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    Summary
    EudraCT Number:2014-001102-17
    Sponsor's Protocol Code Number:CV181363
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-30
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-001102-17
    A.3Full title of the trial
    A 26-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 26-week Long -term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in Combination with Metformin Compared to Sitagliptin in Combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    26-week Long -term Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in Combination with Metformin Compared to Sitagliptin in Combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone.
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberCV181363
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02284893
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number001800236993
    B.5.6E-mailinformation.center@astrazeneca.com
    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 No
    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.3.9.1CAS number 361442-04-8
    D.3.9.2Current sponsor codeBMS-477118-11
    D.3.9.3Other descriptive nameSAXAGLIPTIN
    D.3.9.4EV Substance CodeSUB25220
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 nameDapagliflozin
    D.3.2Product code BMS-512148
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNDAPAGLIFLOZIN
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeBMS-512148
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB31650
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 3
    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 Januvia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    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 nameSitagliptin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNSITAGLIPTIN
    D.3.9.1CAS number 654671-77-9
    D.3.9.3Other descriptive nameSITAGLIPTIN PHOSPHATE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB25198
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    E.1.1.1Medical condition in easily understood language
    Patients with documented Type 2 Diabetes Mellitus treated with metformin with inadequate glycemic control.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the mean change from baseline in glycated hemoglobin (HbA1c) achieved with saxagliptin in co administration with dapagliflozin added to current background therapy with metformin compared to sitagliptin added to current background therapy with metformin at week 26.
    E.2.2Secondary objectives of the trial
    • To compare the proportion of patients achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, of double-blind treatment with saxagliptin in co-administration with dapagliflozin added to current background therapy with metformin compared to sitagliptin added to current background therapy with metformin at week 26.
    • To compare the mean change from baseline in total body weight achieved with saxagliptin in co administration with dapagliflozin added to current background therapy with metformin compared to sitagliptin added to current background therapy with metformin at week 26.
    • To assess the mean change from baseline in Fasting Plasma Glucose (FPG) achieved with saxagliptin in co administration with dapagliflozin added to current background therapy with metformin compared to sitagliptin added to current background therapy with metformin at week 26.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Written Informed Consent
    a) Subjects (or designee) must be willing and able to give signed and dated written informed consent.
    2. Target Population
    a) Patients with T2DM with inadequate glycemic control, defined as a central laboratory HbA1c ≥ 8.0% and ≤ 10.5 % obtained at the screening visit.
    i) Note: At Week -2 (Lead-In), a qualification check will be performed and subjects will be inclusive if their FPG is ≤ 270 mg/dl (15 mmol/L). A re-test will be permitted within 7 days if the initial result was > 270mg/dl but < 300mg/dl (16.7 mmol/L). Subjects will be excluded if the mean value of the Week -2 (Lead-In) result and the re-test result is > 270mg/dl.
    b) Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening.
    c) BMI > 20.0 kg/m2 at the enrollment visit.
    3. Inclusion criteria at randomization (visit 3, based on laboratory results from visit 2): a) FPG ≤ 270 mg/dL (≤ 15 mmol/L).
    4. Age and Reproductive Status
    a) Males and Females, age ≥ 18 years old at time of screening visit.
    b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
    c) Women must not be breastfeeding.
    d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: Saxagliptin, Dapagliflozin and Sitagliptin (30 days) plus 30 days (duration of ovulatory cycle) for a total of 60 days post-treatment completion.
    e) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: Saxagliptin, Dapagliflozin and Sitagliptin plus 5 half-lives of the study drug (30 days) plus 90 days (duration of sperm turnover) for a total of 120 days post-treatment completion.
    f) Azoospermic males and WOCBP who are not continuously heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in protocol.
    E.4Principal exclusion criteria
    1.Target Disease Exceptions
    a) Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus.
    b) History of diabetic ketoacidosis
    2. Medical History and Concurrent Diseases
    a) Any of the following CV/Vascular Diseases within 3 months of the enrollment visit: Myocardial infarction, cardiac surgery or revascularization, unstable angina, unstable congestive heart failure, transient ischemic attack or significant cerebrovascular disease, unstable or previously uniagnosed arrhythmia, congestive heart failure or unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%.
    b) Renal Disease: History of unstable or rapidly progressing renal disease, impairment of renal function, history of unexplained microscopic or gross hematuria, or microscopic hematuria at screening, confirmed by a follow-up sample at next scheduled visit, where according to the investigator a satisfactory evaluation of hematuria has not been conducted based on guidance in Section 5.3.2. Not applicable as per Protocol Amendment Number 1, hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization. If bladder cancer is identified, subjects are not eligible to participate.
    c) Hepatic/GI Diseases: severe hepatic insufficiency and/or significant abnormal liver function, serum total bilirubin (TB) > 2 mg/dL (> 34.2 ╬╝mol/L) at the time of screening, history of, or current, acute pancreatitis, severe hepatic disease, including chronic active hepatitis. Positive serologic evidence of current infectious liver disease, including patient's positive for Hepatitis B viral antibody IgM, Hepatitis B surface antigen, and Hepatitis C virus antibody
    d) Hematological and Oncological Disease/Conditions: History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis, history of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
    3.Physical and Laboratory Test Findings at the time of screening
    a) Hemoglobin ≤110 g/L for men; hemoglobin ≤ 100 g/L for women
    b) Abnormal Free T4
    c) Any clinically significant abnormality identified on physical examination, ECG or laboratory tests, which in the judgment of the investigator would compromise the patient’s safety or successful participation in the study
    4. Other Exclusion Criteria
    a) Subjects who have contraindications to therapy as outlined in the saxagliptin and dapagliflozin Investigator Brochure, the local saxagliptin or dapagliflozin package insert or the local metformin package insert, or the local sitagliptin package insert, including current treatment with potent cytochrome P450 3A4/5 inhibitors
    b) Prisoners or subjects who are involuntarily incarcerated
    c) Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
    d) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program
    e) History of bariatric surgery or lap-band procedure within 6 months prior to screening
    f) Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit ( Topical, nasal, or inhaled corticosteroids are allowed)
    g) Any unstable endocrine, psychiatric or rheumatic disorders as judged by the Investigator
    h) Volume-depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics, should carefully monitor their volume status
    i) Subject with any condition which, in the judgment of the Investigator, may render the subject unable to complete the study or which may pose a significant risk to the subject or subject suspected or with confirmed poor protocol or medication compliance
    j) Subject is currently abusing alcohol or other drugs or has done so within the last 6 months prior to the screening visit
    k) Subject is a participating investigator, study coordinator, employee of an investigator or immediate family member of any of the aforementioned.
    l) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/BMS staff and/or staff at the study site)
    m) Previous enrollment or randomization in the present study
    n) Administration of any other investigational drug within 30 days of the screening visit
    o) Clinical conditions or clinically significant abnormalities, in any laboratory value(s) collected after screening and prior to randomization which, in the Investigator’s judgment, should preclude entry into the treatment period
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for analysis is change from baseline to week 26 in HbA1c.
    A repeated measures analysis (using a MIXED model) will be used to analyze the change from baseline in HbA1c at Week 26. The model will contain terms for treatment group, baseline measurement, time (each relevant visit), the interaction of treatment and time, and the interaction of baseline value and time. Descriptive statistics as well as adjusted means and 95% confidence intervals will be calculated for the change from baseline in HbA1c as well as for the difference between treatment groups.
    The primary endpoint analysis will be repeated using all available values including those after rescue/intensification and also using all available data and including a time varying covariate which indicates rescue status.
    The comparator (sitagliptin) will be tested against saxagliptin/dapagliflozin for the primary endpoint at the alpha = 0.05 level (two-sided). The secondary endpoints (described below) will then be tested sequentially. Each comparison will be tested at the alpha = 0.05 (two-sided) level.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoints will be evaluated on specified visits per schedule of assessments.
    E.5.2Secondary end point(s)
    Secondary endpoints for analysis include:
    1) Percent of subjects achieving a therapeutic glycemic response (HbA1c < 7 %) at Week 26
    2) Mean change from baseline in total body weight at Week 26
    3) Mean change from baseline in Fasting Plasma Glucose (FPG) at Week 26
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints will be evaluated on specified visits per schedule of assessments.
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hungary
    Mexico
    Poland
    Romania
    South Africa
    United States
    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
    At the end of the study period (Week 52), the sponsor will not continue to supply study drug (saxagliptin or dapagliflozin) to subjects/investigators unless the sponsor chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    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 months7
    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 months7
    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.1.2.1Number of subjects for this age range: 336
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state133
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 420
    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)
    At the end of the study period (Week 52), the sponsor will not continue to supply study drug (saxagliptin or dapagliflozin) to subjects/investigators unless the sponsor chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    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 Decision2015-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-26
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