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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2010-018708-99
    Sponsor's Protocol Code Number:1245.39
    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:2010-12-16
    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 number2010-018708-99
    A.3Full title of the trial
    An open-label, phase II study to determine acute (after the first dose administration) and chronic (after 28 days of treatment) effects of the sodium-glucose co-transporter-2 (SGLT-2) inhibitor empagliflozin (BI 10773) (25 mg once daily) on pre and postprandial glucose homeostasis in patients with IGT, type 2 diabetes mellitus and healthy subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine acute (after first dose) and chronic (after 28 days) effect oft he SGLT-2 inhibitor BI 10773 on pre and postprandial glucose homeostasis in patients with impaired glucose tolerance and type 2 diabetes mellitus
    A.4.1Sponsor's protocol code number1245.39
    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 SponsorBoehringer Ingelheim Pharma GmbH & Co. KG
    B.1.3.4CountryGermany
    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 organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 nameBI 10773
    D.3.2Product code BI 10773
    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.3.9.2Current sponsor codeBI 10773
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with IGT, type 2 diabetes mellitus and healthy subjects
    E.1.1.1Medical condition in easily understood language
    patients with IGT (impaired glucose tolerance) and type 2 diabetes mellitus and healthy subjects
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10018429
    E.1.2Term Glucose tolerance impaired
    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 assess the acute and chronic effects of empagliflozin (BI 10773) on fasting and postprandial
    glucose homeostasis in patients with IGT and type 2 diabetes mellitus and asses the acute effects of empagliflozin in healthy subjects. This includes the analysis of gut and pancreatic hormones, endogenous glucose production, beta cell function and urinary glucose excretion
    E.2.2Secondary objectives of the trial
    Secondary and further endpoints:
    • Change in rate of endogenous glucose production, urinary glucose excretion, gut and pancreatic hormonal control of glucose metabolism, beta cell function, insulin sensitivity, lipolysis, energy expenditure, weight and waist circumference and systolic and diastolic blood pressure after one dose, and after 28 days of treatment, change in fasting and postprandial plasma trigycerides, total and HDL cholesterol and plasma metabolites and change from baseline in HbA1c after 28 days of treatment.
    Endpoint(s) of safety
    Adverse events, hypoglycaemic events, protocol-specified significant adverse events, cardiovascular events and changes from baseline in clinical laboratory values
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for patients (IGT and T2DM):
    1a Male and female patients diagnosed with IGT according to the current ADA
    guidelines as a two-hour glucose levels of 140 to 199 mg/dl (7.8 mmol/l to 11.1
    mmol/l) on the 75-g oral glucose tolerance test, with an OGTT performed at the time
    of the screening visit (Visit 1), or
    1b Male and female patients diagnosed with type 2 diabetes mellitus prior to informed consent, on diet and exercise regimen who are drug-naïve, defined as absence of any antihyperglycemic therapy for 12 weeks prior to the planned Day 1 of the trial, or,
    1c Male and female patients diagnosed with type 2 diabetes mellitus prior to informed consent, who are pre-treated with metformin (only immediate release formulations permitted) background therapy, on a stable dose of metformin of at least 1500 mg per day, unchanged for at least 12 weeks prior to the planned Day 1 in the trial.
    2 HbA1c at Visit 1 (screening):
    a. For patients diagnosed of IGT: HbA1c < 6.5%
    b. For patients diagnosed of T2DM: HbA1c ≥ 6.5 % and ≤ 10.5 %
    3 Age ≥ 18 at Visit 1.
    4 BMI ≥ 20 and ≤ 40 Kg/m2 (Body Mass Index) at Visit 1.
    5 For patients who are under current antihypertensive treatment, this must be stable
    (with no changes in dosage) within 4 weeks prior to the planned Day 1 (Visit 4) in the trial.
    6 Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

    Inclusion citeria for healthy subjects:
    1 Males or females matching the below mentioned criteria and otherwise healthy accordign to the investigator's assessment, as based on the folowing criteria: a complete medical history including a physical examination, vital signs (BP, PR) and clinical laboratory tests.
    2 HbA1c at visit 1 (screening): <6.5%
    3 Confrimed normal glucose toelrance (NGT) by OGTT
    4 Age ≥ 45 and ≤ 55 at Visit 1.
    5 BMI ≥ 30 and ≤ 40 Kg/m2 (Body Mass Index) at Visit 1.
    6 Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.
    E.4Principal exclusion criteria
    1. Acute coronary syndrome (non-STEMI, STEMI, unstable AP), stroke or TIA within 6 months prior to informed consent.
    2. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
    3. Any other antidiabetic drug within 12 weeks prior to starting the open-label active
    treatment (Visit 4) except those defined as background via inclusion criterion 1c.
    4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST
    (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as
    determined during screening and/or run-in phase.
    5. Impaired renal function, defined as eGFR < 60 ml/min (moderate and severe renal
    impairment) as determined during screening and/or run-in phase.
    6. Medical history of insufficient bladder emptying (i.e. neurogenic bladder disorders).
    7. Patients with Hb values outside of normal reference ranges measured at central laboratory during screening and/or run-in phase.
    8. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
    9. Medical history of cancer (except for basal cell carcinoma) and/or treatment for
    cancer within the last 5 years.
    10. For patients on metformin background therapy, the investigator must check for
    potential exclusion criteria according to local metformin label.
    11. Treatment with anti-obesity drugs 3 months prior to
    informed consent or any other treatment at the time of screening (i.e. surgery,
    aggressive diet regimen, etc.) leading to unstable body weight.
    12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other
    uncontrolled endocrine disorder except T2DM. However, the use of inhaled steroids
    (e.g., for asthma, COPD) is not an exclusion as these do not cause systemic steroid
    action.
    13. Alcohol or drug abuse (according to investigators judgment) within the 3 months prior to informed consent that would interfere with trial participation or any ongoing
    condition leading to a decreased compliance to study procedures or study drug intake.
    14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial.
    15. Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who:
    • Are nursing or pregnant or
    • Are of child-bearing potential and are not practicing an acceptable method of
    birth control, or do not plan to continue using this method throughout the
    study and do not agree to submit to periodic pregnancy testing during
    participation in the trial. Acceptable methods of birth control include tubal
    ligation, transdermal patch, intra uterine devices/systems (IUD/IUSs), oral,
    implantable or injectable contraceptives, sexual abstinence (if acceptable by
    local authorities), double barrier method and vasectomised partner.
    16. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint in this study are the fasting plasma glucose (FPG) and the change in glucose metabolism (fasting pre-meal and postprandial glucose) from baseline to the first administration of the study medication (all subjects) and after 28 days of treatment (IGT and T2DM patients).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to the first administration of the study medication, and to 28 days of treatment. The term 'baseline' refers to the last observation prior to the inclusion into the open-label active-treatment period.
    E.5.2Secondary end point(s)
    Change in rate of endogenous glucose production from baseline after one dose, and after 28 days of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to the first administration of the study medication, and to 28 days of treatment. The term 'baseline' refers to the last observation prior to the inclusion into the open-label active-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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 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
    It has been provided in the protocol (section 3.3.4)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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 Decision2011-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-08
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