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    Summary
    EudraCT Number:2007-000538-37
    Sponsor's Protocol Code Number:CLAF237ADE02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-000538-37
    A.3Full title of the trial
    A multicenter, randomized, double-blind, parallel-group study to investigate the glucose lowering effect, safety and tolerability of a 24 week treatment with Vildagliptin 100 mg o.a.d. versus placebo followed by a 12 week treatment period with open-label Vildagliptin 100 mg o.a.d. as add-on therapy in patients with type 2 diabetes inadequately controlled with Metformin monotherapy
    A.4.1Sponsor's protocol code numberCLAF237ADE02
    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 GmbH
    B.1.3.4CountryGermany
    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 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVildagliptin
    D.3.9.1CAS number 274901-16-5
    D.3.9.2Current sponsor codeLAF237
    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 II diabetes mellitus inadequate control
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the efficacy of vildagliptin 100 mg add-on therapy in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that the HbA1c reduction with vildagliptin 100 mg o.a.d. (hierarchically testing of pooled data of a.m. and p.m. dose as well as within a.m. and p.m. dosing groups) is superior to that with placebo after 24 weeks of treatment.
    E.2.2Secondary objectives of the trial
    1. To confirm the efficacy of add-on therapy with vildagliptin in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that the FPG reduction with vildagliptin 100 mg o.a.d. (pooled data of a.m. and p.m dose as well as within a.m. and p.m. dosing groups) is superior to that with placebo after 24 weeks of treatment.
    2. To confirm the safety of vildagliptin in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by showing that add-on therapy with vildagliptin 100 mg o.a.d. (pooled data of a.m and p.m. dosing) has comparable AE profiles including gastrointestinal (GI) tolerability and hypoglycemia to placebo during 24 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male, non-fertile female or female of childbearing potential using a medically approved birth control method.
    2. Patients with T2DM who have received metformin for at least three months prior visit 1 and have been on a stable (maximal tolerated) dose for a minimum of 8 weeks prior to visit 1.
    3. Agreement to maintain the same dose of metformin throughout the study.
    4. Age in the range of 18-85 years inclusive.
    5. HbA1c in the range of 6.5 – 8.0 % (inclusive) at visit 1.
    6. Agreement to maintain prior diet and exercise habits during the full course of the study.
    7. Ability to comply with all study requirements and signed informed consent to participate in the study.
    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 or gastroparesis.
    3. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical conditions that may interfere with the interpretation of efficacy and safety data during the study.
    4. A history of:
    • Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
    • any of the following within the past 6 months: myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a 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; percutaneous coronary intervention, unstable angina; or stroke.
    5. Congestive heart failure requiring pharmacologic treatment.
    6. Any of the following ECG abnormalities:
    • second degree AV block (Mobitz 1 and 2)
    • third degree AV block
    • prolonged QTc (> 500 ms)
    7. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
    8. Body mass index (BMI) outside 22- 40 kg/ m2 at visit 1
    9. Liver disease such as cirrhosis or chronic active hepatitis.
    10. Significant renal dysfunction (see also exclusion criteria 20 laboratory abnormalities).
    11. Donation of one unit (500 mL) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
    12. Contraindications and warnings according to the country specific label for metformin not listed in the other exclusion criteria.
    13. Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
    14. Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months.
    15. Treatment with growth hormone or similar drugs.
    16. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
    17. Treatment with class Ia, Ib and Ic or III anti-arrhythmics.
    18. 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.
    19. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e. cytostatic drugs).
    20. Any of the following significant laboratory abnormalities:
    • ALT, AST greater than 3 times the upper limit of the normal range at visit 1.
    • Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1.
    • Serum creatinine levels ≥ 1.5 mg/dL (132 mol/L) males, ≥ 1.4 mg/dL (123 mol/L) females, or a history of abnormal creatinine clearance at visit 1.
    • Clinically significant TSH values outside of normal range at visit 1.
    • Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1.
    21. History of substance abuse (including alcohol) within the past 2 years and potentially unreliable patients.
    22. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
    23. Women
    o who are pregnant or breast feeding (pregnancy 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))
    o who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for these women is required with sufficient lead time before inclusion
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is change from baseline in HbA1c at Week 24 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 (LOCF) approach).
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    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
    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 months9
    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 months9
    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 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-04-04. Yes
    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 state400
    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 Decision2007-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-07
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