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    Summary
    EudraCT Number:2010-022658-18
    Sponsor's Protocol Code Number:CLAF237A23150
    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:2010-12-03
    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 number2010-022658-18
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin in type 2 diabetes mellitus patients ≥ 70 years (drug-naive or inadequately controlled on oral agents).
    A.4.1Sponsor's protocol code numberCLAF237A23150
    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 Ltd
    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 LAF237
    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.3.11 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 2 diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study will be declared positive if at least one of the two hypotheses is significant:
    1. to evaluate the efficacy of vildagliptin as initial or add-on therapy in elderly patients with T2DM who are drug-naive or inadequately controlled with oral anti-diabetic agents (OADs) by testing the hypothesis that the HbA1c reduction with vildagliptin is superior to that of placebo after 24 weeks of treatment.
    2. to evaluate the proportion of elderly patients with T2DM who are drug-naive or inadequately controlled with OADs by testing the hypothesis that the proportion of patients reaching their investigator-defined individual target HbA1c while being treated with vildagliptin is superior to that of placebo after 24 weeks of treatment
    E.2.2Secondary objectives of the trial
    •to evaluate the safety and tolerability of vildagliptin as initial or add-on therapy in elderly patients with T2DM who are drug-naive or inadequately controlled with OADs during 24 weeks.
    •to evaluate the efficacy of vildagliptin as initial or add-on therapy in elderly patients with T2DM who are drug-naive or inadequately controlled with OAD by testing the hypothesis that the FPG reduction with vildagliptin is superior to that of placebo after 24 weeks of treatment.
    •to assess the responder rates of vildagliptin, as compared to placebo, in elderly patients with T2DM who are drug-naive or inadequately controlled with OADs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •age: ≥ 70 years inclusive at Visit 1.
    •female or male.
    •patients with a confirmed diagnosis of T2DM: i/treated with a stable dose of OADs for at least 12 weeks prior to Visit 1. OADs that are allowed in this study are metformin, sulfonylurea (SU), thiazolidinediones (TZDs), α-glucosidase inhibitors or meglitinides, used either as monotherapy or in combination. ii/drug-naive patients diagnosed at least 12 weeks prior to Visit 1 (drug-naive is defined as no treatment with OADs for at least 12 weeks prior to Visit 1 and no treatment with OADs for > 3 consecutive months at any time in the past).
    • HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled.
    • body mass index (BMI) in the range of 19-45 kg/m2 inclusive at Visit 1.
    • agreement to maintain a stable background medication dose throughout the study, if currently receiving OADs.
    E.4Principal exclusion criteria
    • FPG ≥270mg/dL (15mmol/L) at Visit 1.
    • use of any of the following medications as assessed at Visit 1:
    - prior use of insulin treatment (for ≥ 7 consecutive days) in the preceding 12 weeks.
    - use of DPP-4 inhibitors or GLP-1 analogues in the preceding 12 weeks.
    - use of weight control products including weight-loss medications in the last 12 weeks.
    - use of oral (≥7 consecutive days) or chronic parenteral or intra-articular corticosteroid treatment within the last 8 weeks.
    - treatment with growth hormone within the previous 6 months.
    - 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.
    • a history or evidence of any of the following:
    - acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including coma) within the past 6 months.
    - current diagnosis of congestive heart failure (NYHA III or IV).
    - myocardial infarction within the past 6 months.
    - coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months.
    - Stroke, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months.
    - unstable angina within the past 3 months.
    - sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled).
    - type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing’s syndrome or acromegaly-associated diabetes).
    - 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.
    - hepatic disorder defined as:
    - acute or chronic liver disease, evidence of hepatitis, cirrhosis or portal hypertension.
    - history of imaging abnormalities that suggest liver disease (except hepatic steatosis), such as portal hypertension, capsule scalloping, cirrhosis.
    - acute infections which may affect blood glucose control within the past 4 weeks.
    •any of the following significant laboratory abnormalities as assessed at Visit 1
    - clinically significant elevation or reduction of thyroid stimulating hormone (TSH) outside of the normal range.
    - clinically significant renal dysfunction: glomerular filtration rate (GFR) <30mL/min/1.73m2 (via modification of diet in renal disease (MDRD) formula).
    - 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.
    - total bilirubin > 2 x ULN and/or direct bilirubin > 1 x ULN confirmed by repeat measure within 3 working days.
    - positive Hepatitis B surface antigen (HBsAg).
    - positive Hepatitis C virus (HCV) antibody test (anti-HCV).
    - elevated fasting triglycerides (TGs) > 500mg/dL (5.65mmol/L).
    • any of the following electrocardiographic abnormalities at Visit 1
    - second or third degree atrio-ventricular block without a pacemaker.
    - long QT syndrome or QTc > 500ms.
    •history of hypersensitivity to DPP-4 inhibitors.
    E.5 End points
    E.5.1Primary end point(s)
    • HbA1c reduction.
    • percentage of patients reaching individual HbA1c target at week 24 or end of study.
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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) No
    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 Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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 Decision2011-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-14
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