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    Summary
    EudraCT Number:2007-000634-39
    Sponsor's Protocol Code Number:808040006
    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:2009-03-27
    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 number2007-000634-39
    A.3Full title of the trial
    Postpartum Intervention in Women with Gestational Diabetes using Insulin
    A.3.2Name or abbreviated title of the trial where available
    PINGUIN
    A.4.1Sponsor's protocol code number808040006
    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 SponsorForschergruppe Diabetes e. V. am Helmholtz Zentrum München
    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.3.2Product 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.3.9.2Current sponsor code808040006
    D.3.9.3Other descriptive nameVildagliptin
    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 Yes
    D.3.11.13.1Other medicinal product typechemically synthesized
    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
    women with a recent history of gestational diabetes which required insulin therapy up to 7 months post-partum
    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 determine the efficacy of 24 month Vildagliptin treatment to reduce the progression to type 2 diabetes in islet autoantibody negative women with recent insulin treated GDM.
    E.2.2Secondary objectives of the trial
    To determine the mechanism of action of Vildagliptin treatment by testing the hypothesis that Vildagliptin 100 mg qd improves beta cell function and insulin sensitivity.
    To determine the durability of clinical benefit of 24 month Vildagliptin 100 mg qd treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female subjects who are at least 18 years of age, who are less than 7
    months post-partum, and who had insulin treated GDM during their most
    recent pregnancy (see 8)
    2. Written informed consent to participate in the study
    3. Ability to comply with all study requirements
    4. Agree with the medication after finishing with breast feeding
    5. Contraception after the last pregnancy for the next 2 years
    E.4Principal exclusion criteria
    1. Pregnant or lactating female
    2. GAD antibody or IA-2 antibody positive
    3. Diabetes, defined as any of the following (FPG > 126mg/dL (7.0 mmol/L) at visit 1 or 2-hr post-challenge plasma glucose (after a 75-g OGTT) > 200 mg/dL (11.1 mmol/L) or diabetes diagnosed by a physician and confirmed by other clinical data, other than gestational diabetes
    4. Use of insulin or any oral antidiabetic agents after pregnancy and prior to visit 1
    5. concomitant use of drugs that affect carbohydrate metabolism
    6. psychiatric disorders
    7. history of vein thrombosis
    8. bleeding disorders by clinical history
    9. severe maternal or fetal complications during pregnancy
    10. dietary only treatment during pregnancy
    11. family planning within the next two years
    12. 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 ms)
    13. malignancy including leukemia and lymphoma within the last 5 years
    14. liver disease such as cirrhosis or chronic active hepatitis
    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. any significant laboratory abnormalities at visit 1
    19. Any of the following significant laboratory abnormalities
    • ALT, AST > 2 times the upper limit of the normal range (ULN) at visit 1, confirmed by a repeat measure within 3 working days
    • Total bilirubin > 2 times ULN and direct bilirubin > ULN at visit 1, confirmed by a repeat measure within 3 working days
    20. Participation in another clinical trial within the last 3 months
    21. Blood loss (e.g. by blood donation) of > 400 ml within the last 2 months
    22. Any disease or condition which could impair study participation in the opinion of the
    investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point will be diabetes diagnosed on the basis of a six-monthly oral glucose tolerance test according to the 1997 criteria of the American Diabetes Association: a value of plasma glucose above 140 mg/dl in the fasting state or 200 mg/dl two hours after a 75 g oral glucose load. Diagnosis will require confirmation by a second test within 6 weeks. If the diagnosis is not confirmed by the second test, the subject will continue treatment to the original random assignment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 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
    see the protocol 6.5.5. Study drug discontinuation
    Manifestation of diabetes, defined as any of the following (FPG > 126 mg/dL (7.0 mml/L) or 2-hr post-challenge plasma glucose (after a 75g-OGTT) > 200 mg/dL (11.1 mmol/L) or diabetes diagnosed by a physician and confirmed by other clinical data.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    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 months0
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 2009-03-27. 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 state140
    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 Decision2007-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-03
    P. End of Trial
    P.End of Trial StatusOngoing
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