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    Summary
    EudraCT Number:2013-000418-39
    Sponsor's Protocol Code Number:EPREDICE2013
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-12-19
    Trial 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 ConcernedLithuania - SMCA
    A.2EudraCT number2013-000418-39
    A.3Full title of the trial
    Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe
    Ankstyvoji cukrinio diabeto komplikacijų profilaktika Europoje žmonėms, kuriems nustatytas padidėjęs gliukozės kiekis kraujyje.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Early Prevention of Diabetes Complications in people with Pre-Diabetes in Europe
    Ankstyvoji cukrinio diabeto komplikacijų profilaktika Europoje žmonėms, kuriems nustatytas padidėjęs gliukozės kiekis kraujyje.
    A.3.2Name or abbreviated title of the trial where available
    e-PREDICE
    A.4.1Sponsor's protocol code numberEPREDICE2013
    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 SponsorFUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES (FIRCAVA)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Commission FP7
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES (FIRCAVA)
    B.5.2Functional name of contact pointJaakko Tuomilehto
    B.5.3 Address:
    B.5.3.1Street AddressAvda. de Europa 19, Parque Empresarial La Moraleja,
    B.5.3.2Town/ cityAlcobendas/Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917932244
    B.5.6E-mailjaakko@ceiis.org
    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 Yes
    D.2.1.1.1Trade name Glucophage 850 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sante s.a.s.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGLUCOPHAGE/GLUCOPHAGE FORTE/DIANBEN/RISIDON 850 mg film-coated tablet
    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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 657-24-9
    D.3.9.3Other descriptive nameMETFORMIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 Trajenta 5 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNLinagliptin
    D.3.9.1CAS number 668270-12-0
    D.3.9.3Other descriptive nameLINAGLIPTIN
    D.3.9.4EV Substance CodeSUB31340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Jentadueto 2.5 mg/850 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNMETFORMIN
    D.3.9.1CAS number 657-24-9
    D.3.9.3Other descriptive nameMETFORMIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinagliptin
    D.3.9.1CAS number 668270-12-0
    D.3.9.3Other descriptive nameLINAGLIPTIN
    D.3.9.4EV Substance CodeSUB31340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Non diabetic hyperglycaemia:
    Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or both
    Prediabetas t.y. ne diabetinio lygmens hiperglikemija (sutrikusi glikemija nevalgius (SGN) ar gliukozės tolerancijos sutrikimas (GTS) arba abu sutrikimai kartu.
    E.1.1.1Medical condition in easily understood language
    Pre-Diabetes
    Pre-diabetas
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10065542
    E.1.2Term Prediabetes
    E.1.2System Organ Class 100000004861
    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 effect of treatment with linagliptin, metformin or the combination of linagliptin with metformin, plus lifestyle intervention (diet and physical activity), compared to lifestyle intervention alone, for at least 3 years, and up to 5 years, on different microvascular parameters (retinal, renal and neurological), as defined by the primary and secondary endpoints, in adults with non diabetic hyperglycaemia (IGT, IFG or IFG plus IGT).
    Įvertinti gydymo metforminu, linagliptinu ar jų kombinacija kartu su gyvensenos keitimu efektyvumą mikrovaskulinių komplikacijų (tokių kaip retinopatija, nefropatija, neuropatija) vystymuisi 3-5 metų laikotarpiu lyginant tik su gyvensenos keitimu, asmenims, kuriems diagnozuota GTS, SGN ar abu sutrikimai.
    E.2.2Secondary objectives of the trial
    1-To identify among people with hyperglycaemia who are most likely to develop early diabetic complication.
    2-To determine the extent to which the compliance to the interventions affect the rate on early diabetic complications prevention
    3-To evaluate the effect of the different treatment regimes applied in this study on quality of life and neuropsychological functions
    4-To assess the efficacy of treatment with linagliptin, metformin and the combination of linagliptin with metformin plus lifestyle intervention in comparison to lifestyle intervention alone with regard to surrogate parameters of vascular function and structure, and novel biomarkers of microvascular damage in adults with non-diabetic hyperglycaemia (IGT, IFG or IFG plus IGT)
    5-To determine the safety of linagliptin, metformin and of the combination of linagliptin with metformin plus lifestyle intervention in people with non diabetic hyperglycaemia with regard to severe adverse effects and clinically important events
    1. Nustatyti asmenis, kuriems yra didžiausia tikimybė kad išsivystys ankstyvos diabeto komplikacijos.
    2. Išaiškinti, kurios intervencijos laikymasis labiausiai įtakoja prevenciją ankstyvoms diabetinėms komplikacijoms.
    3. Įvertinti skirtingų gydymo metodų įtaką yvenimo kokybei ir neuropsichologinėms funkcijoms.
    4.Įvertinti gydymo linagliptinu, metforminu ir linagliptino bei metformino deriniu kartu su su gyvenimo būdo intervencija įtaką kraujagyslių funkcijai ir struktūrai bei naujų mikrokraujagyslinių komplikacijų biologiniiams žymenims asmenims , kuriems patvirtintas pre-diabetas, lyginant tik su gyvenimo būdo intervencijos taikymu.
    5.Nustatyti linagliptino, metformino ir linagliptino bei metformino derinio, drauge su gyvenimo būdo intervencijos, saugumą, vertinant pagal nepageidaujamas reakcijas ir kliniškai svarbius įvykius.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men and women
    - Age 45 -74 years
    - Impaired Fasting Glucose (IFG): FPG 6.1 to 6.9mmol/l and 2-h PG <7.8mmol/L; or Impaired Glucose Tolerance (IGT): FPG <7.0mmol/L and 2h PG >_7.8 and <11.1 mmol/L; or both conditions;
    - Informed consent given
    •Vyrai ir moterys
    •45-74 metų amžiaus
    •Sutrikusi glikemija nevalgius (SGN): nevalgius 6,1 - 6,9 mmol/l ir 2 val. po krūvio (valgio)<7,8mmol/L; arba sutrikusi gliukozės tolerancija (GTS): nevalgius <7,0mmol/L ir 2 val. po krūvio (valgio)>7,8 ir <11,1 mmol/L; arba abu sutrikimai;
    •Tiriamasis sutinka dalyvauti tyrime, pasirašydamas informuoto asmens sutikimo formą
    E.4Principal exclusion criteria
    - Type 1 diabetes.
    - Known* or unknown T2D (including screen detected T2D) with or without pharmacological treatment.
    - Use of a GLP-1 receptor agonist (exenatide or other) or pramlintide or any dipeptidyl peptidase-4 (DPP-4) inhibitor or metformin within the 3 months prior to enrolment.
    - Use of insulin or long-acting insulin analogue within 3 months prior to enrolment
    - Any previous cardiovascular or cerebrovascular clinically documented event or revascularization procedure
    - Clinical Evidence of macro-vascular complications (overt clinical cardiovascular disease) at enrolment, including angina (stable or unstable) and evidence or previous myocardial infarction in baselina EKG.
    - Current renal replacement therapy
    - Previous diagnosis of liver cirrhosis or chronic hepatitis*, or an elevation of liver enzymes (AST and or AST) >3 times normal ranges
    - Previous diagnosis of Chronic Heart Failure (NYHA class III or higher)
    - A prior solid organ transplant or waiting for organ transplant
    - Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen?s disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are allowed to enter the trial
    - Any acute condition or exacerbation of chronic condition that would in the Investigator's opinion interfere with the initial trial visit schedule and procedures
    - Known or suspected hypersensitivity to trial products or related products
    - Known use of non prescribed narcotics or illicit drugs.
    - Simultaneous participation in any other clinical trial of an investigational agent.
    - Females of childbearing potential who are pregnant (all fertile women will be tested for before randomization), breast-feeding or intend to become pregnant.
    - Presence of cataract that impedes the retinal evaluation of both eyes
    - Other previously diagnosed retinal diseases
    - Any diseases that would prevent the measurement of primary endpoints
    - Dementia, mental disorder or evident cognitive impairment unable to give informed consent
    - End-stage or metastatic cancer
    - Institutionalization
    - Renal function impairment: GFR <60 ml/min/1.73m2
    - Contraindication to any of the study drugs (metformin or linagliptin). This includes: ALT > 3 times the upper limit of normal, history of cirrhosis or hepatitis, suspected renal artery stenosis, recent gastrointestinal bleeding (within the last year), pregnant, breastfeeding or a female of child-bearing potential not on reliable contraception and also any circumstance where ongoing medication might lead to potential adverse drug interaction with components of the trial medications.
    - Any other reason, medical condition, ongoing medication or significant disability that would prevent the participant complying with trial consent, treatment and follow-up procedures or potentially jeopardise her/his medical care.
    * Previous diagnosis should be documented after medical record review
    • Diagnozuotas 1 tipo cukrinis diabetas.
    • Diagnozuotas 2 tipo cukrinis diabetas (įskaitant ir nustatytą atrankos vizito metu) nepriklausomai nuo to netaikomas medikamentinis gydymas, ar ne.
    • GLP-1 receptorių agonistų ar pramlintido ar bet kurio dipetidilpeptidazės 4 (DPP-4) inhibitorių ar metformino vartojimas per paskutinius 3 mėnesius iki įtraukimo į tyrimą.
    • Insulino ar ilgo veikimo insulino analogų vartojimas per paskutinius 3 mėnesius iki įtraukimo į tyrimą.
    • Bet koks ankstesnis kardiovaskulinis ar cerebrovaskulinis kliniškai dokumentuotas atvejis ar revaskuliarizacijos procedūra*.
    • Kliniškai patvirtinta makrovaskulinė komplikacija (akivaizdi kardiovaskulinė liga) įtraukimo metu, įskaitant krūtinės anginą (stabilią ar nestabilią) ir ankščiau buvusį miokardo infarktą, patvirtintą pradinėje EKG.
    • Taikoma pakaitinė inkstų terapija.
    • Ankščiau diagnozuota kepenų cirozė ar lėtinis hepatitas*, ar daugiau kaip 3 kartus virš normos ribos padidėję kepenų fermentai (ALTar AST)
    • Ankščiau diagnozuota lėtinė širdies liga (III ar aukštesnė NYHA kl.)
    • Atlikta vidaus organų transplantacija arba planuojama.
    • Piktybinis susirgimas, po taikyto chirurginio gydymo, chemoterapijos, radioterapijos ar paliatyvios terapijos per pastaruosius 5 metus. Asmenims su intraepiteline plokščialąsteline odos karcinoma (Bowen’o liga), skiriant 5-fluorouracilą (5FU) vietiškai ir asmenims su bazinių odos ląstelių vėžiu yra leidžiama dalyvauti klinikiniame tyrime.
    • Bet kokia ūminė būklė ar lėtinės ligos paūmėjimas, tyrėjo nuomone, galintis trukdyti pradinio bandomojo vizito darbotvarkę ir procedūras.
    • Žinomas ar įtariamas jautrumas klinikinio tyrimo bandomiems produktams ar susijusiems produktams.
    • narkotinių medžaigų vartojimas ar priklasomybė vaistams.
    • Dalyvavimas kitame klinikiniame tyrime.
    • Nėštumas, maitinimas krūtimi ar ketinimas pastoti. (Visos moterys, vaisingo amžiaus, bus tikrinamos dėl galimo neštumo iki randomizacijos)
    • Katarakta, trukdanti abiejų akių tinklainės įvertinimui. Operuotiems dėl kataraktos leidžiama dalyvauti, jei jie pilnai pasveiko nuo jos.
    • Diagnozuotos kitos tinklainės ligos.
    • Bet kokios kitos ligos, trikdančios pagrindinių duomenų vertinimą
    • Demencija, psichinis sutrikimas ar akivaizdus kognityvinis sutrikimas, dėl ko negalima būtų duoti informuoto asmens sutikimo formos.
    • Išeičių stadijos arba metastazavęs vėžys.
    • Gyvenantys slaugos namuose, kalėjime
    • Inkstų funkcijos sutrikimas: GFG <60 ml/min/1.73m2.
    • Kontraindikacija bet kokiam klinikinio tyrimo metu skiriamam medikamentui (metforminui ar sitagliptinui). Tai yra: ALT >3 kartus padidėjęs nei viršutinė normos riba, kepenų cirozė ar hepatitas, įtariama inkstų arterijos stenozė, nesenas (per praėjusius metus) kraujavimas iš skrandžio ar žarnyno, nėštumas, maitinimas krūtimi, vaisingo amžiaus moteris, vartojanti nepatikimą kontracepciją ir taip pat bet kokios aplinkybės, dėl kurių nuolatinis vaistų vartojimas kartu su klinikinio tyrimo metu skiriamais vaistais gali sąlygoti nepageidaujamą tarpusavio sąveiką.
    • Bet kokia kita priežastis, medicininė būklė, vartojami vaistai ar akivaizdi negalia, neleidžianti laikytis klinikinio tyrimo susitarimo, gydymo ir tolimesnio stebėjimo procedūrų ar galimai kelti grėsmę jo/jos sveikatai.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a combined continuous variable: the microvascular complication índex" (MCI) composed by a linear combination of the Early Treatment Diabetic Retinopathy Study Scale (ETDRS) score, the level of urinary albumin to creatinine ratio, and sudomotor test (SUDOSCAN) score, measured during the 36th and 60th month visits
    Pagrinidnis vertinimo rodiklis bus mikrokraujagyslinių komplikacijų indeksas, kurį sudaro dedamosios Diabetinės Retinopatijos Ankstyvo Gydymo Studijos (DRAGS) skalės, albumino ir kreatinino santykio šlapime lygmens ir sudomotorinės funkcijos (SUDOSCAN) lygmuo, įvertinti vizitų 36 ir 60 mėn. metu.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 and 60 months after randomization
    36 ir 60 mėnuo
    E.5.2Secondary end point(s)
    - Retinopathy score at last visit defined as 2 steps progression on the ETDRS scale between baseline and visits at months 36th and 60th
    - One standard deviation (SD) increase on the level of urinary albumin to creatinine ratio between baseline and visits at months 36th and 60th
    - One SD decrease Changes in the level of hands and feet conductance in SUDOSCAN between baseline and visits at months 36th and 60th
    - Change in microvascular endothelial function (MEF) measured by the Endo-PAT method (in a subset).
    - Change in the Non-Alcoholic Fatty Liver (NAFL) Index (in a subset).
    - Change in biomarkers of microvascular damage, endothelial function, per-oxidation, inflammation, and metabolomics (in a subset).
    - Change in the insulin secretion and beta-cell function
    - Change in self-perceived Quality of Life (QoL).
    - Change in symptoms of peripheral neuropathy
    - Change in neuropsychological parameters: cognitive function, and depressive symptoms and indices.
    - Changes in Obstructive Sleep Apnoea (OSA) indices as measured by Somnomedics.(in a subset)
    - Changes in ambulatory blood pressure monitoring (in a subset)
    - Change in the mean common carotid intimae-media thickness (CIMT) (in a subset).
    - Incidence of major cardiovascular events, defined as an expanded composite of total coronary events, total stroke events, revascularization procedures (coronary artery bypass graft, percutaneous coronary angioplasty, and peripheral revascularization), hospitalization for heart failure, transient ischemic attack, and cardiovascular or cerebrovascular death
    •Retinopatijos rezultatas galutiniame vizite apibrėžtas kaip 2 progrseijos laipsniai vertinant pagal DRAGS skalę tarp pradinio vizito ir 36 bei 60 mėnesio vizitų.
    •Albumino ir kreatinino santykio šlapime lygio padidėjimas vienas SN tarp pradinio vizito ir 36 bei 60 mėnesio vizitų.
    •Rankų ir kojų laidumo lygio, matuojant SUDOSCAN, pakitimų sumažėjimas 1vienas SN tarp pradinio vizito ir 36 bei 60 mėnesio.
    • Mikrokraujagyslių endotelio funkcijos (MEF) pakitimai išmatuoti EndoPAT metodu (sub- tyrimas).
    • Suriebėjusių kepenų ligos indekso pasikeitimas (pogrupyje).
    • Obstrukcinės Miego Apnėjos (OMA) indekso pasikeitimai (sub- tyrimas) išmatuoti Somnomedics.
    •Arterinio kraujo spaudimo pasikeitimai matuojant ambulatoriškai (sub- tyrimas).
    •Bendrosios miego arterijos intimos storio (MAIS) vidurkio pasikeitimas (pogrupyje).
    • Mikrokraujagyslių pažeidimo, endotelio funkcijos, peroksidacijos, uždegimo ir metabolitų biologinių žymenų pasikeitimas (sub- tyrimas).
    • Insulino sekrecijos ir β ląstelės funkcijos pasikeitimas.
    •Gyvenimo kokybės pasikeitimas.
    •Periferinės neuropatijos simptomų pasikeitimas.
    •Neuropsichologinių parametrų, kognityvinės funkcijos, nerimo ir depresijos simptomų, pasikeitimas.
    •Didieji kardiovaskuliniai įvykiai ir kardiovaskulinės mirtys.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 and 60 months
    30 ir 60 mėnuo
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Gyvensenimo būdo keitimas
    Lifestyle intervention
    E.8.2.4Number of treatment arms in the trial4
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    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
    Austria
    Bulgaria
    Germany
    Greece
    Italy
    Lithuania
    Poland
    Serbia
    Spain
    Switzerland
    Turkey
    E.8.7Trial has a data monitoring committee Yes
    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
    Last Visit Last Subject (LVLS)
    Paskutinis paskutinio tiriamojo vizitas
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 2500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2400
    F.4.2.2In the whole clinical trial 3000
    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)
    None
    Gydymas nenumatytas.
    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 Decision2015-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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