Type 2 DiabetesPhase 3NCT00261352

GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

A Phase 3 study testing Tesaglitazar, Metformin and Fenofibrate in people with Type 2 Diabetes, run by AstraZeneca at 152 sites in 18 countries.

Terminated

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Tesaglitazar, Metformin and Fenofibrate
How many people: 1,000 participants
Where: 152 sitesin 18 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
Diagnosed with type 2 diabetes
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), 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 the normal range
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

152 sites in 18 countries.

Country

City, postcode or hospital

152 sites in 18 countries

France38 sites

Research Site
Aix-en-Provence
Research Site
Ambriere LES Vallees
Research Site
Béziers
Research Site
Briey
Research Site
Broglie
Research Site
Château-Gontier
Research Site
Cremeaux
Research Site
Falaise
Research Site
Fontaine Saint Martin
Research Site
Freyming-Merlebach
Research Site
Gan
Research Site
Hyères
Research Site
Jarny
Research Site
Jort
Research Site
L'Aigle
Research Site
Lambersart
Research Site
Le Lavandou
Research Site
Lille
Research Site
Lomme
Research Site
Marange-Silvange
Research Site
Marignane
Research Site
Mars-la-Tour
Research Site
Martigues
Research Site
Mayenne
Research Site
Metz
Research Site
Mondelange
Research Site
Montbrison
Research Site
Montpellier
Research Site
Moûtiers
Research Site
Nantes
Research Site
Paris
Research Site
Poitiers
Research Site
Roanne
Research Site
Roquevaire
Research Site
Rugles
Research Site
Saint-Chamond
Research Site
Saint-Jean-de-Luz
Research Site
Tantonville

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Germany22 sites

Research Site
Aschaffenburg
Research Site
Beckum
Research Site
Berlin, State of Berlin
Research Site
Berlin
Research Site
Dresden, Saxony
Research Site
Dresden
Research Site
Düsseldorf, North Rhine-Westphalia
Research Site
Düsseldorf
Research Site
Essen
Research Site
Frankfurt am Main, Hesse
Research Site
Gelnhausen
Research Site
Hanover, Lower Saxony
Research Site
Hanover
Research Site
Heidelberg, Baden-Wurttemberg
Research Site
Heidelberg
Research Site
Heilbronn
Research Site
Künzing
Research Site
München, Bavaria
Research Site
Münster, North Rhine-Westphalia
Research Site
Nuremberg
Research Site
Pirna
Research Site
Stuttgart, Baden-Wurttemberg

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Canada19 sites

Research Site
Bay Roberts, Newfoundland and Labrador
Research Site
Bolton, Ontario
Research Site
Brampton, Ontario
Research Site
Calgary, Alberta
Research Site
Etobicoke, Ontario
Research Site
Hastings, Ontario
Research Site
Kingston, Ontario
Research Site
Kitchener, Ontario
Research Site
London, Ontario
Research Site
Mississauga, Ontario
Research Site
Montreal, Quebec
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
Napanee, Ontario
Research Site
Newboro, Ontario
Research Site
Ottawa, Ontario
Research Site
Pointe-Claire, Quebec
Research Site
Sherbrooke, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
Surrey, British Columbia

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Finland12 sites

Research Site
Helsinki
Research Site
Kuopio
Research Site
Lahti
Research Site
Mikkeli
Research Site
Oulu
Research Site
Porvoo
Research Site
Savonlinna
Research Site
Seinäjoki
Research Site
Suonenjoki
Research Site
Tampere
Research Site
Turku
Research Site
Vaasa

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Norway9 sites

Research Site
Bergen
Research Site
Bodø
Research Site
Elverum
Research Site
Fredrikstad
Research Site
Hamar
Research Site
Oslo
Research Site
Paradis
Research Site
Trondheim
Research Site
Tvedestrand

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Hungary8 sites

Research Site
Balatonfüred
Research Site
Budapest
Research Site
Gy¿r
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Miskolc
Research Site
Siófok
Research Site
Székesfehérvár

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Switzerland7 sites

Research Site
Bern
Research Site
Chur
Research Site
Ilanz
Research Site
Lausanne
Research Site
Monthey
Research Site
Sion
Research Site
Zurich

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Portugal6 sites

Research Site
Almada
Research Site
Amadora
Research Site
Caldas da Rainha
Research Site
Elvas
Research Site
Lisbon
Research Site
Portalegre

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Brazil5 sites

Research Site
Curitiba
Research Site
Fortaleza, Ceará
Research Site
Goiânia, Goiás
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
São Paulo, São Paulo

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India4 sites

Research Site
Bangalore
Research Site
Delhi
Research Site
India
Research Site
Mumbai, Mashatra

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South Africa4 sites

Research Site
Cape Town
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Durban
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Johannesburg
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Pretoria

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Taiwan4 sites

Research Site
Changhua
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Taichung
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Taipei
Research Site
Yongkang District, Tainan County

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Malaysia3 sites

Research Site
George Town
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Kuala Lumpur
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Petaling Jaya

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Philippines3 sites

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Cebu City
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Makati City
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Manila

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Russia3 sites

Research Site
Moscow
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Saint Petersburg
Research Site
Yaroslavl

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Hong Kong2 sites

Research Site
Hong Kong
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Shatin

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Indonesia2 sites

Research Site
Jakarta, DKI Jakarta
Research Site
Malang, East Java

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Singapore1 site

Research Site
Singapore

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About this study

Official title: A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin

This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)

Conditions: Type 2 Diabetes
Being tested: Tesaglitazar, Metformin, Fenofibrate
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
MetforminDrug
FenofibrateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

The change in HDL-C from baseline to the end of the randomized treatment period.

Secondary outcomes (8)

Changes in the following variables from baseline to the end of the randomized treatment period:
Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
Central obesity (waist/hip ratio)
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

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 posted5 Dec 2005 (estimated)
Study startMar 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: 1,000 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00261352
Sponsor's protocol ID: D6160C00003
Other IDs: EudraCT No 2004-02550-56
Status last verified: Apr 2009
First submitted: 1 Dec 2005
Last updated: 22 Apr 2009
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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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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All Type 2 Diabetes trials

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, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin
ClinicalTrials.gov ID: NCT00261352
Acronym / sponsor ID: D6160C00003
Conditions: Type 2 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The development program has been terminated
Enrolment: 1,000 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2005
Study completion: Dec 2006 (actual)
First posted: 5 Dec 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 (5 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
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), 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	–
Metformin	Drug	–
Fenofibrate	Drug	–

Primary outcome

The change in HDL-C from baseline to the end of the randomized treatment period.

8 secondary outcomes

Changes in the following variables from baseline to the end of the randomized treatment period:
Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
Central obesity (waist/hip ratio)
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

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.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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

152 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tesaglitazar, Metformin and Fenofibrate in people with Type 2 Diabetes, run by AstraZeneca at 152 sites in 18 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: 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 152 sites in France, Germany, Canada, Finland, Norway and 13 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?

The change in HDL-C from baseline to the end of the randomized treatment period.. 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 NCT00261352.

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; AzTrials last refreshed its copy on 7 Nov 2026.