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    Summary
    EudraCT Number:2016-002494-34
    Sponsor's Protocol Code Number:H9X-MC-GBGJ(a)
    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:2016-10-25
    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 number2016-002494-34
    A.3Full title of the trial
    A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses versus Placebo in Patients with Type 2 Diabetes on Metformin Monotherapy
    Studie fáze 2, dvojitě zaslepená, placebem kontrolovaná, trvající 18 týdnů,
    porovnávající různé dávky dulaglutidu s placebem u pacientů s diabetem 2.
    typu, kteří jsou na monoterapii s metforminem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses versus Placebo in Patients with Type 2 Diabetes on Metformin Monotherapy
    A.4.1Sponsor's protocol code numberH9X-MC-GBGJ(a)
    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
    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.3.1Product nameTrulicity
    D.3.2Product code LY2189265
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.3Other descriptive nameDULAGLUTIDE
    D.3.9.4EV Substance CodeSUB130484
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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 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.3.1Product nameTrulicity
    D.3.2Product code LY2189265
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.3Other descriptive nameDULAGLUTIDE
    D.3.9.4EV Substance CodeSUB130484
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 syringe
    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
    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 19.1
    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
    To show superiority of the 3 dulaglutide doses, including the two higher doses (4.5 mg and 3.0 mg) and the approved 1.5 mg dose to placebo in change in HbA1c.
    E.2.2Secondary objectives of the trial
    To determine if the two higher doses of Trulicity are effective and safe.
    Efficacy: To compare each dulaglutide arm (4.5 mg, 3.0 mg, 1.5 mg) to the placebo arm at 18 weeks for secondary efficacy parameters.
    Safety: To compare each dulaglutide arm (4.5 mg, 3.0 mg, 1.5 mg) to the placebo arm for selected safety parameters at 18 weeks.
    PK/PD: To characterize the pharmacokinetics (PK) of  dulaglutide and establish the relationships between dose/exposure and key safety and efficacy measures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Have had T2D for ≥6 months according to the World Health Organization (WHO) classification;
    Have HbA1c of 7.0% to 10.0%, inclusive;
    Have been treated with stable doses of metformin for at least 3 months (dose of ≥1500 mg/day) and the maximum-approved dose per country-specific label; lower doses will be allowed only with documented GI intolerability in the required dose range;
    Have had stable body weight for at least 3 months; body weight will be considered stable if it has not changed more than 5% in the past 3 months;
    Agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment;
    Have a body mass index (BMI) ≥25 kg/m2;  
    In the investigator’s opinion, are well motivated, capable, and willing to:
    [a]  self-inject treatment;
    [b]  perform fingerstick plasma glucose (PG) monitoring at least once daily and up to 6 times per day once weekly throughout the trial;
    [c]  maintain a study diary as required for this protocol.
    E.4Principal exclusion criteria
    [13] have type 1 diabetes (T1D);
    [14] have been treated with any excluded medication within 3 months prior to screening and/or between study entry and randomization; excluded glucocorticoids must not have been used for ≤14 days within 1 month prior to Visit;
    [15] have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any GLP-1 RAs at any time in the past. Short-term use of insulin for acute conditions is allowed ( >14 days);
    [16] have a condition that is a contraindication for use of the GLP-1 RA class or metformin;
    [17] have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma;
    [18] have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemia unawareness within the 6 months;
    [19] have had any of the following CV conditions: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke);
    [20] have a 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 (eg, Lap-Band®);
    [21] have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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;
    [22] have had chronic or acute pancreatitis any time prior to study entry;
    [23] 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
    [24] have a personal or family history of medullary thyroid carcinoma (MTC) or personal history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
    [25] have serum calcitonin ≥20 pg/mL, as determined by the central laboratory at study entry;
    [26] have evidence of significant, active autoimmune abnormality (eg, lupus, rheumatoid arthritis);
    [27] have a history of 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 past 5 years;
    [28] any serious disease or other condition (e.g, known drug or alcohol abuse) which, in the opinion of the investigator, would pose a significant risk to the patient or interfere with the interpretation of safety, efficacy, or PD data;
    [29] have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease);
    [30] 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);
    [31] 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;
    [32] are Lilly employees;
    [33] have participated, within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed;
    [34] have previously completed or withdrawn from this study or any other study investigating dulaglutide;
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 18 weeks
    E.5.2Secondary end point(s)
    • Proportion of patients achieving HbA1c target of <7.0%
    • The change in fasting serum glucose (FSG; central laboratory) from baseline
    • The change in body weight from baseline
    • Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
    • Discontinuation of study drug due to adverse events (AEs)
    • Incidence and rate of hypoglycemia (severe, total, documented symptomatic, and nocturnal)
    • PK parameters (eg, Cmax, AUC)
    • Pharmacodynamic evaluations will include HbA1c, FSG, body weight, QTcF interval, and heart rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    • 18 weeks
    • Baseline and 18 weeks
    • Baseline and 18 weeks
    • Baseline through 18 weeks
    • 18 weeks
    • 18 weeks
    • Week 0 through week 22
    • Week 0 through week 22
    •
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 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 trial4
    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 concerned6
    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
    Czech Republic
    Mexico
    Poland
    Romania
    United States
    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 months9
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days14
    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: 242
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 137
    F.4.2.2In the whole clinical trial 302
    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)
    No treatment is planned per protocol. Patient will continue on "their metformin" and standard of care as directed by their physician.
    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 Decision2016-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-14
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