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    Summary
    EudraCT Number:2009-014986-22
    Sponsor's Protocol Code Number:NC25113
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-12-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2009-014986-22
    A.3Full title of the trial
    A randomized double blind, placebo-controlled clinical trial to assess the effects of taspoglutide (RO5073031) on cardiovascular outcomes in subjects with inadequately controlled type 2 diabetes and established cardiovascular disease
    A.3.2Name or abbreviated title of the trial where available
    EMERGE 8
    A.4.1Sponsor's protocol code numberNC25113
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 nameTaspoglutide
    D.3.2Product code RO5073031/F04-04
    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 INNTaspoglutide
    D.3.9.1CAS number 275371-94-3
    D.3.9.2Current sponsor codeRO5073031/F04-04
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameTaspoglutide
    D.3.2Product code RO5073031/F04-01
    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 INNTaspoglutide
    D.3.9.1CAS number 275371-94-3
    D.3.9.2Current sponsor codeRO5073031/F04-01
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Patients with Type 2 diabetes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 determine the effect of taspoglutide in addition to standard of care on cardiovascular outcomes in type 2 diabetic subjects with established cardiovascular disease in order to rule out an unacceptable (80%) increase in cardiovascular events.
    E.2.2Secondary objectives of the trial
    To assess the effects of taspoglutide in addition to standard of care on:
    • A secondary CV composite endpoint: the individual components of the composite primary endpoint plus any revascularization procedure and hospitalization for other CV events
    • Each of individual components of the composite CV primary endpoint
    • Total mortality
    • Metabolic and renal function parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women > 18 years old at screening. Women of childbearing potential will be required to use two approved birth control methods during the entire course of the study.
    2. Known type 2 diabetes (T2D) or newly diagnosed T2D according to the 1997 American Diabetes Association diagnostic criteria*
    *Fasting plasma glucose (FPG) values ≥126 mg/dl, or symptomatic hyperglycemia and a casual glucose ≥200 mg/dl OR 2-h plasma glucose ≥200 mg/dl after a 75 g oral glucose load
    Diabetes may be managed with diet alone, or with any approved glucose-lowering therapies except for those listed in exclusion criteria 11 and 12. The diabetes reatment will follow the local usual standard of care
    3. HbA1C ≥6.5% and ≤10% at screening
    4. Body mass index (BMI) ≥ 23 kg/m2 at screening
    5. Subjects with established cardiovascular (CV) disease with onset ≥1 month prior to screening and who are stable in the Investigator’s judgment, based on the presence of at least one of the following:

    Documented coronary disease:
    • Myocardial infarction
    • History of coronary revascularization (percutaneous coronary interventions, coronary artery bypass graft surgery - CABG)
    • Documented angina pectoris with ischemic ECG changes at rest or with ischemic ECG changes on a graded exercise test, or positive cardiac imaging stress test results documenting ischemia
    • Angiographic or CT-imaging (e.g. MDCT/CTA) evidence of ≥ 70% narrowing of one coronary artery or ≥ 50% narrowing of two or more coronary arteries

    Documented cerebrovascular disease:
    • History of stroke (TIA is not fulfilling this inclusion criterion)
    • Angiographic evidence of at least 75% narrowing of one or more carotid arteries
    • History of arterial revascularization Documented symptomatic peripheral arterial disease:
    • Current intermittent claudication and ankle-brachial index ≤0.85 and/or documented peripheral artery disease
    • History of intermittent claudication and previous intervention (peripheral bypass, angioplasty)

    6. Ability and willingness to give written informed consent and to comply with the requirements of the study.
    E.4Principal exclusion criteria
    1. Women who are currently pregnant, currently lactating, or intent to become pregnant during the study period.
    2. Diagnosis of or history of:
    a. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly and Cushing’s Syndrome
    b. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
    c. Severe hypoglycemia (defined as requiring third party assistance) within one month prior to screening
    3. Clinically significant gastrointestinal (GI) disease, judged likely to limit tolerability of taspoglutide, such as inflammatory bowel disease, celiac disease, diabetic
    gastroparesis, cholelithiasis
    4. History of bariatric surgery (e.g. gastric bypass or antrectomy), small or large bowel resection, or laparoscopic gastric banding, or intent to undergo any similar procedure during the study period
    5. History of chronic pancreatitis or acute pancreatitis.
    6. Family or personal history of medullary thyroid carcinoma.
    7. Currently scheduled for cardiac surgery or arterial revascularization (carotid, coronary or peripheral) procedures
    8. Current NYHA class IV heart failure or post-transplantation cardiomyopathy
    9. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years
    10. Any concurrent medical condition/disorder that, in the opinion of the Investigator, is likely to:
    - Interfere with the subject’s ability to complete the entire study period or to participate in all aspects of the trial
    - Require the administration during the study of a treatment that would affect the interpretation of the efficacy and safety variables
    11. Current treatment or known intolerance to exenatide or exendin-4 analogues, GLP-1 or GLP-1 analogues
    12. Current treatment with insulin or insulin analogues
    13. Treatment with systemic (oral or parenteral) corticosteroids for more than 7 consecutive days within 12 weeks prior to screening
    14. Use of any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening unless local health authority guidelines mandate a longer period
    15. Any of the following laboratory abnormalities at screening:
    a. ALT or AST > 3 times the upper limit of the normal range
    b. Fasting triglycerides > 5.6 mmol/L (> 500 mg/dL)
    16. Glomerular filtration rate (GFR) <30 mL/min/1.73m2 estimated by the Modification of Diet in Renal Disease (MDRD) equation: GFR (mL/min/1.73 m2) = 186 x
    (serumcr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African-American) (Please see the following web-based GFR calculator: http://www.nkdep.nih.gov/professionals/gfr_calculators/orig_con.htm)
    17. Systolic blood pressure (SBP) ≥ 180 or diastolic blood pressure (DBP) ≥ 110 mmHg at screening
    18. Potentially unreliable subjects and those judged by the Investigator to be unsuitable for the study
    19. History of active substance abuse (including alcohol) within the past 2 years
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the time to first occurrence of any component of a cardiovascular composite endpoint (CV death, MI, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or hospitalization for heart failure) adjudicated by an independent cardiovascular event adjudication committee
    (CV-EAC). For this primary cardiovascular endpoint a noninferiority test will be applied to the data from the intent-to-treat (ITT) population to confirm the hypothesis that the hazard ratio comparing the taspoglutide and placebo groups falls below and excludes a 1.80 upper bound of the 95% confidence interval.
    Therefore, if the upper limit of the 95% CI of the HR is less than 1.80, non-inferiority will be concluded. If this initial objective is met the trial may be adapted, using existing statistical methods, with increases in the sample size and study duration in order to exclude, in sequence, a 30% increase in cardiovascular events (i.e. the upper 95% CI being less than a HR = 1.3) followed by (if met) an assessment of superiority.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Analysis of the primary composite cardiovascular outcome
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA124
    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
    The end of the clinical trial is defined as the date when the requisite number of
    cardiovascular events positively adjudicated for the primary endpoint has occurred and all subjects have completed a minimum of 6 months of treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 877
    F.4.2.2In the whole clinical trial 2000
    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)
    Please see Protocol, Section 3.2.3.
    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 Decision2009-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
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