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    Summary
    EudraCT Number:2009-012806-37
    Sponsor's Protocol Code Number:D1690C00010
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-012806-37
    A.3Full title of the trial
    A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study with a 24-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg Daily in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on a DPP-4 inhibitor (Sitagliptin) Alone or in Combination with Metformin
    A.4.1Sponsor's protocol code numberD1690C00010
    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 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 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 nameDapagliflozin
    D.3.2Product code BMS-512148
    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.3.9.2Current sponsor codeBMS-512148-05
    D.3.9.3Other descriptive namedapagliflozin
    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.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
    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 12.0
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    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 change from baseline in haemoglobin A1c at 24 weeks between dapagliflozin 10 mg and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.
    E.2.2Secondary objectives of the trial
    To assess effect on: total body weight – fasting plasma glucose – 2-hour post liquid meal glucose – blood pressure − glycaemic control – lipid metabolism; To assess, in a sub-population, the effect on: seated systolic blood pressure – haemoglobin A1c; To evaluate the safety and tolerability by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycaemic events, calculated creatinine clearance, estimated glomerular filtration rate and physical examination findings over 24 weeks of treatment; To collect and store DNA for future exploratory genetic research studies; Objectives of the 24-week extension period: − to assess the maintenance of efficacy of dapagliflozin versus placebo over 48 weeks of treatment − to assess the safety and tolerability of dapagliflozin over 48 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures 2. Diagnosis of type 2 diabetes 3. Men or women age ≥18 years old (for patients taking metformin, the upper age limit should be based on local metformin label restrictions) 4. Current antihyperglycaemic treatment: − Drug naïve (defined as no antihyperglycaemic therapy for at least 10 weeks prior to enrolment), or − Ongoing treatment with sitagliptin monotherapy 100 mg QD for at least 10 weeks prior to enrolment, or − Ongoing treatment with vildagliptin monotherapy 50 mg BID for at least 10 weeks prior to enrolment, or − Ongoing treatment with metformin IR or XR monotherapy ≥1500 mg/day for at least 10 weeks prior to enrolment, or − Ongoing treatment with metformin IR or XR ≥1500 mg/day plus sitagliptin 100 mg/day for at least 10 weeks prior to enrolment, or − Ongoing treatment with metformin IR or XR ≥1500 mg/day plus vildagliptin 50 mg BID for at least 10 weeks prior to enrolment. 5. HbA1c: At enrolment (Visit 1) − ≥7.2% and ≤10.0% for patients entering the study on sitagliptin100 mg QD or vildagliptin 50 mg BID monotherapy, sitagliptin 100 mg QD plus metformin ≥1500 mg/day or vildagliptin 50 mg BID plus metformin ≥1500 mg/day − ≥7.7% and ≤10.5% for patients who are drug naïve or who are treated with metformin ≥1500 mg/day monotherapy 6. Women of childbearing potential who comply with defined criteria.
    E.4Principal exclusion criteria
    1. Diagnosis of Type 1 diabetes mellitus, known diagnosis of MODY or secondary diabetes mellitus 2. History of diabetic ketoacidosis; history of severe diabetic retinopathy or severe diabetic foot complications 3. Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment 4. FPG >270 mg/dL (>15 mmol/L) 5. History of bariatric surgery 6. Diabetes insipidus 7. Thyroid-stimulating hormone (TSH) values outside normal range 8. Renal failure or renal dysfunction (Calculated Creatinine Clearance <50 mL/min calculated by Cockroft-Gault formula for patients not taking metformin, further specified for patients taking metformin; Urine albumin: creatinine ratio >1800 mg/g (>203.4 mg/mmol)) 9. Known condition of familial renal glucosuria 10. AST >3 xULN and/or ALT >3 x ULN, total bilirubin >2.0 mg/dL (>34.2 μmol/L) 11. Congestive heart failure NYHA class IV, unstable or acute congestive heart failure 12. Significant cardiovascular history within the past 3 months prior to the screening visit (myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization, cerebrovascular accident), unstable cardiovascular disease at enrolment as judged by investigator 13. Systolic BP ≥170 mmHg and/or diastolic BP ≥110 mmHg 14. Haemoglobin ≤10 g/dL (≤100 g/L) for men; haemoglobin ≤9.0 g/dL (≤90 g/L) for women 15. Creatinine Kinase >3X ULN, history of drug-induced myopathy or drug-induced CK elevation 16. Use of: antihyperglycaemic medications other than DPP-4 inhibitors or metformin during the 10 weeks prior to enrolment, insulin within 24 weeks of enrolment (with exceptions), weight loss medication (including but not limited to sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylproprion, methamphetamine, and/or phendimetrazine) within 30 days prior to enrolment, glucocorticoids equivalent to oral prednisolone ≥10 mg (betametasone ≥1.2 mg, dexamethasone ≥1.5 mg, hydrocortisone ≥40 mg) per day within 30 days prior to enrolment, unstable doses of teriparatide, bisphosphonates and/or calcitonin, antiviral drugs 17. Patients at risk of dehydration 18. Acute or chronic metabolic acidosis.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variable: Change in haemoglobin A1c from baseline to week 24
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    The end of the trial is defined as 'the last visit of the last patient undergoing the 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 months0
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 281
    F.4.2.2In the whole clinical trial 810
    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)
    Patients will be followed for 3 weeks after discontinuing investigational product. During this
    time patients can be treated as necessary without any further protocol restrictions.
    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 Decision2009-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-26
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