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    Summary
    EudraCT Number:2017-000349-30
    Sponsor's Protocol Code Number:NL60669
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000349-30
    A.3Full title of the trial
    Effect of INtervention with DMR, GLP-1 and lifestyle intensification -in Subjects with insulin dePendent type 2 diabetes- on Insulin Requirement and mEtabolic parameters
    Effect van interventie met DMR, GLP-1 en lifestyle intensivering -bij patiënten met insulineafhankelijke type 2 diabetes- op insulinebehoefte en metabole parameters
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of INtervention with DMR, GLP-1 and lifestyle intensification -in Subjects with insulin dePendent type 2 diabetes- on Insulin Requirement and mEtabolic parameters
    Effect van interventie met DMR, GLP-1 en lifestyle intensivering -bij patiënten met insulineafhankelijke type 2 diabetes- op insulinebehoefte en metabole parameters
    A.3.2Name or abbreviated title of the trial where available
    INSPIRE study
    INPIRE studie
    A.4.1Sponsor's protocol code numberNL60669
    A.5.4Other Identifiers
    Name:ABR nummerNumber:NL60669
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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 supportFractyl Laboraties Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointAnnieke van Baar
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205661613
    B.5.5Fax number+31205669156
    B.5.6E-maila.c.vanbaar@amc.nl
    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 Victoza (Liraglutide)
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameVictoza
    D.3.2Product code EMA/354054/2016
    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 IMPIntradermal 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes mellitus
    Diabetes mellitus type 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Suikerziekte type 2
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    The main objective of this pilot study is to evaluate the efficacy of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulindependent type 2 diabetes. Study success is defined as insulin independence at 6 months after DMR with an HbA1c level of ≤ 7.5%.
    E.2.2Secondary objectives of the trial
    The second objective of this pilot study is to identify cardiovascular, metabolic and hepatic health benefits accompanied by this changed treatment strategy. The results of this pilot study will be used to estimate an effect size of this combined treatment in previously insulin dependent subjects. This effect size will be used for an adequate sample size calculation for a subsequent randomized controlled trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 28 -75 years of age
    2. Treatment with long acting insulin ≤ 2 years
    3. On daily long acting insulin dose ≤ 1 U/kg
    4. BMI ≥ 24 and ≤ 40 kg/m2
    5. HbA1c ≤ 8.0% (64 mmol/mol)
    6. Fasting C-peptide ≥ 500 pmol/L (1.5 ng/ml)
    7. Willing to comply with study requirements and able to understand and comply with informed consent
    8. Willing to sign an informed consent form
    E.4Principal exclusion criteria
    1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
    2. Fasting C-peptide < 500 pmol/L (1.5 ng/ml)
    3. Current use of multiple daily doses insulin or insulin pump
    4. Current use of a sulfonylurea derivate or meglitinide
    5. Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
    6. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
    7. History of chronic or acute pancreatitis
    8. Known active hepatitis or active liver disease
    9. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn’s Disease and Celiac Disease
    10. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
    11. Use of anticoagulation therapy (such as phenprocoumon and acenocoumarol) and novel oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot be discontinued for 7 days before and 14 days after the procedure
    12. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
    13. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
    14. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
    15. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
    16. Persistent Anemia, defined as Hgb<10 g/dl
    17. eGFR or MDRD <30 ml/min/1.73m^2
    18. Active systemic infection
    19. Active malignancy within the last 5 years
    20. Not potential candidates for surgery or general anesthesia
    21. Active illicit substance abuse or alcoholism
    22. Participating in another ongoing clinical trial of an investigational drug or device
    23. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
    E.5 End points
    E.5.1Primary end point(s)
    Protocol driven free of insulin at 6 months including and an HbA1c ≤ 7.5%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months follow-up
    E.5.2Secondary end point(s)
    a. HbA1c
    b. Change in HbA1c
    c. Achieving target HbA1c of 7%
    d. FPG
    e. Change in FPG
    f. Peak and AUC glucose in MMTT
    g. Gut hormones in MMTT
    h. Pancreatic hormones in MMTT
    i. Metabolic profile from MMTT
    j. HOMA IR
    k. Insulin sensitivity
    l. Beta cell function
    m. MRFF
    n. ALT and AST
    o. Change in AST and ALT
    p. Fibrosis-4 (FIB-4) score
    q. Change in FIB-4 score
    r. Urine microalbumin
    s. Blood pressure
    t. DEXA body scan
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 3 (if applicable) and 6 months follow-up
    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 Yes
    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) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 16
    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 No
    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 state16
    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)
    Normal care for type 2 diabetes by subjets' own general practicioner.
    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 Decision2017-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-02
    P. End of Trial
    P.End of Trial StatusOngoing
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