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    Summary
    EudraCT Number:2006-004407-19
    Sponsor's Protocol Code Number:BC20688
    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:2006-12-02
    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 number2006-004407-19
    A.3Full title of the trial
    A multi-center, double-blind, randomized, placebocontrolled, dose-ranging phase 2 study to investigate pharmacodynamics, safety, tolerability and pharmacokinetics of RO5073031 in patients with type 2 diabetes mellitus treated with a stable dose of metformin (BC20688)
    A.4.1Sponsor's protocol code numberBC20688
    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 nameGLP-1
    D.3.2Product code RO5073031 10% (w/w) sustained release formulation
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 275371-94-3
    D.3.9.2Current sponsor codeRO5073031
    D.3.9.3Other descriptive name[Aib8,35]hGLP-1(7-36)NH2, acetate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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 8.1
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.2Term 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 efficacy, with respect to glycemic control, of multiple doses and regimens of RO5073031 which, when added to metformin, are safe and tolerable compared with placebo in patients with type 2 diabetes.
    E.2.2Secondary objectives of the trial
    -To compare the effects of RO5073031 with placebo, when both are added to metformin, on body weight and additional parameters of glycemic and lipid control;
    -To investigate, by a population analysis approach, the pharmacokinetics and the exposure-response relationship of RO5073031 in the target population, including the influence of covariates.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Type 2 diabetes mellitus patients treated with individual maximum tolerated daily dose of metformin monotherapy (metformin daily dose ≥ 1.5 g, maximum not higher than recommended in the label) for at least 3 months prior to screening.
    -Males, postmenopausal women (defined as more than two years after the cessation of menses) or surgically sterilized women.
    -Age 18 to 75 years at the time of the screening examination.
    -HbA1c ≥ 7.0 % and ≤ 9.5 % at screening.
    -Fasting plasma glucose (FPG) > 126 mg/dL (7.0 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at screening.
    -BMI > 25 kg/m2 and ≤ 45 kg/m2 at screening
    -Stable weight ± 10% for at least 3 months before screening.
    -Patients able and willing to give written informed consent and to comply with the requirements of the study (patients that cannot follow blood glucose selfmonitoring and study requirements independently from another person cannot be included).
    E.4Principal exclusion criteria
    -Type 1 diabetes mellitus patients
    -Known hypersensitivity to RO5073031 or any of its components.
    -Known contraindications to metformin, i.e.
    -Congestive heart failure requiring pharmacologic treatment;
    -Clinically significant respiratory insufficiency.
    -History of ketoacidosis or lactic acidosis.
    -Treatment with any anti-hyperglycemic medication other than metformin monotherapy during the last 3 months (except insulin use in acute situations or
    during surgery for up to 7 days).
    -Any previous exposure to GLP-1, GLP-1 analogues or exenatide before the study.
    -Systemic use of corticosteroids in the last 3 months.
    -Use of weight lowering medications (orlistat, sibutramine, rimonabant, phentermine) in the last 3 months.
    -Patients receiving ACE inhibitors, beta-blockers, thiazide diuretics, thyroid hormones, and/or lipid lowering medications who are not on a stable dose for
    more than 6 weeks prior to the start of the study.
    -Impaired liver function (ALAT or ASAT or total bilirubin or alkaline phosphatase > 2.5x ULN) at screening.
    -Renal disease or renal dysfunction (as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dl [females]) at screening.
    -Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg, despite treatment) at the time of the screening examination.
    -Myocardial infarction or stroke within 6 months prior to the screening examination.
    -Known hemoglobinopathy.
    -Known proliferative diabetic retinopathy.
    -Clinically significant GI disease including inflammatory bowel disease, irritable bowel
    syndrome, celiac disease, dyspepsia, apparent diabetic gastroparesis, diabetic diarrhoea, or surgery of the gastro-intestinal tract (except appendectomy / cholecystectomy).
    -Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the investigator.
    -Pregnant or lactating women or women of childbearing potential.
    -Participation in an investigational drug study within 90 days [3 months] (or treatment with any investigational agent within five half-lives of that investigational drug, whichever is longer) prior to screening.
    -Serious illness, such as active cancer, major active infection, severe psychiatric disorders at the time of the screening examination.
    -Alcohol or drug abuse.
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY / PHARMACODYNAMIC: Absolute change from baseline in HbA1c at 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 Yes
    E.6.10Pharmacogenetic Yes
    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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 264
    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 Decision2006-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-09-06
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