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    Summary
    EudraCT Number:2007-003370-26
    Sponsor's Protocol Code Number:CLAF237ADE03
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-06-18
    Trial 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 number2007-003370-26
    A.3Full title of the trial
    A prospective, single center, double blind, placebo controlled study of adipocytokines, adipose tissue gene expression and hepatic insulin clearance in the therapeutic response to vildagliptin in man
    A.4.1Sponsor's protocol code numberCLAF237ADE03
    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 SponsorCharite Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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.3.4Pharmaceutical 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 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
    This is a single center, randomized, double-blind pilot study on patients with Type 2 diabetes. The purpose of this study is to test the effects of vildagliptin (as add-on to metformin) on hepatic insulin clearance, on levels of adipocytokines, metabolic syndrome biomarkers and adipose tissue mRNA expression.
    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
    The primary objective of this study is to examine the effects of vildagliptin 50mg twice daily used in combination with metformin in patients with type 2 diabetes on the change of Adiponectin level.
    E.2.2Secondary objectives of the trial
    The changes in hepatic insulin clearance after 12 weeks of treatment will be examined. The changes in the levels of circulating HMW adiponectin and inflammatory and metabolic synrome biomarkers such as CRP, IL1ß and MCP1 will be measured. Furthermore adipose tissue mRNA expression of GIP induced genes including adiponectin receptors and GIP receptors will be studied. GIP regulated genes have been recently identified by our group after infusion of GIP. The most prominently genes will be treated as GIP marker genes.
    The efficacy of vildagliptin 50 mg twice daily used in combination with metformin to improve glycemic control will be demonstrated by measurement of HbA1c and fasting plasma glucose.
    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 (Pearl Index < 1).
    • A non-fertile female is defined as: post menopausal (12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation.
    • A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
    • Medically approved birth control method (Pearl index<1) include: hormonal contraceptives, IUD, and double-barrier contraception. Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Reliable contraception should be maintained throughout the study.
    2. Age in the range of 18-78 years inclusive.
    3. Patients with T2DM who have taken metformin prior to visit 1.
    4. Diagnosis of T2DM for at least 4 weeks prior to study entry (Visit 1).
    5. HbA1c <9% inclusive at visit 1.
    6. Written informed consent to participate in the study.
    7. Ability to comply with all study requirements.
    E.4Principal exclusion criteria
    1. Pregnant or lactating female or female of childbearing potential without a medically approved birth control method (Pearl Index < 1).
    2. 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.
    3. Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
    4. 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.
    5. 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 or percutaneous coronary intervention;
    • unstable angina or stroke.
    6. Congestive heart failure (CHF) requiring pharmacological treatment.
    7. 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 leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
    9. Liver disease such as cirrhosis or chronic active hepatitis.
    10. Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 month.
    11. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
    12. Treatment with growth hormone or similar drugs.
    13. Treatment with class Ia, Ib and Ic or III anti-arrhythmics.
    14. Use of other investigational drugs at visit 1, or within 60 days prior to visit 1.
    15. Treatment with cytostatic drugs within the past 3 months.
    16. History of active substance abuse (including alcohol) within the past 2 years.
    17. Any of the following significant laboratory abnormalities:
    • ALT, AST greater 2 times the upper limit of the normal range (ULN) at visit 1, confirmed by a repeat measure within 3 working days.
    • Total bilirubin greater than 2 times ULN and direct bilirubin greater the upper limit of the normal range at visit 1, confirmed by a repeat measure within 3 working days.
    • At any time during the clinical trial, if ALT and/or AST is greater than or equal to 3 times the ULN without clinical symptoms, the tests must be repeated within 3 days. If confirmed the patient must be discontinued.
    • At any time during the clinical trial, if ALT and/or AST is greater than or equal to 3 times the ULN, with total bilirubin elevated above the ULN, then the patient must be discontinued immediately
    • Clinically significant renal dysfunction as indicated by 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.
    • 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 1A.
    • Fasting triglycerides  700 mg/dL (7.9 mmol/L) at visit 1.
    18. Lack cooperativeness with pseudonymized storing and passing on of pseudonymized data in accordance to the trial protocol.
    19. Involuntary commitment in accordance with AMG §40 (1) 4).
    E.5 End points
    E.5.1Primary end point(s)
    change in Adiponectin level
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 Yes
    E.7.1.3.1Other trial type description
    prospective, double blind, placebo controlled pilot study of vildagliptin effects
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    provided in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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) 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 state40
    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 Decision2007-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-02
    P. End of Trial
    P.End of Trial StatusOngoing
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