 study testing Tesaglitazar 0.5 and Insulin at least 30 units/day in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 71 sites in United States.
Trial summary
This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Tesaglitazar 0.5 and Insulin at least 30 units/day
- How many people
- 370 participants
- Where
- 71 sitesUnited States
- Study dates
- Aug 2004to Mar 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 for less than 20 years and receiving at least 30 U insulin per day
Who cannot join
- Type 1 diabetes
- New York Heart Association heart failure Class III or IV
- Treatment with any thiazolidinedione class of antidiabetic agents
- 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
71 sites in 1 country.
71 sites in 1 country
United States71 sites
Research Site
Albuquerque, New Mexico
Research Site
Altoona, Pennsylvania
Research Site
Augusta, Georgia
Research Site
Baltimore, Maryland
Research Site
Bellevue, Washington
Research Site
Bethesda, Maryland
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
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Columbia, South Carolina
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Corpus Christie, 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
Maywood, Illinois
Research Site
Medford, Oregon
Research Site
Miami, Florida
Research Site
New Hyde Park, New York
Research Site
New Orleans, Louisiana
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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
Research Site
Phoenix, Arizona
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Portland, Oregon
Research Site
Renton, Washington
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Richmond, Virginia
Research Site
Richmond Heights, Missouri
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Riverside, California
Research Site
Roseland, New Jersey
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
Tuscson, 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: A 24-Week Randomised, Double-Blind, 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 Insulin
This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Tesaglitazar 0.5, Insulin at least 30 units/day
- Keywords
- Insulin dependent Type 2 diabetes
- 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 0.5Drug
Insulin at least 30 units/dayDrug
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 (15)
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 from baseline to the end of the randomized treatment period
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model from baseline to the end of the randomized treatment period
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
To validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI-Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) in patients with type 2 diabetes and to explore the effects of tesaglitazar (0.5 mg) on pati
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startAug 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 Diabetes MellitusStudies 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
- 370 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Galida Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242372
- Sponsor's protocol ID
- D6160C00033
- Status last verified
- Apr 2009
- First submitted
- 19 Oct 2005
- Last updated
- 22 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week Randomised, Double-Blind, 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 Insulin
- ClinicalTrials.gov ID
- NCT00242372
- Acronym / sponsor ID
- D6160C00033
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Insulin dependent Type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The development program has been terminated
- Enrolment
- 370 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 20 Oct 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 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.
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
- Diagnosed with type 2 diabetes for less than 20 years and receiving at least 30 U insulin per day
Key exclusion criteria (9 listed)
- Type 1 diabetes
- New York Heart Association heart failure Class III or IV
- Treatment with any thiazolidinedione class of antidiabetic agents
- 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 0.5 | Drug | – |
| Insulin at least 30 units/day | Drug | – |
Primary outcome
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
15 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 from baseline to the end of the randomized treatment period
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model from baseline to the end of the randomized treatment period
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
To validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI-Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) in patients with type 2 diabetes and to explore the effects of tesaglitazar (0.5 mg) on pati
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 22 Apr 2009.
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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 Sciences Director, MD study director
AstraZeneca
71 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 0.5 and Insulin at least 30 units/day in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 71 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 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 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?
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 22 Apr 2009.