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    Summary
    EudraCT Number:2008-003843-36
    Sponsor's Protocol Code Number:H8O-US-GWCO
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-003843-36
    A.3Full title of the trial
    A Randomized Trial Comparing Exenatide with Placebo in Subjects with Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications
    A.3.2Name or abbreviated title of the trial where available
    GWCO
    A.4.1Sponsor's protocol code numberH8O-US-GWCO
    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
    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 Yes
    D.2.1.1.1Trade name Byetta
    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 nameExenatide
    D.3.2Product code LY2148568
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNexenatide
    D.3.9.1CAS number 141732-76-5
    D.3.9.2Current sponsor codeLY2148568
    D.3.9.3Other descriptive nameexendin-4, exendin 4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    to test the hypothesis that twice daily exenatide plus titration of basal insulin is superior to placebo plus titration of basal insulin on glycemic control as measured by change in A1C from baseline (Visit 3) to Week 30, with or without oral antihyperglycemic medications (OAMs) in adult subjects with T2DM who are suboptimally controlled (A1C ≥7.1% and ≤10.5%).
    E.2.2Secondary objectives of the trial
    to compare the efficacy and safety of exenatide to placebo when added to basal insulin glargine with or without OAMs with respect to:
    • percentage of subjects with A1C ≤7.0% and A1C ≤6.5% at 30 weeks;
    • change from baseline in fasting glucose;
    • 7-point self-monitored blood glucose (SMBG) profiles and mean blood glucose (BG) measurement based on 7-point SMBG;
    • change from baseline in fasting total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides;
    • change from baseline in body weight (kg);
    • change from baseline in waist circumference (cm);
    • change from baseline in insulin dose (24-hour total international units [IU]
    and total units/kg body weight);
    • change from baseline in seated systolic (SBP) and diastolic blood pressure (DBP);
    • safety, as measured by:
    o self-reported hypoglycemic episodes;
    o treatment-emergent adverse events (TEAEs);
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Addendum (1), 26 June 2008: Sample Banking Addendum
    The Banked Samples are collected and banked for research to identify the genes associated with diseases and/or response to clinical trial medication or other medication taken during the trial.The research performed on the Banked Samples is limited to the clinical information collected on the case report form (CRF) and provided by laboratory analysis. Information regarding these genetic factor(s) may benefit subjects in the future through the development of new and more specific therapeutics developed as a result of genetic analyses.
    Although the Banked Sample(s) will be stored for research purposes, the sample(s) will be used only until the Banked Sample(s) collected in the trial is/are exhausted. The blood cells will not be made to grow indefinitely in the laboratory (immortalized).
    There is an anonymization process.
    E.3Principal inclusion criteria
    [1] Have T2DM
    [2] Are at least 18 years of age
    [3] Have been taking basal insulin glargine at a dose of ≥20 units/day for at least 3 months prior to Visit 1
    [4] Have been receiving glargine alone or in combination with one of the following OAM regimens for the 3 months prior to Visit 1:metformin,pioglitazone, a combination of metformin and a pioglitazone at a stable dose for 6 weeks prior to Visit 1 and do not meet exclusion criteria 11.
    [5] Have an A1C ≥7.1% and ≤10.5%.
    [6] Have a body mass index (BMI) ≤45 kg/m2.
    [7] Show no evidence of cardiovascular disease as determined by a normal electrocardiogram (ECG)
    [8] Have a history of stable body weight
    [9] Liver enzyme tests (ALT, AST) are not greater than 1.5 times the upper limit of the reference range
    [10] Are female subjects with serum creatinine level ≤1.4 mg/dL or male
    subjects with serum creatinine level ≤1.5 mg/dL.
    E.4Principal exclusion criteria
    [11] Are currently taking a dose or combination of OAM that is not allowed with concurrent use of insulin glargine per local product label
    [12] Have taken any glucose-lowering medications not included in
    Inclusion Criteria [3] and [4] in the 3 months prior to Visit 1 for more than 1 week or within 1 month of screening.
    [13] Have taken any insulin other than glargine within the 3 months prior to Visit 1 for more than 1 week or within 1 month of screening
    [14] Have had more than one episode of major hypoglycemia, within 6 months prior to Visit 1
    [15] Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
    [16] Women who are breastfeeding.
    [17] presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic,
    gastrointestinal disease, or any other serious disease
    [18] Have a history of renal transplantation or receiving dialysis
    [19] Are subjects with a malignancy (see protocol for specifics)
    [20] Have contraindication or known hypersensitivity or allergy to exenatide or to any of the product components
    [21] Have used a drug for weight loss within 3 months prior to Visit 1 for more than 1
    week or within 1 month of screening
    [22] Are currently on a supervised weight-loss program
    [23] Have had a blood transfusion or severe blood loss within 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other condition known to interfere with the A1C methodology.
    [24] Are receiving chronic systemic glucocorticoid therapy or have received such therapy within the 8 weeks immediately preceding Visit 1.
    [25] Have an irregular sleep/wake cycle
    [26] Have any other condition that renders the subject unable to understand the
    nature, scope, and possible consequences of the study,
    [27] Have received treatment within 30 days before Visit 1 with a drug that has not received regulatory approval for any indication at the time of study entry.
    [28] Are investigator site personnel directly affiliated with this study and/or their immediate families.
    [29] Are employed by Lilly or Amylin Pharmaceuticals, Inc.
    [30] Have previously completed or withdrawn from this study after signing
    the ICD.
    [31] If on metformin and have contraindication to metformin use
    [32] If on metformin, have had a radiologic contrast study performed within 48 hours prior to Visit 1.
    [33] If on pioglitazone, have a contraindication to pioglitazone including NYHA Class II-IV CHF or are on a dose of pioglitazone that is contraindicated with insulin in that country.
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis variable is the change in A1C, and the primary analysis set is FAS. The conclusion for the primary analysis will be based on the pvalue for the test of treatment effect at 30 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 No
    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.8.3 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 EEA10
    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 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
    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 months10
    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 months10
    E.8.9.2In all countries concerned by the trial days1
    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.1.3Elderly (>=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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 260
    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 Decision2008-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-04
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