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    Summary
    EudraCT Number:2012-004229-25
    Sponsor's Protocol Code Number:H9X-MC-GBDI
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-27
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2012-004229-25
    A.3Full title of the trial
    A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg with Placebo on Glycemic Control in Patients with Type 2 Diabetes on Basal Insulin Glargine
    (AWARD-9: Assessment of Weekly AdministRation of LY2189265 in Diabetes-9)
    Randomizovaná, dvojitě zaslepená studie porovnávající vliv 1.5 mg dulaglutidu a placeba na glykemickou kontrolu u pacientů s diabetem 2. typu užívajících bazální inzulín glargin (AWARD-9: Hodnocení týdenního podání LY2189265 u diabetu – 9)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for patients with Type 2 Diabetes currently taking insulin glargine with or without metformin.
    A.3.2Name or abbreviated title of the trial where available
    AWARD-9
    A.4.1Sponsor's protocol code numberH9X-MC-GBDI
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityDC 1526 Indianapolis
    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 No
    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 namedulaglutide
    D.3.2Product code LY2189265
    D.3.4Pharmaceutical form Solution for injection
    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 INNDulaglutide
    D.3.9.2Current sponsor codeLY2189265
    D.3.9.3Other descriptive nameDULAGLUTIDE
    D.3.9.4EV Substance CodeSUB28985
    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.3.11 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 Yes
    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 placeboSolution for injection
    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
    Diabetes Mellitus, Type 2
    E.1.1.1Medical condition in easily understood language
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to show superiority of the addition of once weekly dulaglutide 1.5 mg compared to the addition of once weekly placebo to titrated basal insulin glargine, with or without metformin, on change from baseline in HbA1c after 28 weeks of treatment in patients with Type 2 Diabetes Mellitus.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objectives:
    Compare 2 groups at 28 weeks on:
    • % of patients at HbA1c <7.0% or ≤6.5%
    • % of patients at HbA1c <7.0% & without weight gain (<0.1 kg) at 28 weeks & without documented symptomatic hypoglycemia during maintenance period;
    • % of patients at HbA1c <7.0% at 28 weeks & without documented symptomatic hypoglycemia during maintenance period;
    • % of patients at HbA1 <7.0% & without weight gain (<0.1 kg);
    • Changes from baseline in: fasting serum glucose, plasma glucose from daily self-monitored plasma glucose profiles, body weight, daily mean glargine doses.

    Secondary Safety Objectives:
    Compare 2 groups at 28 weeks on incidence of:
    • Adjudicated deaths & nonfatal major CV events;
    • Self-reported hypoglycemic events & of patients discontinuing study due to severe, persistent hyperglycemia;
    • Pancreatitis confirmed by adjudication;
    • Thyroid neoplasms;
    • Dulaglutide anti-drug antibodies & of allergic & hypersensitivity reactions.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Where local regulations and ERBs allow, a blood sample will be collected for pharmacogenetic and biomarker analysis.
    E.3Principal inclusion criteria
    Male or female patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] are men or non-pregnant women aged ≥18 years at screening
    [2] have type 2 diabetes (based on the World Health Organization’s [WHO] diagnostic criteria);
    [3] have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening
    [4] doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Insulin glargine dose is considered stable when all doses during this period are within the range defined by ±10% of the most commonly used insulin glargine dose during this same period if that dose is ≥40 IU; if the most commonly used insulin glargine dose is <40 IU, then all doses for that period must be within the ±4 IU range of the most commonly used dose. Doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (≥1500 mg/day) and the maximum approved dose per the locally-approved label;
    [5] have an HbA1c value ≥7.0% and ≤10.5% as assessed by the central laboratory at screening;
    [6] require further insulin glargine dose increase at randomisation per the TTT algorithm based on the SMPG data collected during the prior week;
    [7] have stable weight (±5%) ≥3 months prior to screening;
    [8] have body mass index (BMI) ≤45 kg/m2 at screening;
    [9] are able and willing to administer once weekly randomized therapy;
    [10] in the investigator’s opinion, are well motivated, capable, and willing to:
    [a] perform fingerstick PG monitoring, including scheduled PG profile with up to 7 measurements in 1 day;
    [b] learn how to self-inject treatment as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study drug);
    [c] maintain a study diary as required for this protocol;
    [11] Are females of childbearing potential (a woman will be considered of childbearing potential if she is not surgically sterilized or if she is between menarche and 1-year postmenopausal [2-years postmenopausal if <50 years of age]) who must:
    [a] Test negative for pregnancy at screening, based on a serum pregnancy test;
    [b] Agree to use a reliable method of birth control (eg, use of oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices]; partner with vasectomy; or abstinence if consistent with lifestyle) during the study and for 1 month following the last dose of study drug; and
    [c] Not be breastfeeding.
    [12] Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site;
    [13] Have a sufficient understanding of the primary language of the country such that they will be able to complete the patient questionnaires.
    E.4Principal exclusion criteria
    Patients excluded from study if meet following criteria at screening, or when indicated below for specific criteria, at randomization/baseline, or any time during screening & lead-in periods:
    • have type 1 diabetes mellitus
    • treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with/without metformin, within 3 months prior to screening or during lead-in period
    • per TTT algorithm, do not require insulin glargine dose increase at randomisation based on SMPG data collected during prior week
    • history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
    • history of hypoglycemia unawareness within 6 months prior to screening
    • treated with drugs promoting weight loss within 3 months prior to screening or during lead in period
    • receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have received such therapy within 4 weeks prior to screening or during lead in period
    • had any of following CV conditions within 2 months prior to screening: acute myocardial infarction , New York Heart Association Class III or IV heart failure, or cerebrovascular accident
    • have known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
    • have acute or chronic hepatitis, signs & symptoms of any other liver disease, or alanine aminotransferase (ALT) level >2.5 times upper limit of reference range, determined by central laboratory (patients with nonalcoholic fatty liver disease eligible)
    • history of chronic pancreatitis or acute idiopathic pancreatitis, or diagnosed with any type of acute pancreatitis within 3 months prior to screening
    • estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by central laboratory; for patients on metformin, have renal disease or renal dysfunction (eg. a serum creatinine ≥1.5 mg/dL [male] or ≥1.4 mg/dL [female] or eGFR [CKD-EPI] <60 mL/min/1.73 m2) (metformin SPC, 2008; Glucophage® USPI, 2009)
    • have evidence of significant, uncontrolled endocrine abnormality (eg, thyrotoxicosis, adrenal crisis), in opinion of investigator
    • any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in absence of known C-cell hyperplasia (exclusion includes patients with family history of MEN 2A or 2B, whose family history for the syndrome is rearranged during transfection [RET]-negative; only exception for this exclusion will be for patients whose family members with MEN 2A or 2B have known RET mutation & potential patient for study is negative for RET mutation)
    • any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
    • serum calcitonin ≥20 pg/mL, determined by central laboratory
    • evidence of significant, active autoimmune abnormality
    • any other condition not listed in this section that is contraindication for use of insulin glargine, or, for patients using metformin, have a condition that is contraindication for use of metformin & would require metformin discontinuation per label
    • history of transplanted organ (corneal transplants [keratoplasty] are allowed)
    • history of active or untreated malignancy, or are in remission from clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of cervix, or in situ prostate cancer) during 5 years prior to screening
    • history of any other condition (eg, known drug or alcohol abuse or psychiatric disorder), which, in opinion of investigator, may preclude patient from following & completing protocol
    • any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease)
    • investigator site personnel directly affiliated with this study and/or their immediate families (immediate family is defined as spouse, parent, child, or sibling, whether biological or legally adopted)
    • Lilly employees
    • currently enrolled in or discontinued within 30 days prior to screening from a clinical trial involving an off-label use of an investigational drug or device (other than study drug/device used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. If previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
    • previously screen failed, withdrawn, discontinued from, or completed this study or been randomized in any clinical trial of dulaglutide
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 weeks
    E.5.2Secondary end point(s)
    Compare 2 groups at 28 weeks on:
    • Percentage of patients at HbA1c <7.0% or ≤6.5%
    • Percentage of patients at HbA1c <7.0% & without weight gain (<0.1 kg) at 28 weeks & without documented symptomatic hypoglycemia during maintenance period;
    • Percentage of patients at HbA1c <7.0% at 28 weeks & without documented symptomatic hypoglycemia during maintenance period
    • Percentage of patients at HbA1 <7.0% & without weight gain (<0.1 kg)
    • Changes from baseline in: fasting serum glucose, plasma glucose from daily self-monitored plasma glucose profiles, body weight, daily mean glargine doses
    • Confirmed by adjudication:
    a. Deaths
    b. Non-fatal major cardiovascular events
    c. Confirmed pancreatitis cases
    d. Presence of thyroid neoplasms
    • Incidence of dulaglutide anti-drug antibodies & of allergic & hypersensitivity reactions.
    • Incidence of self-reported hypoglycemic events & of patients discontinuing study due to severe, persistent hyperglycemia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 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 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 trial2
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Czech Republic
    Hungary
    Italy
    Spain
    United Kingdom
    United States
    United States Minor Outlying Islands
    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 months4
    E.8.9.1In the Member State concerned days15
    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 days15
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 92
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 308
    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)
    Study treatment will stop when patients complete active treatment period (28 weeks) or when patients discontinue study early. After study treatment is discontinued, an appropriate diabetes treatment regimen will be initiated by the investigator. The study sponsor will not provide the patients with ongoing supplies of study medication after the patients have ceased study treatment.
    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 Decision2014-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-05
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