Type 2 DiabetesPhase 3NCT00252837
GALLANT 22 Tesaglitazar vs. Placebo
A Phase 3 study testing Tesaglitazar and Dietary and Lifestyle counseling in people with Type 2 Diabetes, run by AstraZeneca at 101 sites in 14 countries.
Trial summary
This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 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 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tesaglitazar and Dietary and Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 475 participants
- Where
- 101 sitesin 14 countries
- Study dates
- Apr 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
- Drug-naïve (ie, no use of antidiabetic drug[s], for at least 24 weeks prior to visit 1).
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 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
101 sites in 14 countries.
101 sites in 14 countries
Poland19 sites
Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Gdansk
Research Site
Katowice, Ochojec
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Olsztyn
Research Site
Poznan
Research Site
Radom
Research Site
Rzeszów
Research Site
Sopot
Research Site
Szczecin
Research Site
Toruñ
Research Site
Tychy
Research Site
Warsaw
Research Site
Wroclaw
Research Site
Zabrze
Research Site
Zielona Góra
Norway11 sites
Research Site
Aursmoen
Research Site
Bergen
Research Site
Enebakk
Research Site
Fredrikstad
Research Site
Haugesund
Research Site
Hønefoss
Research Site
Inderøy
Research Site
Larvik
Research Site
Lierskogen
Research Site
Oslo
Research Site
Rolvsøy
Slovakia10 sites
Research Site
Dolný Kubín
Research Site
Levice
Research Site
Ľubochňa
Research Site
Lučenec
Research Site
Nové Zámky
Research Site
Považská Bystrica
Research Site
Šahy
Research Site
Trenčín
Research Site
Veľký Meder
Research Site
Žilina
Australia9 sites
Research Site
Adelaide
Research Site
Cairns
Research Site
Gosford
Research Site
Keswick
Research Site
Kippa-Ring
Research Site
Melbourne
Research Site
Miranda
Research Site
Nowra
Research Site
Wollongong
Czechia9 sites
Research Site
Brno
Research Site
Hodonín
Research Site
Hradec Králové
Research Site
Pilsen
Research Site
Prague
Research Site
Příbram
Research Site
Semily
Research Site
Tábor
Research Site
Ústí nad Labem
Sweden9 sites
Research Site
Åmål
Research Site
Borås
Research Site
Gothenburg
Research Site
Mölndal
Research Site
Partille
Research Site
Skene
Research Site
Stenungsund
Research Site
Uddevalla
Research Site
Vänersborg
France7 sites
Research Site
Angers
Research Site
Briollay
Research Site
Poitiers
Research Site
Saint-Benoît
Research Site
Saint-Ouen
Research Site
Toulouse
Research Site
Trélazé
Latvia7 sites
Research Site
Daugavpils
Research Site
Jēkabpils
Research Site
Madona
Research Site
Riga
Research Site
Sigulda
Research Site
Talsi
Research Site
Valmiera
Estonia5 sites
Research Site
Paide
Research Site
Pärnu
Research Site
Tallinn
Research Site
Tartu
Research Site
Viljandi
Hungary5 sites
Research Site
Balatonfüred
Research Site
Budapest
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Székesfehérvár
Lithuania4 sites
Research Site
Kaunas
Research Site
Klaipėda
Research Site
Panevezys
Research Site
Vilnius
Philippines3 sites
Research Site
Cebu City
Research Site
Pasig
Research Site
Quezon City
About this study
Official title: A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes
This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 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 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period.
The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.
- Conditions
- Type 2 Diabetes
- Being tested
- Tesaglitazar, Dietary and Lifestyle counseling
- 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
Dietary and Lifestyle 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 glycosylated hemoglobin A1c (HbA1c)
Secondary outcomes (14)
Changes in the following variables 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
Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Fibrinogen
Proportion of patients with microalbuminuria
Waist/hip ratio
Responder analyses for HbA1c, FPG, TG, HDL C, 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
Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startApr 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
- 475 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
- NCT00252837
- Sponsor's protocol ID
- D6160C00055
- Other IDs
- EudraCT No 2004-004374-90
- Status last verified
- Mar 2008
- First submitted
- 10 Nov 2005
- Last updated
- 17 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00252837
- Acronym / sponsor ID
- D6160C00055
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The development program has been terminated
- Enrolment
- 475 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Nov 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, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 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 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period.
The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical 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 (6 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 (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, 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 | – |
| Dietary and Lifestyle counseling | Behavioural | – |
Primary outcome
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
14 secondary outcomes
Changes in the following variables 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
Fasting plasma glucose (FPG), homeostasis assessment model, insulin, proinsulin, C-peptide
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Fibrinogen
Proportion of patients with microalbuminuria
Waist/hip ratio
Responder analyses for HbA1c, FPG, TG, HDL C, 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
Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Audit of Diabetes Dependent Quality of Life (ADDQoL). ADDQoL will only be applied in Poland.
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 17 Mar 2008.
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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
101 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tesaglitazar and Dietary and Lifestyle counseling in people with Type 2 Diabetes, run by AstraZeneca at 101 sites in 14 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 6 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 17 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in Poland, Norway, Slovakia, Australia, Czechia and 9 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?
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 17 Mar 2008.