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    Summary
    EudraCT Number:2017-001227-45
    Sponsor's Protocol Code Number:PHT/2017/20
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-001227-45
    A.3Full title of the trial
    Comparison of ambulatory glucose profile prior to and during pancreatic enzyme replacement therapy in patients with diabetes and pancreatic exocrine insufficiency: a single-arm phase IV trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pancreatic replacement therapy and glycaemic control in diabetes
    A.3.2Name or abbreviated title of the trial where available
    Pancreatic replacement therapy and glycaemic control in diabetes v1.0
    A.4.1Sponsor's protocol code numberPHT/2017/20
    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 SponsorPortsmouth Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 supportMylan
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPortsmouth Hospitals NHS Trust
    B.5.2Functional name of contact pointMortlock
    B.5.3 Address:
    B.5.3.1Street AddressR&D Office, Gloucester House
    B.5.3.2Town/ cityQueen Alexandra Hospital
    B.5.3.3Post codePO6 3LY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02392286236
    B.5.6E-mailresearch.office@porthosp.nhs.uk
    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 Creon
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Products Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCreon
    D.3.4Pharmaceutical form Capsule
    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 INNpancreatin PhEur 300 mg
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25,000
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeCreon is extracted from porcine pancreatic tissue
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes and type 2 diabetes mellitus
    Pancreatic exocrine insufficiency
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Pancreatic insufficiency
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033628
    E.1.2Term Pancreatic insufficiency
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare glucose variability in patients with diabetes and pancreatic exocrine insufficiency before starting pancreatic enzyme replacement therapy and 6 weeks after starting pancreatic enzyme replacement therapy.
    E.2.2Secondary objectives of the trial
    To compare other ambulatory glucose profile metrics prior to and 6 weeks after starting pancreatic enzyme replacement therapy:
    - Glucose exposure
    - Mean glucose
    - Time in hyperglycaemia
    - Time in target range
    - Time in hypoglycaemia
    - Glucose instability
    - Estimated HbA1c
    - To compare these during specific time periods including post-prandial (2-3 hours after meal)

    To compare clinically important measures - HbA1c, weight and Body Mass Index
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The participant must meet ALL of the following criteria to be considered eligible for the study:
    1. Male or Female, aged 18 years or above
    2. Diagnosed with Type 1 diabetes or Type 2 diabetes at least 1 year ago and receiving oral and / or insulin therapy for diabetes
    3. Have 1 or more symptoms of PEI:
    - Diarrhoea – Bristol Stool Chart (see appendix) type 5, 6 or 7
    - Steatorrhoea or greasy, pale or offensive smelling stools
    - Weight loss
    - Abdominal pain or cramps
    - Bloating or increased flatulence
    4. Low faecal elastase level <200mcg/g in last 2 years or since diabetes diagnosis, whichever is more recent
    5. Willing and able to give informed consent for participation in the study and for GP to be informed
    E.4Principal exclusion criteria
    The participant may not enter the study if ANY of the following apply:
    1. Currently receiving, or have ever received, PERT
    2. Current prescription of or planning to commence medication (within next 2 months), other than those for diabetes, that may increase or decrease serum glucose levels such as:
    - Oral corticosteroids for more than 7 days
    - Antipsychotics
    - Nutritional supplements such as Fresubin®
    - Weight-loss medication such as orlistat
    3. Diagnosed with or suspected diagnosis of:
    - Pancreatic malignancy
    - Acute pancreatitis or chronic pancreatitis
    - Type 3c diabetes or other secondary Type 3 diabetes
    - Cystic fibrosis
    - Previous or awaited gastric bypass (within next 2 months), pancreatic or extensive small bowel surgery
    - Other primary pancreatic disorder or uncontrolled liver disorder (exception: non-alcoholic fatty liver disease)
    4. Current or recently resolved (within 2 weeks) acute diarrhoeal episode thought likely to be infectious or other gastroenteritis
    5. Current of previous chronic alcohol excess
    6. Currently pregnant, recently postpartum (within 6 months) or planning pregnancy before end of study date
    7. Currently using a modified diet under dietetic supervision, such as FODMAP
    8. Currently receiving supported nutrition, including via nasogastric tube, gastrostomy tube or parenteral nutrition
    9. Known allergy to Creon® or any of its components
    10. Objection to porcine origin of pancreatin
    11. Known allergy to Freestyle Libre Pro adhesive pad
    12. Already enrolled in, or recently (within 6 weeks) taken part in, another study
    - that may affect glycaemic control
    - that may affect digestion or absorption or another aspect of the GI system
    E.5 End points
    E.5.1Primary end point(s)
    Mean interquartile range over 14 days at weeks 6-8 of pancreatic enzyme replacement rherapy as measured by the Freestyle Libre flash glucose monitor
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 10, final study visit
    E.5.2Secondary end point(s)
    Other AGP metrics averaged over 14 days at weeks 6-8 of PERT therapy as measured by the Freestyle Libre flash glucose monitor:
    - Area under the median curve (AUC)
    - Median
    - Time above target range (above 10mmol/L and above 15mmol/L)
    - Time in target range (TIR) (4-10mmol/L)
    - Time below target range (below 4mmol/L and below 3mmol/L)
    - Median curve instability
    - Specific time periods – including pre-prandial and post-prandial
    - Estimated HbA1c

    GI symptom questionnaire at 8 weeks after starting PERT
    Clinical measurements – HbA1c, weight, BMI at 8 weeks after starting PERT
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 10, final study visit
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.4.1Number 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state18
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 18
    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)
    PERT will continue to be available for all participants in the study, as is recommended standard care for treatment of PEI as it is licenced for use and is included in the appropriate local formularies.
    There is a possibility that participants will not achieve adequate response to PERT, in terms of improvement or resolution of symptoms.
    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 Decision2017-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-31
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