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    Summary
    EudraCT Number:2008-001249-24
    Sponsor's Protocol Code Number:BC21587
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-06
    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 ConcernedLatvia - SAM
    A.2EudraCT number2008-001249-24
    A.3Full title of the trial
    A multi-center, double-blind, randomized, parallel group, placebo-controlled 12-week study to investigate glycemic parameters of efficacy, safety/ tolerability and pharmacokinetics of five dose levels of RO4998452 in patients with type 2 diabetes mellitus
    A.4.1Sponsor's protocol code numberBC21587
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 nameSGLT2 co-transporter inhibitor
    D.3.2Product code RO4998452
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSGLT2 co-transporter inhibitor
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeRO4998452/F02
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSGLT2 co-transporter inhibitor
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeRO4998452/F03
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSGLT2 co-transporter inhibitor
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeRO4998452/F04
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeselective inhibitor of the sodium glucose co-transporter 2 (SGLT2)
    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 placeboCapsule, hard
    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 10045242
    E.1.2Term Type II 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 determine the absolute change in HbA1c concentration from baseline to the end of the treatment period compared to placebo
    E.2.2Secondary objectives of the trial
    To determine additional efficacy parameters, safety and tolerability following RO4998452 administration compared to placebo, including
    • the absolute change in fasting plasma glucose from baseline to the end of the treatment period
    • the glycemic response with additional parameters of glycemic control (such as mean daily blood glucose obtained from 7-point plasma glucose profile, fructosamine, Meal Tolerance Test)
    • the tolerability and safety profile
    • the effects on body weight
    • the pharmacokinetics and the exposure-response relationship of RO4998452 including the influence of covariates (by a population analysis approach)

    Exploratory objectives:
    • to determine the effects on feeling of hunger and thirst
    • to determine the dose-response curve of RO4998452 on 24-h urinary glucose
    excretion
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Roche Sample Repository Research Project in association with protocol BC21587

    Protocol number/Version: BC21587RG/A (dated 13 October 2008)

    Objective for substudy BC21587RG:
    • To obtain a single blood sample from consenting patient enrolled in associated study BC21587 for pharmacogenetic and genetic research analysis
    E.3Principal inclusion criteria
    • Patients with type 2 diabetes, diagnosed for at least 3 months at screening
    examination, based on WHO criteria
    • Patients who are either
    (1) treated with diet and exercise and a stable dose of metformin (daily dose 1.5 g
    to 3.0 g but not higher than recommended in the locally approved label) for at
    least 3 months or
    (2) treated with diet and exercise
    • HbA1c equal to or greater than 7.0 % and equal to or less than 10.0 % at
    screening and at the visit preceding randomization
    • Age 18 to 75 years (inclusive) at the time of screening
    • BMI > 22 kg/m2 and equal to or less than 45 kg/m2 at screening
    • Able and willing to give written informed consent and able to comply independently
    to all study requirements
    E.4Principal exclusion criteria
    • Type 1 diabetes mellitus patients
    • History of ketoacidosis or lactic acidosis
    • Fasting serum C-peptide equal to or less than 1 ng/ml at screening for patients
    with a BMI equal to or less than 25 kg/m2
    • Fasting plasma glucose > 240 mg/dl (13.3 mmol/l)
    • Any contraindication to metformin as indicated in the label such as congestive
    heart failure (NYHA class III or IV or requiring pharmacological treatment) or
    respiratory failure
    • History of body weight changes within 3 months prior to screening > 10% of body
    weight measured at screening
    • Patients currently or within 12 months prior screening treated with insulin (with
    the exception of emergency situations in which insulin was given for < 7
    consecutive days)
    • Patients currently or within 2 months prior to screening treated with any oral or
    injectable anti-diabetic agent except stable dose of metformin
    • Patients currently or within 6 months prior to screening treated with any PPARĪ³
    agonist
    • History of antidiabetic triple therapy
    • Patients currently or within 3 months prior to screening treated with any
    prescription weight-lowering medication or orlistat
    • Patients treated with lipoprotein modifying therapy (e.g. niacin, statin) if dosage or
    dosing regimen was changed within 4 weeks prior to screening. Dosage and
    dosing regimen for fibrates need to be stable for 3 months prior to screening.
    • Patients receiving antihypertensive medication, and/or thyroid hormones if the
    dose(s) has (have) not been stable for at least 4 weeks prior to randomization
    • Systemic, inhaled or topical corticosteroid therapy for > 14 treatment days within 3
    months prior to screening
    • Impaired liver function (as suggested by ALT, AST, total bilirubin or alkaline
    phosphatase > 2.5x ULN) at screening
    • Hyponatremia (< 120 mM) or hypernatremia (> 150 mM) at screening or within 3
    months prior to screening
    • Renal disease or renal dysfunction (as suggested by serum creatinine levels equal
    to or greater than 1.5 mg/dl (133 µmol/l) [males], equal to or greater than 1.4
    mg/dl (124 µmol/l) [females]) at screening
    • Personal or family history of renal glucosuria (= glucosuria in the absence of
    diabetes mellitus)
    • History of bariatric surgery or small bowel resection
    • History of uncontrolled hypertension (SBP > 150 mmHg and/or DBP > 95 mmHg,
    despite treatment) < 3 months prior to screening
    • Myocardial infarction or stroke within 6 months prior to screening
    • Evidence of significant pre-diagnosed diabetic complication requiring medical
    treatment (e.g., medically treated gastroparesis, diagnosed proliferative diabetic
    retinopathy)
    • Any known serious illness (such as cancer, major active infection, severe
    psychiatric disorders, clinical significant gastrointestinal disorder, active
    autoimmune disease, chronic inflammatory condition, chronic anemia, all
    hemoglobino¬pathies) at screening which could interfere with the conduct of the
    study
    • Any new conditions diagnosed at screening requiring treatment longer than 10
    days or chronic therapies that can not be stabilized during the screening period
    • Any abnormalities in clinical laboratory tests or ECG (e.g., clinically relevant QTc
    prolongation, family history of long QT syndrome, concomitant use of class I
    antiarrythmic drugs such as disopyramide, quinidine, procainamide, mexiletine,
    flecainide, propafenone) which precludes safe involvement in the study as judged
    by the investigator
    • Participation in an investigational drug study within 2 months (or five half-lives,
    whichever is longer) prior to screening
    • Pregnant or lactating women, positive pregnancy test, and women of childbearing
    potential not using two adequate methods of contraception, including a barrier
    method
    • History of alcohol or drug abuse
    • Known hypersensitivity to RO4998452 or any of the components of its formulation
    • Persons with albinism
    E.5 End points
    E.5.1Primary end point(s)
    • Absolute change in HbA1c from baseline to the end of the 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    biomarker research
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 EEA22
    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 in the trial (LPLV).
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 300
    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)
    There are no plans for treatment or medical supervision of the patients after the end of the trial. It will be left at the discretion of the Investigator to continue the original metformin monotherapy, or to initiate a monotherapy or combination therapy, after completion of the treatment period. The physician in charge of the patient should closely monitor glycemia levels during the transition period.
    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 Decision2008-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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