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    Summary
    EudraCT Number:2015-002095-24
    Sponsor's Protocol Code Number:H9X-MC-GBGE(b)
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-01
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-002095-24
    A.3Full title of the trial
    Protocol H9X-MC-GBGE(b)
    A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus (AWARD-10: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 10)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Protocol H9X-MC-GBGE(b)
    A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus (AWARD-10: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 10)
    A.3.2Name or abbreviated title of the trial where available
    H9X-MC-GBGE(b) AWARD-10
    A.4.1Sponsor's protocol code numberH9X-MC-GBGE(b)
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    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 Trulicity
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameDULAGLUTIDE
    D.3.9.4EV Substance CodeSUB130484
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameDULAGLUTIDE
    D.3.9.4EV Substance CodeSUB130484
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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.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 pre-filled pen
    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
    Type 2 Diabetes
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term 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 demonstrate that once-weekly dulaglutide (1.5 mg and/or 0.75 mg) is superior to placebo as measured by HbA1c at 24 weeks (change from baseline) in patients
    with inadequately controlled T2D on concomitant SGLT2 inhibitor therapy.
    E.2.2Secondary objectives of the trial
    Key secondary efficacy objectives (controlled for type 1 error) are to compare dulaglutide 1.5 mg and 0.75 mg to placebo at 24 weeks

    Other secondary efficacy objectives are to compare
    dulaglutide 1.5 mg and 0.75 mg to placebo at 24 weeks

    Secondary safety objectives are to compare dulaglutide
    1.5 mg and 0.75 mg to placebo at 24 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] are men or non-pregnant women aged ≥18 years at screening
    [2] have T2D
    [3] have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry
    [4] daily doses of all allowed OAMs must have been stable for at least 12 weeks (± 3 days) prior to randomization
    [5] have HbA1c ≥7.0% and ≤9.5% at study entry
    [6] have body mass index (BMI) ≤45 kg/m2 and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight;
    [7] are able and willing to administer once-weekly injections;
    [8] in the investigator’s opinion, are well motivated, capable, and willing to:
    a) perform finger-stick plasma glucose monitoring including scheduled daily PG profile with up to 6 measurements in 1 day;
    b) learn how to self-inject treatment, as required for this protocol
    c) maintain a study diary, as required for this protocol;
    [9] Women of childbearing potential participating must agree to remain abstinent, use 1 highly effective method of contraception (eg, combined oral contraceptive pill and mini-pill, NuvaRing, implantable contraceptives, injectable contraceptives, intrauterine devices or use a combination of 2 effective methods (eg, male condom with spermicide, female condom with spermicide, diaphragm with spermicide, cervical sponge, cervical cap with spermicide) for the entirety of the study. Abstinence or contraception must continue following completion of study drug administration until 4 weeks after the last dose of study drug.
    [10] have given written and informed consent to participate in this study in accordance with local regulations and the Ethical Review board (ERB) governing the study site.
    E.4Principal exclusion criteria
    [11] have type 1 diabetes mellitus;
    [12] have been treated with ANY other OAMs (other than SGLT2s and metformin), GLP-1 receptor agonist or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary;
    [13] have any condition that is a contraindication for use of the GLP-1 analog class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization
    [14] for patients using metformin, if a condition that is a contraindication for its use develops between stabilization and randomization;
    [15] discontinue therapy with SGLT2 inhibitors any time prior to randomization and/or metformin, if used, between stabilization and randomization based on the Exclusion Criteria described under [13] and [14] above, or any other reason;
    [16] have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma prior to study entry;
    [17] have a history of hypoglycemia unawareness within the 6 months prior to study entry;
    [18] have been treated with drugs that promote weight loss or have received a diet and/or exercise program with the intent of reducing body weight within 3 months prior to study entry or between study entry and randomization
    [19] are receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) any time between entry and randomization or have received such therapy within 4 weeks prior to study entry;
    [20] have had any of the following cardiovascular (CV) conditions within 2 months prior to study entry: acute myocardial infarction, New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke);
    [21] have a known clinically significant gastric emptying abnormality at study entry, or have undergone bariatric surgery in the past;
    [22] have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; patients with NAFLD are eligible for participation in this trial;
    [23] had chronic or acute pancreatitis any time prior to study entry;
    [24] have an estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead in;
    [25] have evidence of a significant, uncontrolled endocrine abnormality at study entry, in the opinion of the investigator;
    [26] have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia
    [27] have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome);
    [28] have a serum calcitonin ≥20 pg/mL as determined by the central laboratory at study entry;
    [29] have evidence of a significant, active autoimmune abnormality (eg, lupus, rheumatoid arthritis) at study entry;
    [30] have a history of transplanted organ (corneal transplants [keratoplasty] are allowed);
    [31] have a history of an active or untreated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) during the last 5 years prior to study entry;
    [32] have a history of any other condition (eg, known drug or alcohol abuse or psychiatric disorder) at study entry, that, in the opinion of the investigator, may preclude the patient from following and completing the protocol;
    [33] have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease) at study entry;
    [34] are investigator-site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted;
    [35] are Lilly employees;
    [36] are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study);
    [37] are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study;
    [38] have previously screen failed, withdrawn, discontinued or completed this study or been randomized in any other study investigating dulaglutide.
    E.5 End points
    E.5.1Primary end point(s)
    The change in HbA1c from baseline to 24 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last patient visit week 24
    E.5.2Secondary end point(s)
    Proportion of patients with HbA1c target values of <7.0% at 24 weeks
    The change in FBG (central laboratory) from baseline to 24 weeks
    The change in body weight from baseline to 24 weeks

    Proportion of patients with HbA1c target values of ≤6.5% at 24 weeks
    The change in 6-point SMPG profile from baseline to 24 weeks
    The change in fasting glucagon from baseline to 24 weeks

    Incidence of:
    Treatment-emergent adverse events (TEAEs)
    Early discontinuations due to AEs
    Adjudicated cardiovascular and pancreatic AEs
    Thyroid neoplasms AEs
    AEs related to kidney failure, eGFR
    Systemic hypersensitivity AEs
    Local injection site reactions
    The change in systolic and diastolic blood pressure, heart rate, and lipids from baseline to 24 weeks
    Incidence and rate of hypoglycemic episodes
    Ketoacidosis, and initiation of rescue therapy for severe persistent hyperglycemia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last patient visit week 24
    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 No
    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 Yes
    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 No
    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 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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Czech Republic
    Germany
    Hungary
    Israel
    Mexico
    Spain
    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 years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 345
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 81
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 223
    F.4.2.2In the whole clinical trial 426
    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)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-03
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