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    Summary
    EudraCT Number:2010-020684-20
    Sponsor's Protocol Code Number:CLAF237A23135
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-020684-20
    A.3Full title of the trial
    A 24-week, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of vildagliptin 50mg bid as an add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus
    A.4.1Sponsor's protocol code numberCLAF237A23135
    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 SponsorNovartis Pharma Services AG
    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 Yes
    D.2.1.1.1Trade name Galvus
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.1Product nameVildagliptin
    D.3.2Product code LAF237A
    D.3.4Pharmaceutical form 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.3.10 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 placeboTablet
    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 II Diabetes Mellitus
    MedDRA Classification
    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 vildagliptin 50 mg bid add-on therapy, as compared to placebo, to reduce HbA1c after 24 weeks treatment in patients with T2DM treated with stable doses of basal long-acting, intermediate-acting or pre-mixed insulin, with or without concomitant metformin therapy.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of vildagliptin 50 mg bid add-on therapy, as compared to placebo, to reduce HbA1c after 24 weeks of treatment in the subpopulation of patients with T2DM treated with insulin and metformin.
    • To assess the efficacy of vildagliptin 50 mg bid add-on therapy, as compared to placebo, to reduce HbA1c after 24 weeks of treatment in the subpopulation of patients with T2DM treated with insulin without metformin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Confirmed diagnosis of T2DM by standard criteria.
    2. Treatment with stable, once or twice daily doses (maximum dose of 1 unit/kg/day) of basal long-acting, intermediate-acting insulin alone or in pre-mixed combination with rapid-acting or short-acting insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks.
    3. Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1.
    4. HbA1c ≥7.5 to ≤11% at Visit 1
    5. Age: ≥18 to ≤80 years old at Visit 1
    6. BMI ≥22 to ≤40 kg/m2 at Visit 1.
    7. Males or females
    8. Females must be non-fertile or females of childbearing potential must use a medically approved birth control method based on local regulations
    9. Agreement to maintain a stable dose of insulin and metformin, if applicable, throughout the study.
    10. Agreement to continue current diet and exercise regime throughout the duration of the study, unless otherwise instructed by the investigator.
    11. Ability to comply with all study requirements.
    12. Written informed consent must be obtained before any assessment is performed
    E.4Principal exclusion criteria
    1. FPG ≥270 mg/dl (15 mmol/L) at Visit 1
    2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
    3. Use of any of the following medications as assessed at Visit 1:
    a. rapid or short acting insulin except in pre-mixed formulations with intermediate or long-acting insulin; insulin administration more frequently than twice-daily, or total insulin dose >1 unit/kg/day for the past 12 weeks
    b. Use of weight control products including weight-loss medications
    c. DPP-4 inhibitors, GLP-1 analogues/mimetics, Oral Anti-diabetic Agents (OADs) except metformin within the previous 6 months
    d. Chronic oral (>7 consecutive days), parenteral or intra-articular corticosteroid treatment within 8 weeks
    e. Treatment with growth hormone within the previous 6 months
    f. Treatment with any drug of known and frequent toxicity to a major organ, or that may interfere with the interpretation of the efficacy and safety data during the study.
    4. A history or evidence of any of the following:
    a. Acute metabolic conditions such an ketoacidosis, lactic acidosis or hyperosmolar state (including coma) within the past 6 months.
    b. Current diagnosis of congestive heart failure (NYHA III or IV).
    c. Myocardial infarction (MI) within the past 6 months
    d. Coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months
    e. Stroke or transient ischemic attack (TIA) within the past 6 months
    f. Unstable angina within the past 3 months
    g. Sustained and clinically relevant ventricular arrhythmia
    h. Active substance abuse including alcohol (> 3 drinks per day on average and/or binge drinking of more than 5 drinks in 1 day during the last 6 months) and alcohol related history of disease within the past 2 years.
    i. Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing’s syndrome or acromegaly-associated diabetes).
    j. Malignancy of an organ system (other than localized basal cell carcinoma of the skin) treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
    k. Hepatic disorder defined as:
    i. acute or chronic liver disease, evidence of hepatitis, cirrhosis or portal hypertension
    ii. history of imaging abnormalities that suggest liver disease (except hepatic steatosis), such as portal hypertension, capsule scalloping, cirrhosis
    l. acute infections which may affect blood glucose conrtol within the past 4 weeks
    5. Any of the following significant laboratory abnormalities as assessed at Visit 1:
    a. Clinically significant TSH outside of the normal range
    b. Clinically significant renal dysfunction as indicated by serum creatinine levels at Visit 1:
    i. for patients receving metformin ≥ 1.5 mg/dL (132 μmol/L) for males and ≥ 1.4 mg/dL (123 μmol/L) for females;
    ii. for other patients: abnormal creatinine clearance or evidence of renal impairment as determined by eGFR <30 ml/min/1.73m2 (MDRD)
    c. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1, confirmed by repeat measure within 3 working days
    d. Total bilirubin > 2 xULN and/or direct bilirubin > 1 x ULN confirmed by repeat measure within 3 working days
    e. Positive Hepatitis B surface antigen (HbsAg)
    f. Positive Hepatitis C antibody test (anti-HCV)
    g. Elevated fasting triglycerides > 500 mg/dl, confirmed by a repeat measure within 3 working days
    h. Clinically significant laboratory abnormalities which, in the opinion of the investigator, cause the patient to be considered inappropriate for inclusion in the study
    6. Any of the following ECG abnormalities at Visit 1:
    a. Second or third degree AV block without a pacemaker
    b. Long QT syndrome or QTc > 500 ms
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c
    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 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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.1.3Elderly (>=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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 213
    F.4.2.2In the whole clinical trial 428
    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 Decision2010-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-24
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