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    Summary
    EudraCT Number:2007-001049-16
    Sponsor's Protocol Code Number:CLAF237AGB01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-001049-16
    A.3Full title of the trial
    A multi-centre, randomised, double blind, parallel group study to investigate the efficacy and tolerability of treatment (24 weeks double blind phase followed by open-label extension) with either vildagliptin ( Galvus) or placebo combined with metformin in achieving optimal glycaemic control in older patients with type 2 diabetes.
    A.4.1Sponsor's protocol code numberCLAF237AGB01
    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 Pharmaceuticals UK Ltd
    B.1.3.4CountryUnited Kingdom
    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 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.3.8INN - Proposed INNVildagliptin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    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 demonstrate superior HbA1c control rates (where control is defined as HbA1c= or <6.5%) after 24 weeks treatment in subjects given vildagliptin added to metformin compared to those given placebo added to metformin for the ITT population.
    E.2.2Secondary objectives of the trial
    To demonstrate superior HbA1c response rates where response is defined as
    i) HbA1c= or <7.0% (for the subgroup with baseline HbA1c > 7.0%) and
    ii) HbA1c =or < 7.5% (for the subgroup with baseline HbA1c > 7.5%

    To investigate whether there is a comparable lipid profile
    To investigate whether there are comparable overall adverse event, particularly hypoglycaemic episodes and discotinuation rates.
    To investigate differeces in GI symptoms, as defined by the Gastrointestinal Symptoms Reporting scale.
    To compare changes in FPG (fasting plasma glucose)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or Female; (65 to 80 years old); patients with T2DM (diagnosed at least 3 months prior to visit 1) who have received metformin 500mg BD- 2000mg daily divided dose of metformin monotherapy for at least three months immediately prior to visit 1
    body mass index of 20-45.0kg/m2 inclusive at visit 1
    HbA1c from 6.6 - 8.0% inclusive at visit 1.
    FPG,15mmol/L; written informed consent to participate in the study .
    Male or non-fertile female
    A non fertile female is defined as: post menopausal ( 12 months of natual (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40mIU/m); 6 weeks post bilateral oophorectomy with or without hysterctomy;or sterilised by tubal ligation.
    E.4Principal exclusion criteria
    1. A history of:
    • type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly.
    • acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
    2. Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy, gastroparesis, as well as symptoms of worsening hyperglycaemia (i.e. polyuria, polydipsia, weight loss) in the absence of any intercurrent illness or other incidental circumstances potentially causing deterioration of glucose control.
    3. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
    4. Any of the following within the past 6 months:
    • myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with an old MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor);
    • coronary artery bypass surgery or percutaneous coronary intervention;
    • unstable angina that is not pharmacologically controlled or stroke.
    • TIA in the last 6 months
    5. Congestive heart failure (CHF) requiring pharmacological treatment other than loop diurectics, digoxin, ARB or any beta blocker.
    6. Any of the following ECG abnormalities:
    • Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation
    • second degree AV block (Mobitz 1 and 2)
    • third degree AV block
    • prolonged QTc (> 500 msec)
    8. Malignancy including leukaemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
    9. Liver disease such as cirrhosis or chronic active hepatitis.
    10. Contraindications and warnings according to the UK label for metformin not listed in the other exclusion criteria.
    • If eGFR < 45ml/min as calculated by the MDRD formula then the patient should be excluded from the study
    11. Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months.
    12. Treatment with other oral antidiabetics within 3 months prior to visit 1.
    13. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
    14. Treatment with growth hormone or similar drugs.
    15. Treatment with class Ia, Ib and Ic or III anti-arrhythmics.
    16. Use of other investigational drugs at visit 1, or within 30 days or 5 half-lives of visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
    17. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e., cytostatic drugs).
    18. Any of the following significant laboratory abnormalities:
    • ALT, AST greater than 2 times the upper limit of the normal range at visit 1, confirmed by a repeat test within 3 working days.
    • Total bilirubin greater than 2 times the upper limit of the normal range at visit 1 and direct bilirubin greater than the upper limit of normal range at visit 1, confirmed by a repeated measure within 3 working days.
    Hepatitis B or C positive (on blood test)
    • Clinically significant renal dysfunction as indicated by MDRD eGFR < 45ml/min.
    • Clinically significant TSH values outside of normal range at visit 1.
    • Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycaemia, hyperinsulinaemia, and glycosuria at visit 1.
    • Fasting triglycerides  700 mg/dL (7.9 mmol/L) at visit 1.
    19. History of active substance abuse (including alcohol) within the past 2 years.
    20. Participation in previous vildagliptin studies.
    21. In addition, the following may exclude a patient from this study:
    • Known sensitivity to study drug(s) or class of study drug(s)
    • Patients with any other severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
    • Use of any other investigational agent in the last 30 days
    E.5 End points
    E.5.1Primary end point(s)
    Hba1C control rate (where control is defined as HbA1C=< 6.5% after 24 weeks treatment (or at the final visit with HbA1c measurement for those patients who do not have a Week 24 HbA1c measurement- the last observation carried forward approach) in subjects given vildagliptin added to metformin compared to those given placebo combined with metformin for the overall ITT population.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    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 Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned50
    E.8.5The trial involves multiple Member States No
    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 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
    LPLV
    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 months6
    E.8.9.1In the Member State concerned days
    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) 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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state438
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 438
    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 Decision2007-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-27
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