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    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-004179-33
    Sponsor's Protocol Code Number:I8F-MC-GPGB
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-26
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2016-004179-33
    A.3Full title of the trial
    A Phase 2 Study of Once-Weekly LY3298176 Compared with Placebo and Dulaglutide in Patients with Type 2 Diabetes Mellitus
    Klinické skúšanie fázy 2 porovnávajúce LY3298176 podávané raz týždenne s placebom a dulaglutidom u pacientov s diabetom 2. typu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial comparing the effects of experimental drug versus placebo and an approved drug in once-weekly dosing for patients diagnosed with Type 2 Diabetes Mellitus.
    A.4.1Sponsor's protocol code numberI8F-MC-GPGB
    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 RoleComparator
    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.3.8INN - Proposed INNDULAGLUTIDE
    D.3.9.3Other descriptive nameDULAGLUTIDE
    D.3.9.4EV Substance CodeSUB130484
    D.3.10 Strength
    D.3.10.1Concentration unit mg/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 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 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 nameLY3298176
    D.3.4Pharmaceutical form Powder 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 INNLY3298176
    D.3.9.3Other descriptive nameLY3298176
    D.3.9.4EV Substance CodeSUB186887
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    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 Mellitus, Type 2
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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 demonstrate a dose-response relationship of once-weekly subcutaneous (SC) injections of LY3298176 on hemoglobin A1c (HbA1c) change from baseline relative to placebo, in patients with T2DM inadequately controlled with diet and exercise alone or treated with a stable dose of metformin.
    E.2.2Secondary objectives of the trial
    To determine the effect of LY3298176 versus dulaglutide (and to compare the effect of each versus placebo) on:
    •The mean body weight change from baseline to 12 and 26 weeks
    •The percentage of patients with 5% or greater body weight loss at 26 weeks
    •The change from baseline of HbA1c at 12 weeks
    •The percentage of patients with 10% or greater body weight loss at 26 weeks
    •The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0%
    •The change from baseline of fasting blood glucose (FBG) at 12 and 26 weeks
    •The change from baseline to 26 weeks in high-density lipoprotein cholesterol, total cholesterol, triglycerides, and low-density lipoprotein cholesterol
    •The waist circumference
    Safety and tolerability, including gastrointestinal tolerability, incidence and rate of hypoglycemia, hypersensitivity reactions, and pancreatic safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Have T2DM for at least 6 months before screening based on the disease diagnostic criteria (According to World Health Organization [WHO] Classification).
    •Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening. Note: patients from some countries may be required to be on metformin in order to enroll in the protocol, per EU directive CHMP/EWP/1080/00 Rev.1.
    •Male or female patients 18 to 75 years of age, inclusive
    •Male patients: Male patients should be willing to use reliable contraceptive methods throughout the study and for at least 3 months after last injection
    •Female patients: Female patients must not be of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
    Women with an intact uterus are deemed postmenopausal if they are ≥45 years old, and
    have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year, OR
    have had at least 6 months of amenorrhea with follicle-stimulating hormone (FSH) and estradiol levels consistent with a postmenopausal state (FSH ≥40mIU/mL and estradiol ≤30 pg/mL).

    Women of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
    • test negative for pregnancy at Screening based on a serum pregnancy test AND
    • if sexually active, agree to use either 1 highly effective form of contraception or 2 effective forms of contraception for the duration of the trial and up to 30 days thereafter.
    • not be breastfeeding.
    •Have a BMI between 23 and 50 kg/m2 (inclusive) at screening.
    •Informed Consent
    In the investigator’s opinion, are well motivated, capable, and willing to:
    • perform self-monitoring of blood glucose (SMBG)
    • self-inject up to 4 injections each week
    • complete study diary/ies, as required for this protocol
    • prepare and administer (with assistance if necessary) study medication
    • are receptive to continuing their pre-study diet, activity levels, and follow simple dietary advice as appropriate
    •Be willing to maintain metformin dose during the trial, if taking a stable dose of metformin at study entry. Patients experiencing hypoglycemia during the study may have their metformin dose reduced.
    E.4Principal exclusion criteria
    Medical Conditions
    •Have type 1 diabetes mellitus.
    •Have uncontrolled diabetes defined as more than 2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening Visit.
    •Have had more than 1 episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Any patient that the investigator feels will not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded.
    •Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (greater than 2 times the upper limit of normal [ULN]) or fasting serum triglyceride level of >500 mg at screening.
    •Have a diagnosis of gastroparesis or history of bariatric surgery or a clinically significant gastric emptying abnormality, in the opinion of the investigator.
    •Have active proliferative diabetic retinopathy.
    •Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, a history of pancreatitis, or alanine transaminase (ALT) levels >2.5 times the upper limit of the reference range at Screening, as determined by the central laboratory at screening.
    •Have a known self or family history of multiple endocrine neoplasia (MEN) type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
    •Evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone (TSH) which, in the opinion of the investigator, would pose a risk to patient safety. Subjects on a stable dose of thyroid replacement therapy for at least the prior 3 months who are clinically euthyroid and who are anticipated to remain on this dose throughout the trial period may be eligible if they meet the other criteria.
    •Have a screening calcitonin ≥20 pg/mL as determined by the central laboratory at Screening.
    •Have an electrocardiogram (ECG) considered by the investigator indicative of active cardiac disease or with abnormalities that may interfere with the interpretation of changes in ECG intervals at screening.
    A QTc interval greater than 450 msec in men and greater than 470 in women is specifically excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The change in HbA1c from baseline to 26 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 26 weeks
    E.5.2Secondary end point(s)
    The change in mean body weight from baseline to 12 and 26 weeks
    • The percentage of patients with 5% or greater body weight loss from baseline to 26 weeks
    • The change in HbA1c from baseline to 12 and 26 weeks
    • The percentage of patients with 10% or greater body weight loss from baseline to 26 weeks
    • The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0%.
    • The change in fasting blood glucose from baseline to 12 and 26 weeks
    • The change in lipid laboratory data from baseline to 26 weeks
    • The change in SMBG profile from baseline to 4, 12 and 26 weeks
    • Change from baseline to 12 and 26 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Week 12, Week 26
    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 No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 EEA9
    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
    Mexico
    Poland
    Slovakia
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 300
    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)
    None.
    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 Decision2017-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-28
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