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    Summary
    EudraCT Number:2020-005241-16
    Sponsor's Protocol Code Number:CKN-DASI120-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:2021-02-05
    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 number2020-005241-16
    A.3Full title of the trial
    Ready-to-use dasiglucagon for the treatment of postprandial hypoglycaemia in Roux-en-Y gastric bypass operated patients
    RTU-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
    Treatment with a hormone that increases blood sugar levels of individuals that suffers from meal-induced low blow sugar due to bariatric surgery.
    Behandling med et hormon, der øger blodsukkeret hos personer, der lider af måltidsinduceret lavt sukker på grund af bariatrisk kirurgi.
    A.4.1Sponsor's protocol code numberCKN-DASI120-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 Gentofte Hospital
    B.5.2Functional name of contact pointHerlev-Gentofte Hospital
    B.5.3 Address:
    B.5.3.1Street AddressGentofte Hospitalsvej 7, hall 7, 3rd floor
    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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.9.1CAS number 1544300-84-6
    D.3.9.4EV Substance CodeSUB193123
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    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 in dose-dispenser cartridge
    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
    Long-term treatment of 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
    The primary aim of the study is to compare the effects of self-administered 120 µg dasiglucagon versus placebo (during postprandial hypoglycaemia) on CGM-assessed time spent in hypoglycaemia in RYGB-operated individuals in an out-patient setting.
    Studiets primære formål, er at sammenligne virkningerne af selvadministreret 120 µg dasiglucagon versus placebo (under postprandial hypoglykæmi) på CGM-vurderet tid tilbragt i hypoglykæmi hos fritlevende RYGB-opererede individer.
    E.2.2Secondary objectives of the trial
    Secondary aims are to evaluate the effects of self-administered 120 µg dasiglucagon versus placebo on CGM-assessed incidences of serious hypoglycaemia (<3.0 mmol/l), blood glucose (BG) recovery, symptomatic recovery, glucose peak and nadir concentrations and glycaemic variability compared to placebo treatment. Moreover, we aim to examine the effects of dasiglucagon treatment on hypoglycaemic symptoms, fear of hypoglycaemia and quality of life (QoL) using standardised questionnaires.
    Sekundære mål, er at evaluere virkningerne af selvadministreret 120 µg dasiglucagon versus placebo på CGM-vurderede forekomster af alvorlig hypoglykæmi (<3,0 mmol / l), blodglukose (BG) genopretning, symptomatisk opsving, glukose peak og nadir koncentrationer og glykæmisk variation sammenlignet med placebobehandling. Desuden tilstræber vi at undersøge virkningerne af behandling med dasiglucagon på hypoglykæmiske symptomer, frygt for hypoglykæmi og livskvalitet (QoL) ved hjælp af standardiserede spørgeskemaer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Documented postprandial hypoglycaemia (IG <3.9 mmol/l, ≥3 times/week) assessed by 14-days of blinded CGM recording
    - 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, glucose metabolism or any antidiabetic drugs
    - Treatment with antipsychotics
    - Current participation in another clinical trial with administration of investigational drug
    - Previous exposure to dasiglucagon (also known as ZP4207) within the last 30 days prior screening
    - History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis)
    - Pregnancy
    - Breastfeeding
    - Major surgery within 30 days before screening
    - Alcohol abuse (per investigator assessment)
    - 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
    - History of pheochromocytoma or insulinoma
    - History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
    - Known or suspected allergies to glucagon or related products
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of time in hypoglycaemia (IG <3.9 mmol/l) assessed by CGM during the out-patient part.
    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 during out-patient part:
    • Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l))
    • Change in QoL as assed by EORTC-QLQ-PAN26
    • Change in hypoglycaemic symptoms will be evaluated after dosing by Edinburgh Hypoglycaemia Symptom Scale (EHSS)
    • Change in fear of hypoglycaemia as assessed by Hypoglycaemia Fear Scale
    • Change in administration frequency (as measured by percentage)

    All the following in-patient part endpoints refers to the difference between placebo- and treatment arm (dasiglucagon 120 µg).
    Secondary endpoints from the in-patient part of the study are:

    • The key secondary endpoint of the in-patient part is the mean nadir plasma glucose compromised three concurrently glucose measurements during the 240-minute MMT
    • Recovery of BG 15 minutes after administration (as measured by finger prick (BG >3.9 mmol/l))
    • Time spent in level 1 and level 2 hypoglycaemia (<3.9 and <3.0 mmol/l, respectively) from study drug administration until 240 minutes
    • Glycaemic rescue intervention due to critically low plasma glucose concentration (<1.8 mmol/l)
    • Time spent in hyperglycaemia (>7.8 mmol/l, respectively) from study drug administration until 240 minutes
    • Peak plasma glucose concentration after study drug administration
    • Changes in plasma / serum concentrations of insulin, C-peptide, glucagon, glucagon-like peptide 1, glucagon-like peptide 2, glucose-dependent insulinotropic polypeptide, epinephrine, norepinephrine, growth hormone and cortisol measured as area under the curve (AUC) and / or incremental (iAUC) as appropriate, peak values and values at nadir plasma glucose concentration
    • Changes in heart rate and blood pressure

    Safety endpoints include:
    • Frequency and severity of adverse events (AE)s and serious adverse events (SAE)s during the in-patient part MMTs and the out-patient part
    • Percentage (%) of subjects with treatment-induced or treatment-boosted anti-dasiglucagon antibodies

    Device endpoint:
    • Device failures/ malfunctions occurring during the trial.
    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 Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Medical device safety
    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 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.8.4.1Number 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
    Q2 2021 - Q2 2022
    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 months4
    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: 24
    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 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 state24
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 24
    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 Steno Diabetes Center Copenhagen
    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 Decision2021-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-12
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