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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-004042-42
    Sponsor's Protocol Code Number:DEER
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-07-14
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2013-004042-42
    A.3Full title of the trial
    A study to investigate the potential renoprotective role of sodium-glucose transporter-2 (SGLT-2) antagonist Dapagliflozin in Type 2 diabetic patients with diabetic nephropathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study aims to investigate the potential beneficial effects on the kidney of a new medication called Dapagliflozin in type 2 diabetic patients.
    A.3.2Name or abbreviated title of the trial where available
    Dapagliflozin in type 2 diabetic nephropathy (DEER)
    A.4.1Sponsor's protocol code numberDEER
    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 SponsorKing’s College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstra Zeneca UK Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Janaka Karalliedde
    B.5.3 Address:
    B.5.3.1Street AddressFanklin-Wilkin Building, King's College London - Waterloo Campus, 150 Stamford Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9NH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402078484464
    B.5.5Fax number004402074078786
    B.5.6E-mailj.karalliedde@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorGuy's and St Thomas NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstra Zeneca UK Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing’s College London
    B.5.2Functional name of contact pointDr Janaka Karalliedde
    B.5.3 Address:
    B.5.3.1Street Address3rd Floor, Fanklin-Wilkin Building , King's College London - Waterloo Campus, 150 Stamford Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9NH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402078484464
    B.5.5Fax number004402074078786
    B.5.6E-mailj.karalliedde@kcl.ac.uk
    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 Yes
    D.2.1.1.1Trade name Dapagliflozin
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameRamipril
    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 INNRAMIPRIL
    D.3.9.1CAS number 87333-19-5
    D.3.9.4EV Substance CodeSUB10248MIG
    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.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
    Diabetic Nephropathy
    E.1.1.1Medical condition in easily understood language
    Diabetic Renal Disease
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061835
    E.1.2Term Diabetic nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 study the potential protective role of Dapagliflozin on renal disease in patients with Type 2 diabetes and diabetic renal disease. We aim to evaluate in this trial if the combination of Dapagliflozin and Ramipril (an established reno-protective drug) significantly reduces microalbuminuria ( a markers of renal damage) as compared to Ramipril alone in patients with type-2 diabetes with preserved renal function and residual albuminuria despite currently available optimal treatments.
    E.2.2Secondary objectives of the trial
    Changes in the following will be measured -
    Central aortic blood pressure and central arterial stiffness;
    Brachial blood pressure;
    Plasma renin activity, aldosterone, ACE-2 and Angiotensin 1-7/1-9 levels;
    Total body water and extracellular fluid volumes by bio-impedance;
    Highly sensitive CRP;
    HbA1c, fasting c-peptide, glucose;
    Lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides);
    Serum electrolytes (sodium, magnesium, potassium), and renal function (serum creatinine, and estimated GFR;
    Plasma albumin and liver function tests (ALT, ALP GGT);
    Serum uric acid, serum calcium, serum phosphate, and haemoglobin;
    Renal tubular markers L-FABP levels and retinol binding protein;
    24 hr urine sodium, urine magnesium, urine uric acid, urine calcium, urine phosphate and urine potassium excretion;
    Vascular cell adhesion molecule-1, Von Willebrand factor, oxidized low density lipoprotein and endothelin-1;
    Quality of life (EQOL5)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients aged 35 to 75 years with known diagnosis of type-2 diabetes as per ADA criteria (1) with HbA1c ≥ 7% on monotherapy or combination therapy with approved hypoglycaemic agents (e.g. metformin, sulphonylurea, acarbose, or DPP IV inhibitor, insulin, GLP-1 receptor agonist)
    - Patients with residual albuminuria (defined as a urine albumin creatinine ratio (ACR) >3 mg/mmol in the preceding 12 months) on maximal tolerated dose of ACE-inhibitor or ARB

    - preserved renal function [estimated GFR >60 ml/min by 4 variable MDRD equation (23)]

    - Patients on a stable dose of ACE-inhibitors or ARB in the preceding 3 months.

    - Written informed consent to participate in the study prior to any study procedures;
    - Ability to communicate and comply with all study requirements.
    E.4Principal exclusion criteria
    - Patients with impaired renal function (eGFR<60 ml/min);
    - Patients with recent (6 months) history of cardiovascular or cerebrovascular disease event;
    - Patients on thiazolidinediones (e.g. Pioglitazone);
    - Patients who have started drugs which could affect sodium balance (e.g. diuretics, non steroidal anti-inflammatory drugs (NSAID), cyclo-oxygenase (Cox) 2 inhibitors, beta blockers or Calcium channel antagonists) within the previous month;
    - Patients with uncontrolled hypertension defined as systolic blood pressure and diastolic blood pressure greater than 160 and 100 mmHg respectively;
    - Pregnancy and lactating females
    - Pre-menopausal female patients not using contraception;
    - Patients with very poorly controlled diabetes defined as HbA1c >12%;
    - Patients with non diabetic renal disease;
    - Patients with a history of connective tissue disease or inflammatory arthritis;
    - Recent ( within 3 months) or current use of SGLT2 receptor blocker;
    - Patients not willing to use appropriate contraception;
    - Patients on loop diuretics
    - Recent history of (within 3 years of screening visit) or active malignancy
    - Patients with New York Heart Association class 3 or 4 cardiac disease
    - Abnormal Liver function tests defined as ALT or AST levels >3 times the upper limit of normal at screening
    - History of hereditary glucose-galactose malabsorption or primary renal glucosuria;
    - History of one or more severe hypoglycaemic episodes within 6 months of screening; (severe hypoglycaemic episodes is as defined by ADA criteria (24).
    - Previous hypersensitivity to the active substance or to any of the excipients
    - Patients with an insufficient understanding of the trial
    - Patients with a history of DKA or at high risk of DKA (T2DM patients with known low C-peptide (<0.25nmol/l), patients with a history of pancreatitis, patients with conditions that lead to restricted food intake or severe dehydration.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be change albuminuria measured by albumin excretion rate (AER); median of three non-consecutive independent urine collections performed within 10 days of 24 weeks' treatment with Dapagliflozin and Ramipril compared to Ramipril only
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after treatment with Dapagliflozin and Ramipril compared to Ramipril only.
    E.5.2Secondary end point(s)
    Changes in the following will be measured -
    Central aortic blood pressure and central arterial stiffness;
    Brachial blood pressure;
    Plasma renin activity, aldosterone, ACE-2 and Angiotensin 1-7/1-9 levels;
    Total body water and extracellular fluid volumes by bio-impedance;
    Highly sensitive CRP;
    HbA1c, fasting c-peptide, glucose;
    Lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides);
    Serum electrolytes (sodium, magnesium, potassium), and renal function (serum creatinine, and estimated GFR;
    Plasma albumin and liver function tests (ALT, ALP GGT);
    Serum uric acid, serum calcium, serum phosphate, and haemoglobin;
    Renal tubular markers L-FABP levels and retinol binding protein, soluble Klotho
    24 hr urine sodium, urine magnesium, urine uric acid, urine calcium, urine phosphate and urine potassium excretion;
    Vascular cell adhesion molecule-1, Von Willebrand factor, oxidized low density lipoprotein and endothelin-1;
    Quality of life (EQOL5)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks after treatment with Dapagliflozin and Ramipril compared to Ramipril only.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 0
    F.4.2.2In the whole clinical trial 0
    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)
    No arrangements have been made for continued provision of the study medication after the trial has completed.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-18
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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