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    Summary
    EudraCT Number:2020-002712-51
    Sponsor's Protocol Code Number:2020
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-23
    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 ConcernedFinland - Fimea
    A.2EudraCT number2020-002712-51
    A.3Full title of the trial
    Semaglutide as an adjunct to dieting in the treatment of type 2 diabetes – effects on glucose metabolism, prevention of weight regain and peripheral tissue metabolic activation
    Kliininen lääketutkimus, jossa selvitetään semaglutidin vaikutusta laihdutuksen tukena glukoositasapainoon, painonhallintaan ja kudosten aineenvaihduntaan tyypin 2 diabetesta sairastavilla lumelääkkeeseen verrattuna
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Semaglutide in the treatment of type 2 diabetes – effects on prevention of weight regain and metabolism after diet induced weight loss
    Semaglutidi laihdutuksen tukena tyypin 2 diabeteksen hoidossa - vaikutukset verensokeriin, painoon ja kehon aineenvaihduntaan
    A.4.1Sponsor's protocol code number2020
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1257-6747
    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 SponsorKirsi Pietiläinen
    B.1.3.4CountryFinland
    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 supportNovo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNovo Nordisk
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationObesity Research Unit / Lihavuustutkimusyksikkö
    B.5.2Functional name of contact pointLihavuustutkimusyksikkö
    B.5.3 Address:
    B.5.3.1Street AddressHaartmaninkatu 8
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00290
    B.5.3.4CountryFinland
    B.5.6E-maillihavuustutkimusyksikko@gmail.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 Yes
    D.2.1.1.1Trade name Ozempic
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk 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.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes
    Tyypin 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Tyypin 2 diabetes
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to investigate the effect of semaglutide 1.34mg/ml treatment compared with placebo treatment on glucose homeostasis (HbA1c) in patients with T2DM following diet-induced weight loss intervention at 12 months.
    E.2.2Secondary objectives of the trial
    The effects of semaglutide 1.34mg/ml compared with placebo:
    -on weight maintenance following diet-induced weight loss intervention at 12 months (body weight,adiposity-related measures)
    -on metabolic parameters (liver fat,blood pressure,lipids) following diet-induced weight loss intervention at 12 months
    -on appetite and eating habits using questionnaires Control of Eating,Binge Eating Scale,Dutch Eating Behaviour Questionnaire,Questionnaire on Eating and Weight Patterns
    -on adipose tissue and skeletal muscle metabolism and mitochondrial parameters following diet-induced weight loss intervention at 12 months
    -n oxygen uptake and perfusion-proxy measures of mitochondrial function-of tissues (subcutaneous and intra-abdominal adipose tissue,brown adipose tissue,skeletal muscle,gut and liver) using a PET and CT scanning before vs. after diet-induced weight loss intervention at 12 months
    -the differences of the above measures between patients with T2DM and healthy controls at baseline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for the group of type 2 diabetes
    - Age ≥18 years and <65 years
    - BMI: ≥27 kg/m2
    - T2DM (HbA1c ≥ 6% if on anti-diabetic medication or HbA1c ≥6.5% if non-medicated)
    - Participant is willing and able to give informed consent for participation in the study

    Inclusion criteria for the control group
    - Age ≥18 years and <65 years
    - BMI <25 kg/m2
    - participants willing and able to give informed consent for participation in the study
    E.4Principal exclusion criteria
    Exclusion criteria for the group of type 2 diabetes
    -Contraindication to trial drugs
    - Use of insulin or GLP-1RAs (during the past 3 months)
    - Use of anti-obesity drugs (during the past 3 months)
    - Weight change of >5% during the past 3 months
    - Bariatric surgery or planned bariatric surgery during the trial
    - History of pancreatitis
    - Impaired renal function (GFR<30 ml/min/1.73m2)
    - Impaired hepatic function (ALAT>2 x upper limit normal)
    - Clinically significant active cardiovascular disease
    - Clinically significant abnormality in the ECG
    - Cancer (except basal or squamous cell skin cancers)
    - Major psychiatric disease (such as severe depression, bipolar disorder, schizophrenia)
    - Substance abuse
    - Learning disability
    - Females of childbearing potential not using adequate contraceptive methods
    - Pregnancy
    - Lactation
    - Any other condition that in the opinion of the investigator could interfere with the conduction of the study or interpretation of the study results

    Exclusion criteria for the control group
    - T2DM
    - All others as above for the main study
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    - Change in HbA1c at 6 months
    - Change in fasting plasma glucose
    - Change in body weight
    - Percentage of patients reaching ≥5%,10% & 15% weight loss
    - Change in waist circumference
    - Change in appetite and eating habits
    - Change in blood pressure
    - Change in lipids (total cholesterol, LDL, HDL, TAG)
    - Changes in concomitant antidiabetic medications
    - Changes in concomitant antihypertensive medications
    - Changes in concomitant lipid medications
    - Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in adipose tissue
    - Change in the transcriptomics profile of adipose tissue
    - Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in skeletal muscle
    - Change in the transcriptomics profile of skeletal muscle
    - Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver
    - Differences in glucose metabolism, body weight, adiposity-related measures, liver fat, eating habits, blood pressure, lipids, adipose tissue and skeletal muscle metabolism and oxygen uptake and perfusion of tissues between patients with T2DM and healthy controls at baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Change in HbA1c from baseline to 6 months
    - Other secondary endpoints from baseline to 6 and 12 months,
    - Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver from baseline to 12 months
    - Differences in glucose metabolism, body weight, adiposity-related measures, liver fat, eating habits, blood pressure, lipids, adipose tissue and skeletal muscle metabolism and oxygen uptake and perfusion of tissues differ between patients with T2DM and healthy controls at Baseline
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 75
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state75
    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
    Ei poikkea normaalista hoitokäytännöstä
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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