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    Summary
    EudraCT Number:2018-004120-11
    Sponsor's Protocol Code Number:GN17DI706
    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:2020-03-16
    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 number2018-004120-11
    A.3Full title of the trial
    Triple Therapy for Type 1 Diabetes with Insulin, Semaglutide and Dapagliflozin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Triple Therapy for Type 1 Diabetes with Insulin, Semaglutide and Dapagliflozin.
    A.3.2Name or abbreviated title of the trial where available
    TTT1 study
    A.4.1Sponsor's protocol code numberGN17DI706
    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 SponsorNHS Greater Glasgow and Clyde
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNHS Greater Glasgow and Clyde
    B.5.2Functional name of contact pointDr Maureen Travers
    B.5.3 Address:
    B.5.3.1Street AddressLevel 1, Ward 11, Dykebar Hospital
    B.5.3.2Town/ cityRenfrewshire
    B.5.3.3Post codePA2 7DE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01413144012
    B.5.6E-mailMaureen.Travers@ggc.scot.nhs.uk
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Glasgow
    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 supportJDRF
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Ozempic
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOzempic
    D.3.2Product code Not applicable
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSemaglutide
    D.3.9.1CAS number 910463-68-2
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.34
    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.IMP: 2
    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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameForxiga
    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 INNDapagliflozin propanediol monohydrate
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameDapagliflozin
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether the addition of a drug designed to increase the amount of sugar removed from the body (dapagliflozin) and semaglutide to insulin (triple therapy) improves blood glucose control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment.
    E.2.2Secondary objectives of the trial
    To assess whether
    1: Semaglutide in addition to insulin treatment over 26 and 52 weeks will significantly improve HbA1c levels compared with insulin therapy alone.

    2: Combined dapagliflozin and semaglutide treatment in addition to insulin will significantly improve glucose control and the percent of time spent in normal zone range (80-160mg/dl) with lower insulin requirements compared with semaglutide and insulin (dual therapy) or insulin only (standard) treatment treatment alone.

    3: combined dapagliflozin and semaglutide treatment will improve postprandial glucose excursions and suppress postprandial glucagon compared with semaglutide and insulin or insulin therapy alone.

    4: Combined dapagliflozin and semaglutide in addition to insulin therapy will reduce blood pressure compared with semaglutide and insulin (dual therapy) or insulin only (standard) treatment.

    5: Combined dapagliflozin and semaglutide in addition to insulin therapy (triple therapy) will result in weight loss co
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Type 1 Diabetes for at least 1 year on stable multiple daily (four or more) injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII) for the previous three months.
    2) C-peptide < 0.23 nM
    3) Minimum dose of insulin: 0.5 U/kg for MDI and 0.4 U/kg for CSII
    4) Regularly measuring blood glucose four or more times daily by fingerprick, (or by "flash" or continuous glucose monitoring).
    5) HbA1c >7.5%
    6) Well versed in Carbohydrate (CHO) counting*
    7) Age 18-70 years.
    8) BMI ≥25 kg/m2.

    *In the opinion of the site Principal Investigator
    E.4Principal exclusion criteria
    1) Type 1 diabetes for < 12 months, type 2 diabetes, chronic pancreatitis, MODY
    2) Previous use of any agent other than insulin for glycaemic control in the last three months.
    3) History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalisation) within three months prior to the screening visit.
    4) Following ketogenic diet, low (<50g/day) carbohydrate diet or intermittent fasting.
    5) Hypoglycaemia unawareness* or frequent episodes of severe hypoglycaemia as defined by more than one episode requiring medical assistance, emergency care (paramedics or emergency room care), or glucagon therapy administered by a third-party individual within three months prior to the screening visit
    6) Symptoms of poorly controlled diabetes
    7) Participation in a weight loss program with ongoing weight loss, or in an intensive exercise program
    8) History of bariatric or other weight-loss surgery within 12 months prior to the screening visit
    9) History of Addison’s disease or chronic adrenal insufficiency
    10) History of diabetes insipidus
    11) Hepatic disease or cirrhosis
    12) Aspartate Aminotransferase (AST) > 3 X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) > 3 X ULN
    13) Serum Total Bilirubin > 2 X ULN unless exclusively caused by Gilbert’s Syndrome
    14) Haemoglobin < 110 g/L (11.0 g/dL) for men; haemoglobin < 100 g/L (10.0 g/dL) for women
    15) Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous three months or history of congestive heart failure
    16) End stage renal disease on haemodialysis and/or eGFR < 60 ml/min/1.73m2
    17) HIV or Hepatitis B/C positive status
    18) Any other life-threatening, non-cardiac disease
    19) History of pancreatitis or cystic fibrosis
    20) Women who are pregnant, planning pregnancy or breast-feeding and women of childbearing potential (WOCBP) who are not established on a method of adequate contraception considered highly effective (see Appendix 2) and willing to continue it for the duration of the study and for at least two months after last dose of IMP.
    21) Inability to give informed consent
    22) History of gastroparesis
    23) History of medullary thyroid carcinoma or MEN 2 syndrome
    24) History of hypersensitivity reaction to GLP-1 agonists or SGLT2 inhibitors or known hypersensitivity to any of the excipients
    25) Known gallstones (history of cholecystectomy is not an exclusion criterion)
    26) History of alcohol problem or drug abuse
    27) Hypertriglyceridemia (>500 mg/dl)
    28) Recurrent genital mycotic infection (more than one episode in last six months)
    29) Hypovolaemia
    30) Any malignancy except treated in situ malignancy and basal cell carcinoma of the ski
    31) Unexplained haematuria (dipstick positive on two occasions one week apart) and/or active bladder cancer
    32) Proliferative retinopathy (on basis of photographic retinal screening which must have been performed within the last 12 months
    33) Use of an investigational agent or therapeutic regimen within 90 days of study
    34) Participation in any other concurrent interventional clinical trial
    35) Unlikely to be able to comply with study requirements*
    * In the opinion of the site Principal Investigator
    E.5 End points
    E.5.1Primary end point(s)
    The Primary Outcome measure of this study is to assess in people with type 1 diabetes whether triple therapy (dapagliflozin, semaglutide and insulin) reduces HbA1c in comparison with dual therapy (placebo, semaglutide, and insulin).
    E.5.2Secondary end point(s)
    Efficacy:
    Change in HbA1c
    Mean fasting blood glucose
    Mean blood glucose*
    Percentage time in range (3.9 - 10.0 mmol/)*
    Standard deviation of blood glucose*
    Percentage time in hyperglycaemia Level 1 (10.1 - 13.9 mmol/L/)*
    Percentage time in hyperglycaemia Level 2 (>13.9 mmol/L) *
    Percent time in hypoglycaemia Level 1 (3.0 - 3.8 mmol/)*
    (* by masked DEXCOM G6 CGM)
    Insulin requirement
    Bodyweight
    Systolic and diastolic BP
    Number of antihypertensive medications
    Diabetes Specific Quality of Life Scale (DSQOLS)
    Problem Areas In Diabetes (PAID) questionnaire
    Safety:
    Rate of hypoglycemic events Level 2 (<3.0 mmol/L/ <54mg/dl)
    Rate of hypoglycemic events Level 3 (severe event with altered mental and/or physical status requiring assistance)
    Rate of diabetic ketoacidosis defined as elevated serum or urine ketones (greater than the upper limit of the normal range), and serum bicarbonate < 15 mmol/L or blood pH < 7.3
    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) 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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 Information not present in EudraCT
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    Last subject Last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 Yes
    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 state57
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 114
    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)
    At the end of the trial, participants will be returned to usual care as defined by local and national guidelines at that time.
    Treatment with semaglutide and dapagliflozin will not continue beyond the end of the participant’s study involvement.
    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 Decision2020-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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