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    Summary
    EudraCT Number:2019-004586-41
    Sponsor's Protocol Code Number:UOL0753
    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:2020-08-13
    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 number2019-004586-41
    A.3Full title of the trial
    Impact of exercise training in combination with dapagliflozin on physical function in adults with type 2 diabetes mellitus: A Randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dapagliflozin, Exercise Training and physicAl function: the DETA trial.
    A.3.2Name or abbreviated title of the trial where available
    Dapagliflozin, Exercise Training and physicAl function; the DETA trial
    A.4.1Sponsor's protocol code numberUOL0753
    A.5.4Other Identifiers
    Name:EudraCT referenceNumber:2019-004586-41
    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 supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leicester
    B.5.2Functional name of contact pointProfessor Melanie Davies
    B.5.3 Address:
    B.5.3.1Street AddressLeicester Diabetes Centre, Leicester General Hospital
    B.5.3.2Town/ cityGwendolen Road, Leicester
    B.5.3.3Post codeLE5 4PW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01162586481
    B.5.6E-mailmelanie.davies@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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.2Product code Not applicable
    D.3.4Pharmaceutical form 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 INNDapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.3Other descriptive nameForxiga
    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
    Frailty and the preceding 'pre-frail' state in patients with type 2 Diabetes Mellitus.
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes Mellitus
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to investigate the effects of exercise training in individuals prescribed dapagliflozin for the management of type 2 diabetes on physical function, compared to diet-induced weight loss or dapagliflozin alone.
    E.2.2Secondary objectives of the trial
    Major secondary objectives are to examine the effects of dapagliflozin-plus-exercise or dapagliflozin alone on markers of cardiac function, factors underpinning physical function and other markers of cardiometabolic health.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The two optional sub-studies are as follows:

    (i) Skeletal muscle biopsy sub-study: 10 participants in each of the DAPA+EX, DAPA and DIET-CON groups will undergo a further two optional visits, one during Baseline Assessments (Visit 1x) and one during Week 24 Assessments (Visit 3x). Each of these visits will contain a skeletal muscle biopsy and an additional blood test. Muscle biopsies will be analysed for key signalling proteins related to a number of biochmecial pathways in the body.

    (ii) MRI sub-study: 20 individuals in the DAPA group only will also undergo an additional optional MRI assessment (Visit 2x). MRI imaging will used to measure cardiac outcomes only.
    E.3Principal inclusion criteria
    (i) Men and women
    (ii) Age 40 to 75 years, inclusive
    (iii) Diagnosed T2DM, treated by lifestyle management alone or in combination with mono- or combination therapy with oral glucose-lowering pharmacological therapies (with exception of pre-defined exclusion criteria; see below)
    (iv) HbA1c 6.5 to 10% (47 to 86 mmol/mol), inclusive
    (v) Historical evidence of functional limitation or frailty defined as at least one of :
    a. Impaired physical function or frailty; SPPB score 1 to 10 (inclusive) recorded within the preceding 5 years
    b. A coding of mild-to-moderate frailty based on the Electronic Frailty Index (eFI) within primary care
    c. V02peak ≤ 18 ml/kg recorded within the preceding 5 years
    d. SARC-F questionnaire score of 4 or more
    (vi) BMI ≥ 25 kg/m2 (≥ 22.5 kg/m2 if of Ssouth Asian ethnicity)
    (vii) Weight stable; < 3kg weight change in preceding 3 months
    (viii) Treatment stable; no significant change to glucose-lowering regimen in the preceding 3 months, as determined by a study investigator
    (ix) Able and willing to give informed consent
    (x) Able to understand spoken English
    (xi) Able to take part in structured exercise training (in the opinion of the Investigator).
    E.4Principal exclusion criteria
    (i) Individuals with type 1, gestational or monogenic diabetes mellitus
    (ii) eGFR < 60 ml.min-1 per 1.73m2 or as per licencing at the point of prescription
    (iii) Individuals with familial renal glycosuria
    (iv) Documented or self-reported cirrhosis
    (v) Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
    (vi) Individual with recurrent balanitis, vaginal or urinary tract infections
    (vii) Current or planned pregnancy, or breast feeding
    (viii) Females of childbearing age, unwilling to use adequate contraceptive methods during the study period
    (ix) Currently on SLGT2i, GLP-1RA, basal-bolus or premixed insulin therapies
    (x) Contra-indications to exercise or SGLT2i therapy
    (xi) Current participation in another research study with investigational medical product
    (xii) Scoring 0 on the SPPB, or otherwise unable to complete the test due to severe functional limitations
    (xiii) Active malignancy; at discretion of study clinician
    (xiv) Serious illness with life-expectancy < 1 year or other significant illness which, in the opinion of a study clinician, precludes involvement
    (xv) Individuals with history of chronic pancreatitis
    (xvi) Individuals with Latent Autoimmune Diabetes in Adults (LADA)
    (xvii) Patients with a history of excessive alcohol consumption
    (xviii) Patients on a severely calorie restricted diet (i.e. <800 calories per day)


    Additional exclusion criteria for MRI scanning visits (this does not impact on the participant’s enrolment in the study)
    (i) Individuals with absolute contra-indication to MRI that, in the opinion of a study clinician, precludes an MRI scan will not be invited to attend the MRI visits, but will engage in all other aspects of the study.

    Additional exclusion criteria for individuals wishing to undertake skeletal muscle biopsy sub-study (this does not impact on the participant’s enrolment in the main study)
    (i) Individuals taking any medication that, in the opinion of a study clinician, preclude involvement in the muscle biopsy sub-study (including blood thinning medications).
    (ii) Individuals with any concurrent disease/condition that, in the opinion of a study clinician, precludes involvement in the muscle biopsy sub-study (including those with low platelet counts and those with blood borne infections).
    (iii) Individuals with a documented or self-reported history of local anaesthetic sensitivity.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in the change in physical function between groups (measured using the modified physical performance test; mPPT) at 24 weeks. All other comparisons and outcomes will be considered secondary.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The change in physical function between groups will be measured at 24 weeks.
    E.5.2Secondary end point(s)
    Difference between groups at 24 weeks in relative aerobic capacity, lean body mass and circumferential peak early-diastolic strain rate (all powered), other indices of physical activity/fitness and body composition, other indices of cardiac structure and function, HbA1c, cardiovascular risk factors, systemic inflammation, skeletal muscle metabolic signalling pathways (protein balance, insulin signalling, inflammatory), mental wellbeing and quality of life (all exploratory).


    E.5.2.1Timepoint(s) of evaluation of this end point
    The difference between groups will be measured at 24 weeks, as per the primary end point. The time-course of change will also be assessed at 12 weeks.
    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.6.13.1Other scope of the trial description
    new outcome
    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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Exercise (in combination with IMP) and diet (control)
    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.8.5The 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
    The end of trial is the date of the final statistical analysis for primary or secondary outcomes.
    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 months6
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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)
    In the UK dapagliflozin is licensed for use in T2D but is more likely to be initiated after metformin and gliclazide (NICE guidelines). If their GP agrees, participants should be able to continue dapagliflozin after study completion (whether on metformin or not). Participants who were not randomised to dapagliflozin may also discuss the use of this treatment with their GP after completing the study. This information will be specified on the participant information sheet.
    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 Decision2020-04-28
    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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