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    Summary
    EudraCT Number:2004-001144-71
    Sponsor's Protocol Code Number:D6160C00032
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2004-001144-71
    A.3Full title of the trial
    A 24-Week Randomized, Double-Blind, Parallel-Group, 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 Sulphonylurea Alone
    Estudio aleatorizado de 24 semanas, doble ciego, de grupos paralelos, controlado con placebo, multicéntrico, para evaluar la eficacia, seguridad y tolerabilidad del tratamiento con Tesaglitazar cuando se añade al tratamiento de pacientes con Diabetes tipo 2 mal controlados con Sulfonilurea en monoterapia. GALLANT 7
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 24-Week Randomized, Double-Blind, Parallel-Group, 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 Sulphonylurea Alone
    Estudio aleatorizado de 24 semanas, doble ciego, de grupos paralelos, controlado con placebo, multicéntrico, para evaluar la eficacia, seguridad y tolerabilidad del tratamiento con Tesaglitazar cuando se añade al tratamiento de pacientes con Diabetes tipo 2 mal controlados con Sulfonilurea en monoterapia. GALLANT 7
    A.3.2Name or abbreviated title of the trial where available
    GALLANT 7
    GALLANT 7
    A.4.1Sponsor's protocol code numberD6160C00032
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support.
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointEsther Pascual
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034913019224.
    B.5.5Fax number0034913019625.
    B.5.6E-mailesther.pascual@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTesaglitazar
    D.3.2Product code AZ242
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESAGLITAZAR
    D.3.9.1CAS number 251565-85-2
    D.3.9.2Current sponsor codeAZ242
    D.3.9.3Other descriptive name.
    D.3.9.4EV Substance CodeSUB25217
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Calabren
    D.2.1.1.2Name of the Marketing Authorisation holderApplication Services Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlibenclamid
    D.3.2Product code .
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLIBENCLAMIDE
    D.3.9.1CAS number 10238-21-8
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive name.
    D.3.9.4EV Substance CodeSUB07916MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Diamicron
    D.2.1.1.2Name of the Marketing Authorisation holderServier
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGliclazide
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLICLAZIDE
    D.3.9.1CAS number 21187-98-4
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive name.
    D.3.9.4EV Substance CodeSUB07921MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number160 to 320
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Amaryl
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlimepiride
    D.3.2Product code -
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLIMEPIRIDE
    D.3.9.1CAS number 93479-97-1
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive name.
    D.3.9.4EV Substance CodeSUB07925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients diagnosed with type 2 diabetes and treated with a single or multiple oral antidiabetic agents
    Pacientes con diabetes tipo 2 en tratamiento con un agente antidiabético oral único o agentes orales múltiples.
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Diabetes tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of tesaglitazar (0.5 and 1 mg) as compared to placebo given as add-on therapy to sulphonylurea for 24 weeks in improving glycaemic control in patients with type 2 diabetes as determined by the absolute change in glycosylated haemoglobin A1c (HbA1c), from baseline to the end of the randomized treatment period.
    Valorar la eficacia de tesaglitazar (0,5 y 1 mg) comparado con placebo, como tratamiento añadido a una sulfonilurea durante 24 semanas, para mejorar el control glucémico en pacientes con diabetes tipo 2, mediante la determinación del cambio absoluto en la hemoglobina glucosilada (HbA1c) entre el valor basal y el final del periodo de tratamiento aleatorizado.
    E.2.2Secondary objectives of the trial
    To comp. the effects of TS 0.5 & 1mg vs placebo given as add-on therapy to SU in pat. with type 2 diabetes after a 24-w rand treatmt period: 1 On modif. lipids & lipoprot. Resp. rates & prop. of pat. reaching pre-specified target levels for TG, HDL C, non HDL C & LDL C. 2 On other mark of glycaemic ctrol inc. FPG & insulin. Resp rates & prop. of pat. achieving pre-specified target levels, for HbA1c & FPG. 3 On the level of risk mark. for cardiov. disease. 4 On adipose tissue hormones by evaluat. of adiponectin and leptin. 5 On waist-hip ratio. 6 To eval. the PK of TS (0.5 and 1 mg) as add-on therapy to SU. 7 To eval. the saf. & tol. of TS (0.5 and 1 mg) as add-on therapy to SU, by assessm. of AEs, lab. values, ECG, pulse, BP, hypoglycaemic ev, body weight, cardiac evaluation & phys exam.
    Comp los efectos de TS 0,5 y 1mg vs placebo, administ como tto añadido a una SU, en la modific. de lípidos y lipoproteínas en ptes con diabetes T 2, al cabo de 24 sem. de tto aleatorizado: 1. en el cambio de las variab. lipídicas y lipoproteínicas. Las tasas de resp. y prop. de ptes que alcancen un cambio preespecificado en TG, C-HDL, C-no HDL y C-LDL. 2. Otros marc. del ctrol glucém. inc. GPA e insulina. Tasas de resp. y prop. de ptes que alcancen unos niveles diana preespecificados de HbA1c y GPA. 3. Sobre nivel de marc. de riesgo de cardiop. 4. Sobre las hormonas del tejido adiposo mediante la eval. de adiponectina y leptina. 5. En el índice cintura-cadera. 6. Evaluar la FC de TS (0,5 y 1 mg) como tto añadido a una SU. 7. Evaluar la seg. y la tolerab. de TS (0,5 y 1 mg) como tto añadido a una SU, mediante la val. de AAs, valores analíticos, ECG, frec. cardiaca, p. arterial, acont. hipoglucém., peso, eval. cardiacas y explor. físicas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria at enrolment (visit 1): 1. Provision of a written informed consent at visit 1. 2. Men or women who are older than or 18 years of age at time of consenting upon visit 1. 3. Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control. Post menopausal patients are defined as patients with: Natural or induced menopause with last menstruation >1 year ago, or bilateral oophorectomy. Reliable birth control is defined as double barrier method (condom with spermicide, diaphragm with spermicide), oral contraceptive, implant, long term injectable contraceptive, intrauterine device, or tubal ligation. However, female patients using oestrogen containing hormonal anti conception methods (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional barrier method for contraception (condom or diaphragm). 4. Diagnosed with type 2 diabetes. 5. Treated with a single or multiple oral antidiabetic agents. Inclusion criteria at start of sulphonylurea titration (visit 2, lab values from visit 1): 6. HbA1c higher than or equal to 7% if previously on monotherapy. 7. HbA1c lower than or equal to 10%. 8. FPG lower than or equal to 13.3 mmol/L (240 mg/dL). Inclusion criteria at randomization (visit 7, lab values from visits 5 and 6): 9. Predefined daily dose of sulphonylurea: glibenclamide 10?15 mg, gliclazide 160 320 mg, glimepiride 3-6 mg or glipizide 10-20 mg. 10. HbA1c higher than or equal to 7% and lower than or equal to 10% (laboratory value from visit 6). 11. Mean FPG of two measurements (laboratory values from visit 5 and 6) higher than or equal to 7.0 mmol/L (126 mg/dL) and lower than or equal to 11.7 mmol/L (210 mg/dL).
    Criterios de inclusión para el reclutamiento (visita 1):
    1. Dar el consentimiento informado escrito en la visita 1. 2. Hombres o mujeres de edad mayor a 18 años en el momento del consentimiento durante la visita 1
    3. Mujeres postmenopáusicas, histerectomizadas o en edad fértil que utilicen un método anticonceptivo fiable. Las pacientes posmenopáusicas se definen como pacientes con: Menopausia natural o inducida que hayan presentado la última menstruación hace >1 año, u Ooforectomía bilateral. Una anticoncepción fiable se define como un método de doble barrera (preservativos con espermicida, diafragma con espermicida), contraceptivo oral, implante, anticonceptivo inyectable de larga duración, dispositivo intrauterino o ligadura de trompas. Sin embargo, las pacientes que estén usando un método anticonceptivo hormonal que contenga estrógenos (oral, transdérmico, anillo vaginal o una combinación de inyectables) debe usar un método anticonceptivo adicional de barrera (preservativo o diafragma). 4. Diagnóstico de diabetes tipo 2. 5. Tratamiento con cualquier agente antidiabético oral único o agentes orales múltiples.
    Criterios de inclusión al comienzo del titulación de sulfonilurea (visita 2, valores de laboratorio de la visita 1):
    6. HbA1c mayor o igual a 7% si previamente en monoterapia. 7. HbA1c menor o igual a 10%. 8. GPA menor o igual a 13,3 mmol/L (240 mg/dL).
    Criterios de inclusión en la aleatorización (visita 7, valores de laboratorio de las visitas 5 y 6):
    9. Dosis diaria predefinida de sulfonilurea: glibenclamida 10?15 mg, gliclazida 160 320 mg, glimepirida 3-6 mg o glipizida 10-20 mg. 10. HbA1c mayor o igual a 7% y menor o igual a 10% (valor de laboratorio de la visita 6). 11. Media de dos determinaciones de GPA (valores de laboratorio de las visitas 5 y 6) mayor o igual a 7.0 mmol/L (126 mg/dL) y menor o igual a 11,7 mmol/L (210 mg/dL).
    E.4Principal exclusion criteria
    Exclusion criteria at enrolment (visit 1): 1. Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes. 2. Active arterial disease such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular accident, myocardial or peripheral vascular disease revascularization or angioplasty within 24 weeks prior to visit 1. 3. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. 4. History of thyroid ophthalmopathy. 5. History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma. 6. History of blood lipid induced eruptive xanthomas or hypertriglyceridaemia induced pancreatitis. 7. Pregnant or breastfeeding patients. 8. Suspicion that the patient is infected according to World Health Organisation (WHO) risk categories 2 to 4. 9. Treatment with chronic insulin, within 24 weeks prior to visit 1 (however, one temporary period of daily insulin injections no longer than 7 days is allowed). 10. Treatment with a thiazolidinedione within 4 weeks prior to visit 1. 11. Treatment with fibrates, within 4 weeks prior to visit 1. 12. Treatment with glucocorticoids (equivalent to oral prednisolon >10 mg per day), within 4 weeks prior to visit 1. 13. Treatment with probenecid that can not be stopped at visit 1. 14. History of hypersensitivity or intolerance to any PPAR agonist. 15. Intolerance to sulphonylurea at any time in the past, or pre-existing medical conditions that is contraindicated for the use of sulphonylurea. 16. History of drug-induced myopathy or drug-induced CK elevation. 17. History of drug-induced liver enzyme elevations. 18. History of drug-induced neutropenia. 19. History of alcohol or drug abuse within the last 5 years. 20. Other serious or unstable medical or psychological condition identified in the patients? medical history that, in the judgement of the investigator, would compromise the patients? safety or successful participation in the Clinical Study. 21. Receiving any investigational product within 12 weeks (90 days for UK) prior to visit 1. 22. Previous enrolment in this study. Exclusion criteria at start of sulphonylurea titration (visit 2, lab values from visit 1): 23. Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgement of the investigator would compromise the patients? safety or successful participation in the Clinical Study. 24. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. 25. Fasting TG higher than 7.0 mmol/L (620) mg/dL. 26. Hb lower than 90 g/L (9 g/dL). 27. ANC lower than 1.0 x 10E9/L. 28. Any of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) more than 2.5 times the upper limit of normal. 29. Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert?s syndrome. 30. Creatinine more than 2 times the upper limit of normal. 31. CK more than 3 times the upper limit of normal. Exclusion criteria at randomization (visit 7, lab values from visit 6): 32. Any clinically significant abnormality identified on physical examinations, laboratory tests or ECG, which in the judgement of the investigator would compromise the patients? safety or successful participation in the Clinical Study. 33. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. 34. Other serious or unstable medical or psychological condition identified in the patients? medical history that, in the judgement of the investigator, would compromise the patients? safety or successful participation in the Clinical Study. 35. High blood pressure (mean diastolic blood pressure higher than 120 mm Hg) or malignant hypertension. 36. Hb lower than 90 g/L (9 g/dL). 37. ANC lower than 1.0 x 10E9/L. 38. Any of ALT, AST or ALP more than 2.5 times the upper limit of normal. 39. Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert?s syndrome. 40. Creatinine more than 2 times the upper limit of normal. 41. CK more than 3 times the upper limit of normal.
    Criterios de exclusión en el reclutamiento (visita 1):
    1. Diabetes tipo 1, antecedentes de cetoacidosis diabética o diabetes tipo 2 inducida por corticoesteroides. 2. Enfermedad arterial activa, como angina de pecho inestable, infarto de miocardio, episodio isquémico transitorio, accidente cerebrovascular, revascularización o angioplastia de enfermedad vascular miocárdica o periférica en las 24 semanas previas a la visita 1. 3. Insuficiencia cardiaca clase III o IV de la NYHA o inestable de Clase I o II, a juicio del investigador. 4. Antecedentes de oftalmopatía tiroidea. 5. Antecedentes de patología maligna en los últimos 5 años, excluyendo el tratamiento exitoso de carcinoma basocelular o de células escamosas. 6. Antecedentes de xantomas eruptivos inducidos por lípidos en sangre o pancreatitis inducida por hipertrigliceridemia. 7. Pacientes embarazadas o en periodo de lactancia. 8. Sospecha de infección del paciente perteneciente a las categorías de riesgo 2 a 4 de la OMS. 9. Tratamiento con insulina de forma crónica dentro de las 24 semanas anteriores a la visita 1 (no obstante, se permite un periodo transitorio de inyecciones diarias de insulina no superior a 7 días). 10. Tratamiento con tiazolidinediona en las 4 semanas previas a la visita 1. 11. Tratamiento con fibratos, en las 4 semanas previas a la visita 1. 12. Tratamiento con glucocorticoides (equivalentes a prednisolona oral >10 mg al día) en las 4 semanas anteriores a la visita 1. 13. Tratamiento con probenecid que no se pueda interrumpir en la visita 1. 14. Antecedentes de hipersensibilidad o intolerancia a cualquier agonista PPAR. 15. Intolerancia a sulfonilureas en cualquier momento del pasado, o procesos médicos pre-existentes que contraindiquen su uso. 16. Antecedentes de miopatía inducida por fármacos o elevación de CK inducida por fármaco. 17. Antecedentes de elevaciones de enzimas hepáticas inducidas por fármacos. 18. Antecedentes de neutropenia inducida por fármacos. 19. Antecedentes de consumo abusivo de alcohol o drogas en los últimos 5 años. 20. Cualquier afección médica grave o inestable o afección psicológica identificada en la historia clínica de los pacientes que, a juicio del investigador, pudiera comprometer la seguridad de los pacientes o una participación satisfactoria en el Estudio Clínico. 21. Administración de algún producto en investigación en las 12 semanas (90 días para el Reino Unido) previas a la visita 1. 22. Reclutamiento anterior en este estudio
    Criterios de exclusión al comienzo de la titulación de sulfonilurea (visita 2, valores de laboratorio de la visita 1):
    23. Cualquier anomalía clínicamente significativa identificada durante la exploración física, en las pruebas de laboratorio o el ECG que, a juicio del investigador, pudiera comprometer la seguridad de los pacientes o su participación satisfactoria en el Estudio Clínico. 24. Insuficiencia cardiaca de Clase NYHA III o IV, o de Clase I o II inestable a juicio del investigador. 25. TG en ayunas >7,0 mmol/L, 620 mg/dL. 26. Hb > 90 g/L, 9 g/dL. 27. RAN >1,0x 109/L. 28. Alanina aminotransferasa (ALT), aspartato aminotransferasa (AST) o fosfatasa alcalina (FA) >2,5 veces el límite superior de normalidad. 29. Bilirrubina total superior al límite superior de normalidad salvo que sea exclusivamente el resultado del síndrome de Gilbert. 30. Creatinina >2 veces el límite superior de normalidad. 31. CK >3 veces el límite superior de normalidad.
    Criterios de exclusión en el momento de la aleatorización (visita 7, valores de laboratorio de la visita 6):
    32. Cualquier anomalía clínicamente significativa identificada durante la exploración física, en las pruebas de laboratorio o el ECG que, a juicio del investigador, pudiera comprometer la seguridad de los pacientes o su participación satisfactoria en el Estudio Clínico. 33. Insuficiencia cardiaca de Clase NYHA III o IV, o inestable de Clase I o II a juicio del investigador. 34. Cualquier afección médica grave o inestable o afección psicológica identificada en la historia clínica de los pacientes que, a juicio del investigador, pudiera comprometer la seguridad de los pacientes o una participación satisfactoria en el Estudio Clínico. 35. Presión arterial elevada (presión arterial diastólica media >120 mm Hg) o hipertensión maligna. 36. Hb <90 g/L (9 g/dL). 37. RAN <1,0x 109/L. 38. ALT, AST o FA >2,5 veces al límite superior de normalidad. 39. Bilirrubina total superior al límiter superior de normalidad salvo que sea exclusivamente el resultado del síndrome de Gilbert. 40. Creatinina >2 veces el límite superior de normalidad. 41. CK >3 veces el límite superior de normalidad.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is the absolute change from baseline to end of the randomized treatment period (24 weeks) in HbA1c.
    La variable principal es el cambio absoluto con respecto a la HbA1c basal al cabo de 24 semanas de tratamiento aleatorizado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks from baseline
    24 semanas desde el momento basal
    E.5.2Secondary end point(s)
    Changes in the following variables:
    - Lipid parameters (TG, total cholesterol (TC), HDL C, non HDL C, LDL C, apolipoproteins (Apo) A I and Apo B),
    - C-reactive protein (CRP), LDL C/HDL C ratio and Apo B/Apo A I ratio,
    - FPG and insulin,
    - Waist-hip ratio,
    - Leptin and adiponectin.
    Cambios en las variables siguientes:
    - Parámetros lipídicos (TG, colesterol total (CT), C-HDL, C-no HDL, C-LDL, apolipoproteínas (Apo) A I y Apo B),
    - Proteína C-reactiva (PCR), índice C-LDL/C-HDL e índice Apo B/Apo A I,
    - GPA e insulina,
    - Índice cintura-cadera,
    - Leptina y adiponectina
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks from baseline
    24 semanas desde el momento basal
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    France
    Israel
    Korea, Republic of
    Norway
    Philippines
    South Africa
    Spain
    United Kingdom
    Vietnam
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study is expected to start in Q3 2004 (ie, planned enrolment of first patient), and to be completed by Q1 2006 (ie, planned last treatment of last patient). End of study is definied as date of database lock, which is the time point after which no patient will be exposed to study related activities. The date of planned database lock is Q2 2006.
    Se prevé que el estudio comience en en el 3er trimestre de 2004 (reclutamiento del primer paciente) y finalice en el 1er trimestre de 2006 (último tratamiento previsto del último paciente). El final del estudio se define como la fecha del cierre de la base de datos, momento a partir del cual ningún paciente será expuesto a ninguna actividad relacionada con estudio. La fecha prevista para el cierre de la base de datos es 2º trimestre de 2006.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9999
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9999
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 555
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Applicable patients will be transferred to a long-term extension study at the end of the randomized treatment period (visit 13). The follow-up visit (visit 14) should not be done.
    Aquellos pacientes elegibles que lo deseen serán transferidos al estudio de extensión a largo plazo al final del periodo de tratamiento aleatorizado (visita 13). No se llevará a cabo la visita de seguimiento (visita 14)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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