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    Summary
    EudraCT Number:2009-017358-10
    Sponsor's Protocol Code Number:D1680C00003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-017358-10
    A.3Full title of the trial
    SAVOR Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes
    A.3.2Name or abbreviated title of the trial where available
    SAVOR
    A.4.1Sponsor's protocol code numberD1680C00003
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorASTRAZENECA
    B.1.3.4CountryItaly
    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 namesaxagliptin
    D.3.2Product code BMS-477118-11
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSAXAGLIPTIN
    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.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 namesaxagliptin
    D.3.2Product code BMS-477118-11
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSAXAGLIPTIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral 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 PT
    E.1.2Classification code 10049746
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objectives: Efficacy The primary efficacy objective is to determine, as a superiority assessment, whether treatment with saxagliptin compared with placebo when added to current background therapy will result in a reduction in the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke, in patients with type 2 diabetes mellitus. Safety The primary safety objective of this trial is to establish that the upper bound of the 2-sided 95% confidence interval for the estimated risk ratio comparing the incidence of the composite endpoint of cardiovascular death, non fatal myocardial infarction or non-fatal ischaemic stroke, in patients with type 2 diabetes mellitus, observed with saxagliptin to that observed in the placebo group is less than 1.3.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objective: The secondary efficacy objective is to determine whether treatment with saxagliptin compared with placebo when added to current background therapy in patients with type 2 diabetes mellitus will result in a reduction of the composite endpoint of cardiovascular death, non fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or hospitalisation for coronary revascularisation. Secondary safety objectives: Safety and tolerability will be evaluated by assessment of overall adverse events and adverse events of special interest. These will include assessment of the long-term effects of saxagliptin on decrease in lymphocyte counts, decrease in thrombocyte counts, severe infections, hypersensitivity reactions, liver abnormalities, bone fractures, pancreatitis, skin reactions and renal abnormalities.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    4.1 Inclusion criteria For inclusion in the study, patients should fulfil the following criteria: 1. Provision of informed consent prior to any study-specific procedures 2. Age ≥40 years 3. Diagnosed with T2DM based on the current American Diabetes Association guidelines 4. HbA1c ≥6.5% (based on the last measured and documented laboratory measurement in the previous 6 months) 5. High risk for a CV event defined as having either established CV disease and/or multiple risk factors: Established CV disease (see Appendix E): � Ischaemic heart disease, and/or � Peripheral vascular disease (eg, intermittent claudication), and/or � Ischaemic stroke Multiple Risk Factors Patient must be at least 55 years old (men) and 60 years old (females) and have at least one additional risk factor (treated or non-treated) from the following: � Dyslipidemia (based on the last measured and documented laboratory measurement in the previous 6 months and defined as at least 1 of the following): o High level of low-density lipoprotein cholesterol (LDL-C), defined as >130 mg/dL (> 3.36 mmol/L) o Low level of high-density lipoprotein cholesterol (HDL-C), defined as <40 mg/dL (<1.04 mmol/L) for men or <50 mg/dL (<1.30 mmol/L) for women � Hypertension, as confirmed at the enrolment visit o BP >140/90 mm/Hg or on a BP-lowering agent with BP >130/80 mm/Hg �Currently smoking, as confirmed at the enrolment visit 6.Women of childbearing potential (WOCBP) must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose. Men participating in the study should also take precautions not to father a child while participating in the study and for 4 weeks after intake of the last dose. WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of study medication. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥2 consecutive years). Inclusion criteria for the optional biological research The inclusion criteria for the optional biological research are provided in Appendix H. If a patient declines to participate in the biological research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study as described in this protocol, as long as consent to the main study has been obtained. Inclusion criteria for the optional genetic research The inclusion criteria for the optional genetic research are provided in Appendix F. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study as described in this protocol, as long as consent to the main study has been obtained. It is possible that a patient may be randomised into the main study before the genetic component has been approved by the institution s Institutional Review Board (IRB). If that patient elects to participate in the genetic portion of this study, after IRB approval is granted, he/she may do so. The genetic sample is not limited to collection at Visit 1 but may be collected at any visit, provided that written informed consent for collecting the sample has been obtained.
    E.4Principal exclusion criteria
    4.2 Exclusion criteria Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including non-CV disease (eg, active malignancy, cardiomyopathy, cirrhosis, or chronic lung disease) with a likely fatal outcome within 5 years 2. Current or previous (within 6 months) treatment with an incretin-based therapy such as DPP4 inhibitors and or GLP 1 mimetics 3. Acute vascular (cardiac or stroke) event <2 months prior to randomisation 4. Initiation of chronic dialysis and/or renal transplant and/or a serum creatinine >6.0 mg/dL 5. Pregnant or breast-feeding patients 6. History of human immunodeficiency virus 7. Patients being treated for severe auto immune diseases such as lupus 8. Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid 9. Patients with: � Body mass index >50 kg/m2 � Last measured HbA1c ≥12% � Sustained BP >180/100 mm Hg � LDL-C >250 mg/dL (> 6.48 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6 months) � Triglycerides >1000 mg/dL (>11.3 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6 months) � HDL-C <25 mg/dL (<0.64 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6 months) � Known liver function tests >3 times upper limit of normal (ULN), (based on the last measured and documented laboratory measurement in the previous 6 months) 10. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and BMS or representative staff and/or staff at the study site) 11. Previous randomisation in the present study 12. Participation in another clinical study with IP and/or intervention within 30 days prior to Visit 1 13. Individuals at risk for poor protocol or medication compliance For procedures for withdrawal of incorrectly randomised patients, see Section 5.3. Exclusion criteria for the optional genetic research The exclusion criteria for the optional genetic research are provided in Appendix F.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy and safety outcome variable of the study is defined as the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke (time to first event).
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA250
    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
    La fine dello studio e` stabilita` in funzione degli numero di eventi cardiovascolari con una durata prevista di 5 anni.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 state278
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4800
    F.4.2.2In the whole clinical trial 12000
    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 Decision2010-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-16
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