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    Summary
    EudraCT Number:2009-012011-17
    Sponsor's Protocol Code Number:H8O-MC-GWDE
    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:2009-09-22
    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 number2009-012011-17
    A.3Full title of the trial
    Safety and Efficacy of Exenatide Once Weekly versus Liraglutide in subjects with type 2 diabetes and inadequate glycemic control treated with lifestyle modification and oral antidiabetic medications
    A.3.2Name or abbreviated title of the trial where available
    GWDE
    A.4.1Sponsor's protocol code numberH8O-MC-GWDE
    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 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 nameExenatide
    D.3.2Product code LY2148568, AC2993
    D.3.4Pharmaceutical form Powder and solvent for suspension 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 codeAC2993, LY2148568
    D.3.9.3Other descriptive nameexendin-4,exendin 4, exenatide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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.IMP: 2
    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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    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 nameliraglutide
    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.3.11 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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes
    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 is to compare the difference in change in HbA1c from baseline to treatment endpoint (26 weeks) between 2 mg exenatide once weekly and 1.8 mg once-daily liraglutide in subjects with type 2 diabetes and inadequate glycemic control with lifestyle modification and oral antidiabetic agents (OADs) (metformin, SU, metformin plus an SU, or metformin plus pioglitazone).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare exenatide once weekly to once-daily liraglutide over 26 weeks with respect to:
    • the proportion of subjects achieving HbA1c </= 7% and </=6.5%
    • fasting serum glucose
    • change in body weight
    • serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides(TG), calculated low-density lipoprotein cholesterol [LDL-C])
    • safety and tolerability
    • hypoglycemia
    • subject-reported health outcomes
    • change in systolic blood pressure (SBP) and diastolic blood pressure (DBP), as measured while the subject is seated
    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 Sample Storage Addendum H8O-MC-GWDE(1): "Safety and Efficacy of Exenatide Once Weekly versus Liraglutide in Subjects with Type 2 Diabetes and Inadequate Glycemic Control Treated with Lifestyle Modification and Oral Antidiabetic Medications" September 2009.
    The primary objective is to collect and store blood for research into biomarkers associated with type 2 diabetes mellitus and treatment with exenatide and/or liraglutide.
    2) Protocol DNA Stored Sample Addendum H8O-MC-GWDE(2) : "Safety and Efficacy of Exenatide Once Weekly versus Liraglutide in Subjects with Type 2 Diabetes and Inadequate Glycemic Control Treated with Lifestyle Modification and Oral Antidiabetic Medications" September 2009.
    The primary objective is to collect and store blood for research into genetics associated with type 2 diabetes mellitus and treatment with exenatide and/or liraglutide.
    E.3Principal inclusion criteria
    Subjects (males or females) are eligible to be included in the study only if they meet all of the following criteria:
    [1] Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)
    [2] Are at least 18 years of age at screening.
    [3] Have suboptimal glycemic control as evidenced by an HbA1c measurement at Visit 1 between 7.1% and 11.0%, inclusive.
    [4] Have a body mass index (BMI) ≤45 kg/m2.
    [5] Have a history of stable body weight (not varying by >5%) for at least 3 months prior to Visit 1.
    [6] Have been treated with lifestyle modification (diet and exercise) and with one of the following single OADs or combinations of OADs administered at maximum tolerated dose: metformin, SU, metformin plus an SU, metformin plus pioglitazone
    According to the following parameters:
    • Subjects taking metformin or SU must have been taking the medication(s) for at least 3 months (stable dose for at least 8 weeks) prior to Visit 1.
    • Subjects taking pioglitazone must have been taking the medication for at least 4 months (stable dose for at least 12 weeks) prior to Visit 1.
    If combination OAD preparations are used, the total daily dose of each component must meet the criteria outlined above.
    [7] This inclusion criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year post menopause) only.
    • Are not breastfeeding.
    • Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
    • Intend not to become pregnant during the study.
    • Have practiced a reliable method of birth control (e.g., use of oral contraceptives or approved hormonal implant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly, condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for at least 6 weeks prior to screening.
    • Agree to continue to use a reliable method of birth control (see above) during the study, as determined by the investigator.
    E.4Principal exclusion criteria
    [8] Are Lilly, Amylin, or Alkermes employees.
    [9] Are investigator site personnel directly affiliated with this study and/or their immediate families.
    [10] Presence of active cardiac disease within 3 months of Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study. Subjects with stable cardiac disease are not excluded.
    [11] Presence or history of severe congestive heart failure (New York Heart Association Class IV [CCNYHA 1994]). Either the protocol or local label for the concomitant OADs should be followed, whichever is more restrictive.
    [12] Have clinically significant history or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis, or pyloric stenosis, or subjects who have had gastric bypass surgery or gastric banding surgery.
    [13] Have a presence of medullary carcinoma or MEN II (multiple endocrine neoplasia) OR have a family history of medullary carcinoma or MEN II.
    [14] Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine aminotransaminase (ALT), or serum glutamic pyruvic transaminase (SGPT) greater than three times the upper limit of the reference range. More stringent local label exclusions may apply.
    [15] Have a history of renal transplantation, or are currently receiving renal dialysis, or have an estimated creatinine clearance <60 mL/min as calculated using the Cockroft-Gault equation. If taking metformin, have serum creatinine ≥1.5 mg/dL (132 micromol/L) for males and ≥1.4 mg/dL (110 micromol/L) for females. Either the protocol or local label for concomitant OADs should be followed, whichever is more restrictive.
    [16] Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
    [17] Have a history of, or currently have, acute or chronic pancreatitis.
    [18] Have known hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females) or any other condition known to interfere with the HbA1c methodology.
    [19] Have ≥2 episodes of major hypoglycemia within 6 months prior to Visit 1.
    [20] Have any contraindication, allergy, or hypersensitivity for the study drug (exenatide once weekly or liraglutide), exenatide twice daily, the OAD(s) being used, or the excipients contained in these agents.
    [21] If taking metformin and have a contraindication to metformin use
    [22] Have been treated within 8 weeks of Visit 1 with systemic glucocorticoid therapy by oral, intravenous, intra-articular, or intramuscular route.
    [23] Have been treated with drugs that promote weight loss within 3 months of Visit 1.
    [24] Have taken any of the following excluded medications for more than 1 week within the 3 months prior to Visit 1, or have taken any of the following excluded medications within 1 month prior to Visit 1.
    • Insulin
    • Alpha-glucosidase inhibitors
    • Meglitinides
    • Byetta
    • Dipeptidyl peptidase (DPP)-4 inhibitors
    • Symlin (pramlintide acetate)
    [25] Have had an organ transplant.
    [26] Have donated blood within 30 days prior to Visit 1 or have had a blood transfusion or severe blood loss within 3 months prior to Visit 1.
    [27] Have had poorly controlled blood pressure (≥160 mm Hg, systolic value; and/or ≥110 mm Hg, diastolic value) within the last 4 weeks of Visit 1 or have had changes in the blood pressure medications within 8 weeks of Visit 2.
    [28] Have had changes in lipid lowering medications within 8 weeks prior to Visit 2 (if taking niacin, within 6 months prior to Visit 2).
    [29] Have a serum triglyceride level ≥1000 mg/dL (≥11.3 mmol/L).
    [30] Meet any exclusion criteria required by local law.
    [31] Have taken exenatide once weekly, exenatide twice daily, or liraglutide, or have participated in this study or any other study investigating exenatide or liraglutide.
    [32] Are currently enrolled in, or discontinued within the last 30 days or longer if required by local guidelines, from a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    [33] Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that renders subjects unable to understand the nature, scope, and possible consequences of the study or precludes them from following and completing the protocol, in the opinion of the investigator.
    [34] Fail to satisfy the investigator regarding suitability to participate for any other reason.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is change in HbA1c.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 EEA73
    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 months6
    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 months6
    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.1.3Elderly (>=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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 907
    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 Decision2009-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-07
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