Diabetes Mellitus, Type 2Phase 3NCT00226330

GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Tesaglitazar and Pioglitazone in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 171 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 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 and Pioglitazone
How many people: 1,100 participants
Where: 171 sitesin 7 countries
Study dates: Mar 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 6

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 by 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

171 sites in 7 countries.

Country

City, postcode or hospital

171 sites in 7 countries

United States110 sites

Research Site
Altoona, Pennsylvania
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Anaheim, California
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Asheville, North Carolina
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Atlanta, Georgia
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Augusta, Georgia
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Baltimore, Maryland
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Berwyn, Illinois
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Birmingham, Alabama
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Brandon, Florida
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Carmichael, California
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Carrollton, Texas
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Chandler, Arizona
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Chicago, Illinois
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Cincinnati, Ohio
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Columbia, Maryland
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Columbia, South Carolina
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Columbiana, Alabama
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Columbus, Georgia
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Cooper City, Florida
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Dallas, Texas
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Delray Beach, Florida
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Des Moines, Iowa
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Dinuba, California
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Dunwoody, Georgia
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Elk Grove, California
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Elk Grove Village, Illinois
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Encinitas, California
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Encino, California
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Erie, Pennsylvania
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Excelsior Springs, Missouri
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Fresno, California
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Gainesville, Florida
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Gig Harbor, Washington
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Greenbrae, California
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Gurnee, Illinois
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Haverhill, Massachusetts
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Hialeah, Florida
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Hollywood, Florida
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Huntington, West Virginia
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Indianapolis, Indiana
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Jacksonville, Florida
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Jonesboro, Arkansas
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Lakewood, Ohio
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Las Vegas, Nevada
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Lexington, Kentucky
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Little Rock, Arkansas
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Loma Linda, California
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Long Beach, California
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Los Angeles, California
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Louisville, Kentucky
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Manlius, New York
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Medford, Oregon
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Melbourne, Florida
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Melrose Park, Illinois
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Memphis, Tennessee
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Mesa, Arizona
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Miami, Florida
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Mission Viejo, California
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Mobile, Alabama
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New Orleans, Louisiana
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New York, New York
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Newark, Delaware
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Norfolk, Virginia
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North Chicago, Illinois
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North Las Vegas, Nevada
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North Richland Hills, Texas
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Northridge, California
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Ocoee, Florida
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Oklahoma City, Oklahoma
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Olean, New York
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Orlando, Florida
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Pahrump, Nevada
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Pasadena, California
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Peoria, Illinois
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Petoskey, Michigan
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Plantation, Florida
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Pleasantville, New Jersey
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Portland, Oregon
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Reading, Pennsylvania
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Redondo Beach, California
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Reno, Nevada
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Richmond Heights, Missouri
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Riverside, California
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Rolla, Missouri
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Sacramento, California
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Salt Lake City, Utah
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San Antonio, Texas
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Santa Ana, California
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Santa Monica, California
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Searcy, Arkansas
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Sierra Vista, Arizona
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Slidell, Louisiana
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Spring Valley, California
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Staten Island, New York
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Sterling, Illinois
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Topeka, Kansas
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Tucson, Arizona
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Tustin, California
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Virginia Beach, Virginia
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Walnut Creek, California
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Warminster, Pennsylvania
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Washington D.C., District of Columbia
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Waterloo, Iowa
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West Chester, Pennsylvania
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West Hills, California
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West Palm Beach, Florida
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Winston-Salem, North Carolina
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Witchita, Kansas

Other trials in United States

Canada22 sites

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Abbotsford British Columbia, British Columbia
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Brampton, Ontario
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Chicoutimi, Quebec
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Chilliwack, British Columbia
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Dartmouth, Nova Scotia
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Edmonton, Alberta
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Etobicoke, Ontario
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Halifax, Nova Scotia
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Kingston, Ontario
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Longueuil, Quebec
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Montreal, Quebec
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Niagara Falls, Ontario
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Oshawa, Ontario
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Scarborough Village, Ontario
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St. Catharines, Ontario
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St. John's, Newfoundland and Labrador
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Toronto, Ontario
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Trois-Rivières, Quebec
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Truro, Nova Scotia
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Vancouver, British Columbia
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Victoria, British Columbia
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Windsor, Nova Scotia

Other trials in Canada

United Kingdom15 sites

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Belfast
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Cardiff
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Co Antrim N Ireland
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Co. Wexford, Ireland
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Dublin
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Edinburgh
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Glasgow
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Kent
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Leeds
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Mid Glamorgan
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Pembrokeshire
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Plymouth
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Reading
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Surrey
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Wiltshire

Other trials in United Kingdom

Argentina6 sites

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Ciudad de Buenos Aires
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Córdoba - Córdoba
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Morón, Buenos Aires
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Quilmes, Buenos Aires
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Rosario
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Salta - Salta

Other trials in Argentina

Brazil6 sites

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Curitiba
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Fortaleza
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Goiânia
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Porto Alegre
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Ribeirão Preto
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São Paulo

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Finland6 sites

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Helsinki
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Jakobstad
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Kauniainen
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Kuopio
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Pori
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Tampere

Other trials in Finland

Mexico6 sites

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Guadalajara, Jalisco.
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México, D.F.
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Nuevo León, Monterrey
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Puebla, Mexico
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Torreón
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Zapopan

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About this study

Official title: A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)

Conditions: Diabetes Mellitus, Type 2
Being tested: Tesaglitazar, Pioglitazone
Keywords: Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.
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 or 1 mg)
PioglitazoneDrug
Also called Actos
(15, 30 or 45 mg)

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 (6)

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)
Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005Dec 2006

First posted27 Sep 2005 (estimated)
Study startMar 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,100 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00226330
Sponsor's protocol ID: D6160C00048
Status last verified: Nov 2010
First submitted: 23 Sep 2005
Last updated: 19 Nov 2010
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

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: A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)
ClinicalTrials.gov ID: NCT00226330
Acronym / sponsor ID: D6160C00048
Conditions: Diabetes Mellitus, Type 2
Keywords: Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The development program has been terminated
Enrolment: 1,100 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: Dec 2006 (actual)
Study completion: Dec 2006 (actual)
First posted: 27 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.

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 the randomized treatment period in GALLANT 6

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: Galida(0.5 or 1 mg)	Drug	–
PioglitazoneAlso: Actos(15, 30 or 45 mg)	Drug	–

Primary outcome

Adverse events
Laboratory variables
Physical examination
Cardiac evaluation
Hypoglycemic events
Electrocardiogram
Vital signs (blood pressure and pulse)
Body weight

6 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)
Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)

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.

Related trials for Diabetes Mellitus, Type 2

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
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Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
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An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
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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.

Galida Medical Science Director, MD study director

AstraZeneca

171 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tesaglitazar and Pioglitazone in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 171 sites in 7 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 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 171 sites in United States, Canada, United Kingdom, Argentina, Brazil and 2 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. 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?

On the ClinicalTrials.gov record for NCT00226330.

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; AzTrials last refreshed its copy on 6 Nov 2026.