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    Summary
    EudraCT Number:2019-001915-22
    Sponsor's Protocol Code Number:CKN-DASI-RYGB
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-26
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-001915-22
    A.3Full title of the trial
    Dasiglucagon in the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass
    Behandling med dasiglucagon ved postprandial hypoglykæmi efter Roux-en-Y gastrisk bypass
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hormone treatment of low blood sugar due to meal ingestion in individuals with a reduced stomach size
    Hormonbehandling af lavt blodsukker ved indtagelse af måltid hos individer med reduceret mavesækstørrelse
    A.4.1Sponsor's protocol code numberCKN-DASI-RYGB
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03984370
    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 SponsorCenter for Clinical Metabolic Research at Herlev-Gentofte Hospital
    B.1.3.4CountryDenmark
    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 supportZealand Pharma
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Clinical Metabolic Research at Herlev-Gentofte Hospital
    B.5.2Functional name of contact point Herlev-Gentofte Hospital
    B.5.3 Address:
    B.5.3.1Street AddressKildegårdsvej 28, Gentofte hospital, opgang 7 3. sal, CMP
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4560117434
    B.5.6E-mailcasper.kjaersgaard.nielsen@regionh.dk
    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 nameDasiglucagon (4 mg/mL)
    D.3.2Product code ZP4207
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDASIGLUCAGON
    D.3.9.2Current sponsor codeCKN-DASI-RYGB
    D.3.9.3Other descriptive nameZP4207
    D.3.9.4EV Substance CodeSUB193123
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80 to 200
    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 placeboSolution for injection/infusion
    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
    Postprandial hyperinsulinemic hypoglycaemia
    E.1.1.1Medical condition in easily understood language
    Low blood sugar due to meal ingestion in postoperative Roux-En-Y individuals.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10079748
    E.1.2Term Reactive hypoglycaemia
    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
    This is a proof-of-concept study aiming to evaluate the use of dasiglucagon in the management of postprandial hyperinsulinaemic hypoglycaemia in RYGB-operated individuals. To examine the effects of two different doses of dasiglucagon on the postprandial nadir plasma glucose concentration in RYGB-operated individuals suffering from postprandial hyperinsulinaemic hypoglycaemia by use of a mixed meal test (MMT).
    E.2.2Secondary objectives of the trial
    Secondary aims: To further asses the effects of two different doses of dasiglucagon on measurements of hypoglycaemia and postprandial glucose levels, as well as the postprandial changes in glucose-regulatory hormone levels (insulin, C-peptide, cortisol, growth hormone, GLP-1, GLP-2, glucagon, GIP, epinephrine and norepinephrine). Moreover, the study aims to examine the effects of dasiglucagon on hypoglycaemic symptoms and symptoms of early dumping in the postprandial period, and to investigate markers of early dumping (heart rate, haematocrit, and norepinephrine) in order to separate physiological changes caused by early dumping and postprandial hypoglycaemia. Finally, the study intents to evaluate the frequency of hypoglycaemic events, time spent in hypoglycaemia and glycaemic variability during normal daily living without dasiglucagon intervention by means of continued glucose monitoring (CGM).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Documented postprandial hypoglycaemia (<3.9 mmol/l) by 6-day CGM or during a MMT
    - Documented plasma glucose concentration excursions >5.0 mmol/l by 6-day CGM or a MMT
    - Haemoglobin levels for women >7.3 mmol/l and for men >8.3 mmol/l
    - Ferritin >10 μg/l
    - Cobalamin >150 pmol/l
    - Fasting plasma glucose concentration within the range of 4.0–6.0 mmol/l
    - Normal electrocardiogram (ECG)
    - Negative urine human chorionic gonadotropin (hCG) (for fertile women)
    E.4Principal exclusion criteria
    - Treatment with medication(s) affecting insulin secretion or any antidiabetic drugs
    - Treatment with antipsychotics
    - Current participation in another clinical trial with administration of investigational drug.
    - Previous exposure to dasiglucagon (otherwise known as ZP4207)
    - History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis).
    - Pregnancy
    - Breastfeeding
    - Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial or allergy to the ingredients in the study drug.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    • Nadir plasma glucose concentration within 240 minutes after MMT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all patients have completed the study and samples are analysed.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level)
    • Time in hypoglycaemia (plasma glucose concentration <3.9 mmol/l) from study drug administration until 240 minutes
    • Time below fasting plasma glucose level from study drug administration until 240 minutes
    • Area 1: the area above the glucose curve and below the fasting level from the time of study drug administration until glucose values reach the fasting level.
    • Area 2: the area below the glucose curve and above the fasting level from the time glucose values reach the fasting level until 240 minutes.
    • Severity score of postprandial neuroglycopenic signs and symptoms calculated from patients' responses of the Edinburgh Hypoglycaemia Symptom Scale (EHSS) and early dumping symptoms based on the Dumping Severity Score (DSS).
    Safety endpoints:
    • Frequency and severity of adverse events and serious adverse events
    Other endpoints:
    • Glycaemic rescue interventions within 240 minutes of the MMT
    • Peak plasma glucose concentration after dasiglucagon or placebo injection
    • Changes in plasma/serum concentrations of: insulin, C-peptide, glucagon, GLP-1, GLP-2, glucose-dependent insulinotropic polypeptide (GIP), epinephrine, norepinephrine, growth hormone and cortisol measured as bsAUC, peak values and values at nadir plasma glucose concentration.
    • Changes in heart rate and blood pressure
    • Changes in haematocrit within the first 60 minutes of the MMT
    • Frequency of hypoglycaemic events (interstitial fluid glucose (IG) <3.9 mmol/l and <3.0 mmol/l), time spent in hypoglycaemia (IG <3.9 mmol/l and <3.0 mmol/l), minimum IG measurement, mean IG measurement, maximum IG measurement, frequency of hyperglycaemia (IG >7.8 mmol/l and >10.0 mmol/l), time spent in hyperglycaemia (IG >7.8 mmol/l and >10.0 mmol/l), and measurements of glycaemic variability (standard deviation, coefficient of variance) and risk of hyper- and hypoglycaemia (HBGI and LBGI) during the CGM periods.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After all patients have completed the study and samples are analysed.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Crossover study design with 6 possible treatment sequences. 3-treatmet, 3-period crossover trial
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    Q4 2019 - Q1 2020
    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: 10
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 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 state10
    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)
    Carbohydrate restricted dieting
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medicinsk Afdeling, Køge Sygehus
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-26
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