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    Summary
    EudraCT Number:2019-004041-32
    Sponsor's Protocol Code Number:0701
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-07-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-004041-32
    A.3Full title of the trial
    The effect of Canagliflozin 300mg, in subjects without diabetes after bariatric surgery, on glucose homeostasis (The CONTROL Study): A proof-of-concept, randomised, open-label, two period crossover study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of canagliflozin 300mg on glucose levels in people without diabetes after weight loss surgery.
    A.3.2Name or abbreviated title of the trial where available
    The CONTROL Study
    A.4.1Sponsor's protocol code number0701
    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 SponsorUniversity of Leicester
    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 supportAcademy of Medical Sciences
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeicester Diabetes Centre
    B.5.2Functional name of contact pointDr Dimitris Papamargaritis
    B.5.3 Address:
    B.5.3.1Street AddressGwendolen Road
    B.5.3.2Town/ cityLeicester
    B.5.3.3Post codeLE5 4PW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01162588973
    B.5.6E-maildimitris.papamargaritis@uhl-tr.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 Invokana
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameInvokana
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNCanagliflozin
    D.3.9.1CAS number 842133-18-0
    D.3.9.3Other descriptive nameInvokana
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postprandial hypoglycaemia after bariatric surgery
    E.1.1.1Medical condition in easily understood language
    Low glucose levels after a meal in patients who have undergone weight loss surgery
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    To investigate the effect of canagliflozin on glucose levels, insulin and gut hormones after a meal in patients without diabetes after weight-loss surgery.
    E.2.2Secondary objectives of the trial
    To investigate the effect of canagliflozin on glucose levels and the incidence of low blood glucose levels during daily life (assessed through a continuous glucose monitoring system) in patients without diabetes after weight-loss surgery. Moreover, we will assess the effect of canagliflozin and low blood glucose symptoms after consumption of a meal in patients without diabetes after weight-loss surgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age≥18 years old but less than 75 years old
    • Subjects ≥1 year after gastric bypass (RYGB) or sleeve gastrectomy (SG)
    • Able to understand written and spoken English
    • Able to give informed consent
    E.4Principal exclusion criteria
    • Use of any glucose-lowering medication (including insulin)
    • Adrenal insufficiency and/or substitution with glucocorticoids
    • ALT >1.5 times the upper normal limit
    • Moderate to severe renal impairment (eGFR≤60 ml/min/1.73m2)
    • Individuals on loop diuretics
    • Participants with established diagnosis of postural hypotension by their GP
    • Recent active infection (over the last 10 days)
    • Current use of steroids
    • Other bariatric procedure except of RYGB/SG
    • Previous revisional bariatric surgery
    • Currently pregnant or breastfeeding
    • Females of child-bearing age, unwilling to use contraception during the period of the study
    • Patients with history of Type 1 or Type 2 diabetes
    • Intolerant to the Mixed Meal Tolerance test.
    • HbA1C ≥ 6.5% or ≥48mmol/l at screening blood tests
    • Haemoglobin (Hb) <100 g/L at screening blood tests
    • Clinical contraindication to Canagliflozin
    • Known osteoporosis
    • Previous history of Fournier’s gangrene
    • History of epilepsy
    • Known foot ulcers/previous amputation
    • Participating in another research study involving intervention within 3 months of screening
    • Having a formal previous diagnosis of postprandial hypoglycaemia
    • Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
    • Participants without established previous diagnosis of postprandial hyperinsulinaemic hypoglycaemia but with symptoms suggestive of frequent (defined as more than once weekly) AND severe postprandial hypoglycaemia at the screening hypoglycaemia questionnaire (severe is defined as at least 2 symptom on Edinburgh Hypoglycaemia Scale (EHS) Questionnaire with intensity >5 in a scale from 1 to 7) over the last 2 months.
    E.5 End points
    E.5.1Primary end point(s)
    The difference in nadir (lowest) glucose levels between the two treatment options (canagliflozin 300mg vs no treatment) during the standardised mixed meal test for RYGB and SG (separate analysis for subjects who have undergone RYGB and for subjects who have undergone SG).
    For patients who will develop hypoglycaemia during the MMTT (defined as glucose levels ≤3.0 mmol/l) and the test will be stopped for safety reasons, the glucose levels at the time that the test will be completed will be taken into account as the nadir glucose level.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 days after initiation of canagliflozin 300mg once daily (vs 5 days with "no treatment"). These investigations will take place at day 5 and day 32 of the study.
    E.5.2Secondary end point(s)
    1.Difference in Area Under the Curve (AUC)(0-180), fasting and peak glucose levels after MMTT between the two treatment options (cana 300mg vs no treatment) after RYGB and SG
    2.Difference in AUC(0-180) insulin, fasting and peak insulin levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    3.Difference in AUC(0-180) Glucagon Like Peptide-1 (GLP-1), fasting and peak GLP-1 levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    4.Difference in AUC(0-180) c-peptide, fasting and peak c-peptide levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    5.Difference in AUC(0-180) glucagon, fasting and peak glucagon levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    6.Difference in the ratio AUC(0-180) insulin/AUC(0-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    7.Difference in the ratio AUC(0-30) insulin/AUC(0-30) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    8.Difference in the ratio AUC(60-180) insulin/AUC(60-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    9.Difference in the ratio AUC(0-180) c-peptide/AUC(0-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    10.Difference in the ratio AUC(0-30) c-peptide/AUC(0-30) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    11.Difference in the ratio AUC(60-180) c-peptide/AUC(60-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    12.Difference in the ratio of maximum/minimum plasma glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    13.Difference in AUC(0-180) of Sigstad score and peak Sigstad score after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    14.Difference between AUC(0-180) of Edinburgh Hypoglycaemia Scale score and peak Edinburgh Hypoglycaemia Scale score after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    15.Difference at the number of mixed meal tests required to be stopped due to blood glucose levels or capillary glucose levels ≤3.0mmol/l after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    16.The Amount of glucose (in grams) needed to restore euglycaemia between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    17.Difference in %time in interstitial glucose levels <3.9mmol/l in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    18.Difference in % time in hypoglycaemia (defined as interstitial glucose levels ≤3.0mmol/l) in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    19.Difference in % time in interstitial glucose levels ≤2.2mmol/l in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    20.Difference in % time in range (defined as 3.9 – 7.8mmol/l) in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    21.Difference in % time in interstitial glucose levels between 3.9 – 10mmol/l in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    22.Difference in % time interstitial glucose >7.8mmol/l in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    23.Difference in % time interstitial glucose >10mmol/l in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    24.Difference in the mean interstitial glucose in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    25.Difference in the standard deviation (SD) of the mean interstitial glucose between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    26.Difference in the coefficient of variation (CV) (CV=SD/mean interstitial glucose) between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    27.Difference in mean amplitude glucose excursion (MAGE) in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    28.Difference in the frequency and intensity of symptoms suggestive of postprandial hypoglycaemia reported by the patients during CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG
    29.Difference in the number of hypoglycaemic events/day (defined as interstitial glucose levels ≤3.0mmol/l) in CGM between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG

    Outcomes for 30-32 Please see A58 in IRAS (statistical review) as character amount exceeded.
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 days after initiation of canagliflozin 300mg once daily (vs 5 days with "no treatment"). These investigations will take place at day 5 and day 32 of the study.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment
    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 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
    End of the trial is defined as:
    upon analysis of results
    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 months3
    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 months4
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 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)
    After the study, participants will stop taking canagliflozin (as there is currently no license for use of the medication in patients without diabetes) and will return to standard care. Patients who have been identified with postprandial hypoglycaemia during the study will be provided with nutritional information in the form of a leaflet.
    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 Decision2020-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-01
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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