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    Summary
    EudraCT Number:2008-004207-63
    Sponsor's Protocol Code Number:Protocol I1I-MC-GECD
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-25
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-004207-63
    A.3Full title of the trial
    A 12-Week, Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients with Type 2 Diabetes Mellitus
    A.4.1Sponsor's protocol code numberProtocol I1I-MC-GECD
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly and Company, Indianapolis
    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 organisation
    B.5.2Functional name of contact point
    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 nameLY2428757 for Injection, 5 mg
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY2428757
    D.3.9.3Other descriptive nameGLP-PEG, GLP-1 Analog V PEG, GLP PEG 40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Type 2 diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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 test the hypothesis that once-weekly injections of LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean HbA1c from baseline to endpoint at 12 weeks as compared to placebo.
    E.2.2Secondary objectives of the trial
    •Evaluate the safety and tolerability of LY2428757 given once-weekly for 12 weeks in patients with T2DM.
    •Evaluate and compare the percentage of patients requiring study discontinuation due to treatment failure for both LY2428757 and placebo.
    •Establish the dose response relationship for change in HbA1c in patients with T2DM given once-weekly LY2428757 with or without metformin.
    •Evaluate and compare the effects of LY2428757 and placebo on change in weight from baseline to endpoint.
    •Evaluate and compare the effects of LY2428757 and placebo on fasting and post-prandial plasma glucose levels and insulin secretory response.
    •Evaluate the population pharmacokinetics (popPK) and pharmacodynamics (PD) of LY2428757.
    •Evaluate the frequency and consequences of immune reactions to LY2428757.
    •Evaluate and compare the effects of LY2428757 and placebo on fasting lipid and lipoprotein values.

    For the rest of secondary objectives please refer to the protocol page 15.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Protocol Addendum I1I-MC-GECD(2), A 12-Week, Double-blind, Placebo-controlled Trial of LY2428757 in Patients with Type 2 Diabetes Mellitus, dated 11 September 2008
    The primary objective is to collect and store samples of blood, plasma, and serum for future research to evaluate genetic variants and biomarkers that may be associated with type 2 diabetes mellitus and/or response to treatment with LY2428757. The secondary objective is to utilize stored samples for future research to evaluate biomarkers of cardiovascular risk. This study is optional for patients participating in the main study.

    2. Protocol Sample Banking Addendum I1I-MC-GECD(1), A 12-Week, Double-blind, Placebo-controlled Trial of LY2428757 in Patients with Type 2 Diabetes Mellitus, dated 11 September 2008
    Eli Lilly and Company has established a program, Combined Specimen Banking (CSB), to bank samples (collectively called Banked Samples) from patients enrolled in studies sponsored by Eli Lilly and Company. The Banked Samples are collected and banked for research to identify the genes, gene products, and/or biochemical markers associated with diseases and/or response to clinical trial medication or other medication taken during the trial. For example, in Study I1I-MC-GECD (GECD), the samples collected from patients will be used to identify genetic and/or protein and/or biochemical markers related to LY2428757 and/or type 2 diabetes mellitus.
    This study is optional for patients participating in the main study.
    E.3Principal inclusion criteria
    - Have T2DM for at least 6 months before entering the trial based on the disease diagnostic criteria (World Health Organization [WHO]) classification (see Protocol Attachment GECD.3).
    - Are currently being treated with diet and exercise therapy consistent with the local standards of medical care, in the opinion of the investigator.
    - Patients may be treated with diet and exercise alone or in combination with a stable dose, at least 1000 mg/day, of metformin for at least 2 months before Visit 1.
    - Have an HbA1c value of 7% to 10% , inclusive, at Visit 1 and a fasting glucose ≤15 mmol/L (270 mg/dL) at Visit 2.
    - Men or women who are between the ages of 18 to 70 years, inclusive.
    - Women of child-bearing potential must test negative for pregnancy at the time of Visit 1 and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study, including at least 1 of the following: tubal ligation (sterilization), partner's vasectomy, intrauterine device, or hormonal treatment (combination oral contraceptives, transdermal patch, injectables, implantables, or vaginal ring). Other forms of contraception that can be combined with 1 of the above are male latex condom with or without spermicide, diaphragm with spermicide, cervical cap with spermicide, or vaginal sponge.
    - Have a body mass index (BMI) between 25 and 40 kg/m2, inclusive at Visit 1.
    - Weight stable (±5 kg) during the 3 months before Visit 1 (by patient self-report).
    - In the investigator’s opinion, are well motivated, capable, and willing to
    • perform self monitoring of blood glucose (SMBG)
    • complete study diary/ies, as required for this protocol
    • are receptive to continuing their prestudy diet, activity levels, and follow simple dietary advice as appropriate
    • comply with the required study and dosing visits.
    - 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.
    E.4Principal exclusion criteria
    - Use of insulin or any antidiabetic agent other than metformin during the 2 months before Visit (V) 1.
    - In the opinion of the investigator, have a gastrointestinal disease that significantly impacts gastric empting or motility or have undergone bariatric surgery.
    - Have had more than 1 episode of severe hypoglycemia, as defined in the Abbreviation and Definitions section of this protocol, within 6 months before entry into the study, or is currently diagnosed with having hypoglycemia unawareness.
    - Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
    -Are currently taking prescription or over-the-counter medications to
    promote weight loss.
    - Have a history of acute or chronic pancreatitis or elevation of serum lipase (greater than 2 times the upper limit of normal).
    -Women who are breastfeeding.
    - In the last 2 years, have known or suspected cardiac autonomic neuropathy, based on clinical signs, symptoms, or appropriate diagnostic testing.
    - Have cardiac disease with functional status that is NYHA Class II, III, or IV or a history of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure in the past 6 months.
    - Have poorly controlled hypertension at V1 or V2, malignant hypertension, renal artery stenosis, and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization.
    -Have resting tachycardia at V1 or V2 or a history of a supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia that, in the opinion of the investigator, may preclude the patient from participating in the protocol.
    - Have an EKG considered by the investigator to be outside of normal limits and relevant for interpretation or indicating cardiac disease at V1. The following conduction abnormalities may confound QTc analysis and should be avoided: second- or third-degree atrioventricular block, delayed intraventricular conduction with QRS >120 msec, left bundle branch block, complete right bundle branch block, or Wolff-Parkinson-White. A QTc interval greater than450 msec in men and greater than 470 in women or a PR interval more than 220 msec are specifically excluded.
    - Personal or family history of long QT syndrome, family history of sudden death in a first-degree relative before age 40, or personal history of unexplained syncope within the last year. Use of prescription or over-the-counter medications known to prolong the QT or QTc interval.
    - Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase or aspartate aminotransferase levels >2.5 times the upper limit of the reference range at V1.
    - Have a serum creatinine >2 mg/dL or, in patients being treated with metformin, a serum creatinine above what is approved in the metformin product labeling in the respective country.
    - Have severe hypertriglyceridemia at V1. If taking lipid-lowering agents, doses of these medications must be stable for 30 days before randomization.
    - Evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone result at V1 and which, in the opinion of the investigator, would confound data interpretation or pose a risk to patient safety. Subjects on a stable dose of thyroid replacement therapy may be eligible if they meet the other criteria.
    - Have a history of a transplanted organ.
    - Evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator at V1.
    - Have been diagnosed with HIV and/or have positive human HIV antibodies.
    - Are receiving chronic (>2 weeks) systemic glucocorticoid therapy or have received such therapy within 4 weeks immediately before V2.
    - Have an active or untreated malignancy or have been 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) for less than 5 years.
    - Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, may preclude the patient from following and completing the protocol.
    - Are currently taking central nervous system stimulant with the exception of caffeinated beverages.
    - Investigator site personnel directly affiliated with this study and their immediate families.
    - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    E.5 End points
    E.5.1Primary end point(s)
    The change in HbA1c, from baseline to endpoint, is the primary efficacy measure. Baseline is the Visit 3 HbA1c measurement. Endpoint will be the Visit 9 HbA1c measurement (12-week clinic visit). If a patient discontinues before study completion, then the last observed HbA1c measurement postrandomization will be used as endpoint.
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    End of study (trial) is defined as the date of the last clinic visit or last scheduled procedure at the last site shown in the Study Schedule for the last active subject in the study.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 300
    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 Decision2009-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-11
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