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    Summary
    EudraCT Number:2007-004833-40
    Sponsor's Protocol Code Number:EFC10518
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-09
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2007-004833-40
    A.3Full title of the trial
    A randomized, double blind, placebo controlled study evaluating the glycemic effect of rimonabant added to metformin in patients with type 2 diabetes insufficiently controlled with metformin monotherapy
    A.3.2Name or abbreviated title of the trial where available
    TOCCATA
    A.4.1Sponsor's protocol code numberEFC10518
    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 Sponsorsanofi-aventis recherche & developpement
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name ACOMPLIA
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNrimonabant
    D.3.9.1CAS number 168273-06-01
    D.3.9.2Current sponsor codeSR141716
    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 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
    Type 2 Diabetes patients insufficiently controlled with metformin monotherapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.1
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate the superiority of rimonabant 20 mg versus placebo when added daily to metformin 1500 mg/day (or more) on glycemic control (HbA1c) after 36 weeks treatment in patients with type 2 diabetes mellitus.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of rimonabant 20 mg added to metformin over a period of 36 weeks on:
    • Additional markers of glycemic control (eg, fasting plasma glucose, HOMA-IR, insulin)
    • Lipid profile (HDL-C, Triglycerides, LDL-C, total cholesterol, total cholesterol/HDL-C)
    • Body weight
    • Abdominal obesity (as measured by waist circumference)

    To evaluate the safety of rimonabant 20 mg added to metformin during the entire study period (47 weeks) including assessment of nerve conduction with nerve conduction studies at substudy sites, mood state/alertness (ie, visual analogue scale) and cognition (ie, digit symbol substitution test) at selected sites over the study treatment period.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Nerve conduction study, 14 January 2008, version 1
    Objectives: assessment of the effect of rimonabant on the diabetic microvascular complication of neuropathy.
    E.3Principal inclusion criteria
    1. Documented history of type 2 diabetes as defined by 2006 WHO criteria (fasting venous plasma glucose concentration ≥7.0 mmol/L (126 mg/dl) or 2-h post-glucose load venous plasma glucose ≥11.1 mmol/L (200 mg/dl)
    2. HbA1c between 7% to 10% (inclusive) at Screening Visit
    3. Treatment with metformin with a fixed and stable dose of 1500 mg/day or more, and no other anti-diabetic agent for at least the past 3 months prior to Screening Visit
    E.4Principal exclusion criteria
    • Exclusion criteria related to study methodology:
    1. Refusal or inability to give written informed consents to participate in the study
    2. Age <18 years old or below legal age of majority
    3. Change in lipid modifying agent including introduction, change in dose or cessation in the 3 months prior to Screening Visit
    4. Administration of long acting systemic corticosteroids of any duration or other systemic corticosteroids for more than 10 days in the previous 3 months from Screening Visit
    5. Use of any anti-obesity agent or drugs for weight loss (eg, sibutramine, orlistat, herbal preparations, phentermine, amphetamines) in the 3 months prior to Screening visit
    6. Weight loss of >5 kg within 3 months prior to Screening Visit
    7. C-peptide <1.0 ng/mL at Screening Visit
    8. Administration of other investigational drugs within 30 days or 5 half lives, whichever is longer, prior to Screening Visit
    9. Participation in a previous rimonabant study
    10. Prior exposure to CB1 antagonists including rimonabant
    11. Presence of any severe medical or psychological condition that, in the opinion of the Investigator, would compromise the patient’s safe participation including uncontrolled serious psychiatric illness such as major depression, suicidal ideation and medical history of suicide attempt.
    12. Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that the Investigator feels would restrict or limit the patient’s successful participation for the duration of the study
    13. Presence of any clinically significant endocrine disease (other than type 2 diabetes) according to the Investigator (patients on thyroid replacement therapy will be included if the dosage of thyroxine is stable for at least three months prior to Screening Visit)
    14. Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer
    15. Positive lab test for Hepatitis B surface antigen and/or Hepatitis C antibody at Screening Visit
    16. Inability to follow verbal and written instructions

    • Exclusion criteria related to metformin:
    17. Renal disease or renal dysfunction (eg, as suggested by serum creatinine levels ≥1.5 mg/dL or 132.6 umoles/L [males], ≥1.4 mg/dL or 123.76 umoles/L [females] or abnormal creatinine clearance) at Screening Visit
    18. Presence of congestive heart failure requiring pharmacologic treatment
    19. Known hypersensitivity to metformin hydrochloride
    20. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

    • Exclusion criteria related to rimonabant:
    21. Known hypersensitivity/intolerance to rimonabant or any of the excipients of rimonabant tablets such as lactose (such as history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption)
    22. Pregnant or breast-feeding women,
    23. Women of childbearing potential not protected by effective method of birth control and/or who are unwilling or unable to be tested for pregnancy
    24. History of severe hepatic impairment
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c at Week 36 from baseline
    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 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) 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 360
    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 Decision2008-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-17
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