Type 2 DiabetesPhase 2NCT00280865
GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
A Phase 2 study testing Tesaglitazar, Pioglitazone and Dietary and Lifestyle Modification Counseling in people with Type 2 Diabetes, run by AstraZeneca at 110 sites in 4 countries.
Trial summary
This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) 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 30 to 50 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tesaglitazar, Pioglitazone and Dietary and Lifestyle Modification Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 110 sitesin 4 countries
- Study dates
- Apr 2002to Jun 2003
- Phase
- Phase 2
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provision of a written informed consent
- Men or women who are 30 to 80 years of age
- Female patients: postmenopausal or surgically sterile
- Diagnosed with type 2 diabetes with C-peptide levels > 0.8 ng/mL
- 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), or to other PPAR g or PPAR a and g agonists.
- History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
- Creatinine levels above 1.2 mg/dL
- Received any investigational product in other clinical studies within 30 days
- 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
110 sites in 4 countries.
110 sites in 4 countries
United States90 sites
Research Site
Albany, New York
Research Site
Alhambra, California
Research Site
Altoona, Pennsylvania
Research Site
Anaheim, California
Research Site
Ann Arbor, Michigan
Research Site
Arlington, Texas
Research Site
Atlanta, Georgia
Research Site
Augusta, Georgia
Research Site
Baltimore, Maryland
Research Site
Bangor, Maine
Research Site
Birmingham, Alabama
Research Site
Blue Ridge, Georgia
Research Site
Brandon, Florida
Research Site
Brooklyn, New York
Research Site
Buffalo, New York
Research Site
Cadillac, Michigan
Research Site
Canfield, Ohio
Research Site
Charlotte, North Carolina
Research Site
Cheswick, Pennsylvania
Research Site
Cincinnati, Ohio
Research Site
Columbia, South Carolina
Research Site
Columbus, Ohio
Research Site
Coral Gables, Florida
Research Site
Corpus Christi, Texas
Research Site
Dallas, Texas
Research Site
DeLand, Florida
Research Site
Dinuba, California
Research Site
Dunwoody, Georgia
Research Site
Edmonds, Washington
Research Site
Escondido, California
Research Site
Eugene, Oregon
Research Site
Evansville, Indiana
Research Site
Falls Church, Virginia
Research Site
Fresno, California
Research Site
Gainesville, Florida
Research Site
Greenbrae, California
Research Site
Gurnee, Illinois
Research Site
Henderson, Nevada
Research Site
Hickory, North Carolina
Research Site
Hollywood, Florida
Research Site
Huntington, West Virginia
Research Site
Huntsville, Alabama
Research Site
Indianapolis, Indiana
Research Site
Jackson, Mississippi
Research Site
Kettering, Ohio
Research Site
Lakewood, Ohio
Research Site
Las Vegas, Nevada
Research Site
Lawrenceville, New Jersey
Research Site
Long Beach, California
Research Site
Louisville, Kentucky
Research Site
Lubbock, Texas
Research Site
Mesa, Arizona
Research Site
Miami, Florida
Research Site
Mission Viejo, California
Research Site
Montgomery, Alabama
Research Site
New Hyde Park, New York
Research Site
New Orleans, Louisiana
Research Site
New York, New York
Research Site
Newark, New Jersey
Research Site
Ninety Six, South Carolina
Research Site
Norfolk, Virginia
Research Site
North Richland Hills, Texas
Research Site
Oklahoma City, Oklahoma
Research Site
Omaha, Nebraska
Research Site
Orange, California
Research Site
Pahrump, Nevada
Research Site
Penndel, Pennsylvania
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Renton, Washington
Research Site
Richmond, Virginia
Research Site
Sacramento, California
Research Site
Salisbury, Massachusetts
Research Site
Salt Lake City, Utah
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Sioux Falls, South Dakota
Research Site
Springfield, Illinois
Research Site
St Louis, Missouri
Research Site
Stamford, Connecticut
Research Site
Summerville, South Carolina
Research Site
Tucson, Arizona
Research Site
Walnut Creek, California
Research Site
Warminster, Pennsylvania
Research Site
Warwick, Rhode Island
Research Site
Washington D.C., District of Columbia
Research Site
Waterbury, Connecticut
Research Site
Wichita, Kansas
Research Site
Winston-Salem, North Carolina
Research Site
Worcester, Massachusetts
Canada10 sites
Research Site
Burlington, Ontario
Research Site
Courtice, Ontario
Research Site
Edmonton, Alberta
Research Site
Granby, Quebec
Research Site
Laval, Quebec
Research Site
Longueuil
Research Site
Montreal
Research Site
Sherbrooke
Research Site
Windsor
Research Site
Winnipeg
France7 sites
Research Site
Andard
Research Site
Angers
Research Site
Avrillé
Research Site
Chalonnes-sur-Loire
Research Site
Montrevault
Research Site
Segré
Research Site
Tiercé
Mexico3 sites
Research Site
Colonia del Valle
Research Site
Colonia Seccion XVI
Research Site
Delegacion Cuauhtemoc
About this study
Official title: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period
- Conditions
- Type 2 Diabetes
- Being tested
- Tesaglitazar, Pioglitazone, Dietary and Lifestyle Modification Counseling
- Keywords
- Tesaglitazar, 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.
TesaglitazarDrug
PioglitazoneDrug
Dietary and Lifestyle Modification CounselingBehavioural
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 fasting plasma glucose (FPG)
Secondary outcomes (9)
Changes in the following variables from baseline to the end of the randomized treatment period:
The change in plasma glucose and insulin during an oral glucose tolerance test
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
Change in insulin levels and hemoglobin A1c (HbA1c) levels
Responder analyses for FPG, TG, and HDL C according to pre-specified values
Pharmacokinetics of tesaglitazar
To assess the burden of type 2 diabetes mellitus in patients through the administration of the SF-36 health survey and the Well-Being Questionnaire (W BQ12) and comparing the study population data to published national and international normative data
To evaluate diabetes-specific instruments, Audit of Diabetes Dependent Quality of Life (ADDQoL) and The Diabetes Treatment Satisfaction Questionnaire (DTSQ) (s and c) in the study population and estimate the effect size of the instruments in patients r
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startApr 2002
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 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
- NCT00280865
- Sponsor's protocol ID
- SH-SBD-0001
- Other IDs
- GLAD
- Status last verified
- Jul 2006
- First submitted
- 20 Jan 2006
- Last updated
- 31 Jul 2006
- Results posted
- No
Publications
Goldstein BJ, Rosenstock J, Anzalone D, Tou C, Ohman KP. Effect of tesaglitazar, a dual PPAR alpha/gamma agonist, on glucose and lipid abnormalities in patients with type 2 diabetes: a 12-week dose-ranging trial. Curr Med Res Opin. 2006 Dec;22(12):2575-90. doi: 10.1185/030079906x154169.
PubMed 17166340
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00280865
- Acronym / sponsor ID
- SH-SBD-0001
- Conditions
- Type 2 Diabetes
- Keywords
- Tesaglitazar, type 2 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Jun 2003
- First posted
- 24 Jan 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 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of a written informed consent
- Men or women who are 30 to 80 years of age
- Female patients: postmenopausal or surgically sterile
- Diagnosed with type 2 diabetes with C-peptide levels > 0.8 ng/mL
- Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
Key exclusion criteria (8 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), or to other PPAR g or PPAR a and g agonists.
- 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 | – |
| Pioglitazone | Drug | – |
| Dietary and Lifestyle Modification Counseling | Behavioural | – |
Primary outcome
Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)
9 secondary outcomes
Changes in the following variables from baseline to the end of the randomized treatment period:
The change in plasma glucose and insulin during an oral glucose tolerance test
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
Change in insulin levels and hemoglobin A1c (HbA1c) levels
Responder analyses for FPG, TG, and HDL C according to pre-specified values
Pharmacokinetics of tesaglitazar
To assess the burden of type 2 diabetes mellitus in patients through the administration of the SF-36 health survey and the Well-Being Questionnaire (W BQ12) and comparing the study population data to published national and international normative data
To evaluate diabetes-specific instruments, Audit of Diabetes Dependent Quality of Life (ADDQoL) and The Diabetes Treatment Satisfaction Questionnaire (DTSQ) (s and c) in the study population and estimate the effect size of the instruments in patients r
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2006.
- Derived from this study: PubMed 17166340Goldstein BJ, Rosenstock J, Anzalone D, Tou C, Ohman KP. Effect of tesaglitazar, a dual PPAR alpha/gamma agonist, on glucose and lipid abnormalities in patients with type 2 diabetes: a 12-week dose-ranging trial. Curr Med Res Opin. 2006 Dec;22(12):2575-90. doi: 10.1185/030079906x154169.
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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
110 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesaglitazar, Pioglitazone and Dietary and Lifestyle Modification Counseling in people with Type 2 Diabetes, run by AstraZeneca at 110 sites in 4 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 8 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: finished, as of the sponsor's last update on 31 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, Canada, France, Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 fasting plasma glucose (FPG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00280865, which also lists 1 linked publication.
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 31 Jul 2006.