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    Summary
    EudraCT Number:2007-005931-27
    Sponsor's Protocol Code Number:D1690C00005
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-26
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2007-005931-27
    A.3Full title of the trial
    A 24-Week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Glimepiride (a Sulphonylurea) in Subjects with Type 2 Diabetes who Have Inadequate Glycaemic Control on Glimepiride Therapy Alone
    A.4.1Sponsor's protocol code numberD1690C00005
    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.3.8INN - Proposed INNDapagliflozin
    D.3.9.2Current sponsor codeBMS-512148
    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.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 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 INNdapagliflozin
    D.3.9.2Current sponsor codeBMS-512148
    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 Information not present in EudraCT
    D.IMP: 3
    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.3.8INN - Proposed INNdapagliflozin
    D.3.9.2Current sponsor codeBMS-512148
    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
    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 LLT
    E.1.2Classification code 10029505
    E.1.2Term Non-insulin-dependent 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
    To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycaemic control in subjects with type 2 diabetes, as determined by the change in A1C levels from baseline to Week 24.
    E.2.2Secondary objectives of the trial
    Key secondary objectives
    − To show that dapagliflozin plus glimepiride results in greater reductions in body
    weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.
    − To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h
    post-challenge plasma glucose level as a response to an oral glucose tolerance test
    (OGTT) from baseline to Week 24.
    − To show that dapagliflozin plus glimepiride results in a larger proportion of subjects
    achieving an A1C < 7% after 24 weeks of treatment compared to placebo plus glimepiride.
    − To show that dapagliflozin plus glimepiride results in greater reductions in body
    weight or less weight gain in subjects with baseline BMI ≥ 27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.
    − To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of a written informed consent
    2. Males and females ¡Ý 18 years of age at time of consenting
    3. Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study and for up to 4 weeks after
    the study in such manner that the risk of pregnancy is minimized.
    4. Diagnosed with Type 2 diabetes
    5. Subjects on a stable sulphonylurea monotherapy dose that is at least half the
    maximal recommended dose for a minimum of 8 weeks duration prior to the
    enrolment visit.

    N.B. Subjects on glimepiride dose higher than 4 mg/day are not eligible for the
    study.

    Inclusion criteria before lead-in period (Visit 2, laboratory values from Visit 1):
    6. Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%
    7. FPG ≤ 15 mmol/L (≤ 270 mg/dL)
    8. C-peptide ≥ 1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L)

    Inclusion criteria at randomization (Visit 5, laboratory values from Visit 4 or Visit 1 for patients who skipped the lead-in period):
    9. A1C ≥ 7% and ≤ 10%
    10. FPG ≤ 15 mmol/L (≤ 270 mg/dL)
    11. C-peptide ≥ 1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L
    E.4Principal exclusion criteria
    1. Type 1 diabetes, diabetes insipidus, corticosteroid-induced type 2 diabetes, and
    history of diabetic ketoacidosis or hyperosmolar non-ketonic coma
    2. Symptoms of poorly controlled diabetes that would preclude participation in this
    trial including but not limited to marked polyuria and polydipsia with greater than
    10% weight loss during the three months prior to enrolment, or other signs and
    symptoms
    3. Use of glimepiride dose higher than 4 mg/day at enrolment and 8 weeks prior to the enrolment
    4. AST > 3 x ULN
    5. ALT > 3 x ULN
    6. Serum total bilirubin > 34 ╬╝mol/L (> 2.0 mg/dL)
    7. Calculated Creatinine-Clearance < 50 ml/min (calculated by Cockcroft-Gault
    formula) or a measured serum creatinine value of > 177 µmol/L (2mg/dL)
    8. Urine albumin:creatinine ratio (UACR) > 1,800 mg/g (> 203.4 mg/mmol)
    9. Creatine kinase (CK) > 3 x ULN
    10. Haemoglobin ≤ 100 g/L (≤ 10.0 g/dL) for men; haemoglobin ≤ 95 g/L (≤ 9.5 g/dL) for women
    11. Severe uncontrolled hypertension defined as systolic BP ≥ 180 mm Hg and/or
    diastolic BP ≥ 110 mm Hg
    N.B. If subject’s BP is higher than recommended target for BP control the
    antihypertensive therapy should be optimised according to the local standards
    of care.
    12. Thyroid-stimulating hormone (TSH) values outside normal range, to be further
    confirmed by abnormal free T4 values. Subjects with abnormal free T4 values will
    be excluded.
    13. Significant cardiovascular history within the past 6 months prior to the enrolment
    visit (myocardial infarction, unstable angina, transient ischaemic attack (TIA),
    unstable or previously undiagnosed arrhythmia, unstable chronic heart failure,
    cardiac surgery or revascularization (CABG/PTCA))
    14. History of malignancy within the last 5 years, excluding successful treatment of
    basal or squamous cell skin carcinoma or in-situ carcinoma of the cervix
    15. History of blood lipid induced eruptive xanthomas or hypertriglyceridaemia
    induced pancreatitis
    16. History of unstable or rapidly progressing renal disease
    17. Known condition of congenital renal glycosuria
    18. History of chronic haemolytic anemia, with the exception of sickle cell trait (SA) or
    thalassemia minor.
    19. Subjects who, in the judgement of the Investigator, may be at risk for dehydration
    20. Pregnant or breastfeeding subjects
    21. Body mass index (BMI) > 45.0 kg/m2
    22. Suspicion that the patient is infected according to World Health Organisation
    (WHO) risk categories 2 to 4 (See Appendix C)
    23. Treatment with chronic insulin, within 24 weeks prior to Visit 1 (however, one
    temporary period of daily insulin injections no longer than 7 days is allowed)
    24. Replacement or chronic systemic treatment with corticosteroid, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to enrolment visit
    25. History of bariatric surgery.
    26. Administration of weight loss medication, including but not limited to sibutramine,
    phentermine, orlistat, rimonabant, benzphetamine, diethylpropion,
    methamphetamine, and/or phendimetrazine, within 30 days prior to enrolment
    27. Treatment for Human immunodeficiency virus (HIV)/use of antiviral drugs
    (delavirdine, indinavir, nelfinavir, ritonavir, saquinavir) and/or known
    immunocompromised status, including subjects who have undergone organ
    transplantation
    28. Known hypersensitivity to dapagliflozin or glimepiride. Intolerance to
    a sulphonylurea at any time in the past, or pre-existing medical conditions that is
    contraindicated for the use of a sulphonylurea
    29. History of drug-induced myopathy or drug-induced CK elevation
    30. Severe hepatic disease, including chronic active hepatitis. Positive serologic
    evidence of current infectious liver disease including subjects being positive for
    Hepatitis B viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus
    antibody
    31. History of drug-induced liver enzyme elevations
    32. History of alcohol or drug abuse within the last 5 years
    33. Any clinically significant abnormality or other serious or unstable medical or
    psychological condition identified in the subjects’ medical history, on physical
    examination or laboratory tests that, in the judgement of the investigator, would
    compromise the subjects’ safety or successful participation in the Clinical Study
    34. Involvement in the planning and conduct of the study (applies to AstraZeneca and Bristol-Myers Squibb staff or staff at the study site)
    35. Previous enrolment or randomisation of treatment in the present study
    36. Previous participation in a clinical trial with dapagliflozin (BMS-512148) and/or any other SGLT2 inhibitor
    37. Receiving any investigational product within 12 weeks prior to Visit 1
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is the change in A1C from baseline to the end of the 24-week double-blind treatment period.
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 325
    F.4.2.2In the whole clinical trial 545
    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 Decision2008-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-28
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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