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    Summary
    EudraCT Number:2008-001663-11
    Sponsor's Protocol Code Number:Nauck-2008-1
    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:2008-10-10
    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 number2008-001663-11
    A.3Full title of the trial
    Quantification of the DPP-4 inhibition-mediated enhancement of the activity of the entero-insular axis
    A.4.1Sponsor's protocol code numberNauck-2008-1
    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 SponsorDiabeteszentrum Bad Lauterberg
    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 Yes
    D.2.1.1.1Trade name Januvia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, Sharp & Dohme Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Coated 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 INNSitagliptinphosphat
    D.3.9.1CAS number 654671-77-9
    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.IMP: 2
    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 Metformin Hydrochloride Extended- Release Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderApotex Corp.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Coated 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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115704
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Diabetes Type 2
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of co-administration of sitagliptin and metformin compared to placebo on the incretin effect (based on the comparison of the insulin secretory response to oral glucose load and an "isoglycemic" intravenous glucose load)
    E.2.2Secondary objectives of the trial
    To assess the effect of sitagliptin compared with placebo on the incretin effect (based on the comparison of the insulin secretory response to oral glucose load and an "isoglycemic" intravenous glucose load).

    To assess the effect of co-administration of sitagliptin and metformin compared with sitagliptin alone and metformin alone on the incretin effect (based on the comparison of the insulin secretory response to oral glucose load and an "isoglycemic" intravenous glucose load).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Visit 1 (Screening):
    a. Patient has type 2 diabetes mellitus (T2DM) (according to ADA criteria). Note: an OGTT may be performed to confirm diagnosis of T2DM
    b. Patient is ≥ 30 and ≤ 75 years of age on the day of signing informed consent.
    c. Patient has a BMI that is ≥ 25 and ≤ 35 kg/m2.
    d. Patient is currently not on an OHA medication and has a Screening/Visit 1 HbA1c ≥ 6.5% and ≤ 9% or is on OHA monotherapy with metformin or a sulfonylurea and has a Screening/Visit 1 HbA1c ≥ 6% and ≤ 8.5%
    e. Patient is a male, or a female who is unlikely to conceive, as indicated by at least 1 “yes” answer to the following questions:
    1) Patient is a male.
    2) Patient is a surgically sterilized female.
    3) Patient is a postmenopausal female ≥ 45 years of age with > 2 years since last menses.
    4) Patient is a non-sterilized, premenopausal female and agrees to abstain from heterosexual activity or to use an adequate method of contraception to prevent pregnancy. Note: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
    f. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    g. Agreement to maintain prior diet and exercise habits during the full course of the study.
    h. Ability to comply with all study requirements.

    At Visit 3
    i. Patient has an FPG of ≥ 110 mg/dL (6.1 mmol/L) and ≤220 mg/dL (12.2 mmol/L).
    Note: If the Visit 3 FPG does not meet this criterion AND is not consistent with the patient's recent fasting SBGM values, a single repeat measurement may be performed at the discretion of the investigator. If repeat value meets FPG inclusion criterion, patient may continue in the study.

    At Visit 4
    j. Patient is ≥ 80% compliant with study medication during the single-blind placebo run-in (as determined by tablet count).
    E.4Principal exclusion criteria
    At Visit 1
    a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
    b. Patient is assessed by the investigator as possibly having type I diabetes confirmed with a C-peptide ≤ 0.7 ng/mL (0.23 nmol/L). Note: Only patients assessed by the investigator as possibly having type I diabetes should have C-peptide measured at Visit 1.
    c. Patient has been taking oral anti-hyperglycemic agent (OHA) within the prior 12 weeks, except metformin or a sulfonylurea.
    d. Patient has required insulin therapy within the past 12 weeks. Note: patients who received a brief period of insulin treatment (e.g., several days during a hospitalization) and who are no longer requiring insulin treatment may participate.
    Patients Requiring Specific Treatments
    e. Patient is on a weight loss program and is not in the maintenance phase, or patient started weight loss medication (e.g., orlistat, sibutramine, or rimonabant) within the prior 8 weeks.
    f. Patient is on or likely to require treatment with ≥ 2 consecutive days or repeated courses of pharmacologic doses of corticosteroids, or requires steroid replacement therapy (i.e., in patients with adrenal insufficiency)
    Exception: Topical or inhaled corticosteroids are permitted in the study.
    g. Patient is being treated with immunosuppressive or immunomodulating agents (e.g., cyclosporine, metotrexate).
    h. Patient is currently participating or has participated in a study with an investigational compound or device within 12 weeks or 5 half-lives of signing informed consent.
    i. Patient has undergone a surgical procedure within 4 weeks prior to signing informed consent. Exception: Patient with a history of minor surgery (i.e. using local anesthesia, like for removal of basal cell carcinoma, cataract, etc) within 4 weeks of signing informed consent and is fully recovered may participate.
    j. Patient has a history of intolerance or hypersensitivity to a DPP- 4- inhibitor or metformin or has any contraindication to DPP-4 inhibitors or metformin based upon label of the country of the investigational site.
    Concomitant Disease of Organs and Systems
    k. Patient has laboratory values as listed below:
    Parameter Values
    Creatinine Clearance < 70 mL/min
    ALT† > 2 times ULN
    AST† > 2 times ULN
    TSH Outside of normal range
    TG > 600 mg/dL (> 4.5 mmol/L)
    MDRD estimated creatinine clearance
    † Patients whose serum ALT or AST exceeds this limit may be retested one time if the investigator does not believe the value reflects the patient’s status.
    l. Patient has evidence of a significant cardiovascular disorder within 6 months of signing informed consent (e.g. acute coronary syndrome [e.g. MI or unstable angina], new or worsening angina; coronary artery intervention [e.g., CABG or PTCA]; stroke or transient ischemic neurological disorder).
    m. Patient has congestive heart failure that requires pharmacological treatment
    n. Patient has a systolic blood pressure of ≥ 160 mmHg or diastolic blood pressure of ≥ 95 mmHg. Note: Investigators are encouraged to maximize blood pressure control according to current guidelines. Patient may have blood pressure medication adjusted and be enrolled if repeat blood pressure measurement no longer meets exclusion criterion at Visit 3/Week -2.
    o. Patient has a history of malignancy. Exceptions: (1) Patients with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate; (2) Patients with other malignancies which have been successfully treated for ≥ 5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening; and (3) Patients, who, in the opinion of the investigator, are highly unlikely to sustain a recurrence during the duration of the study. However, patients with a history of bladder carcinoma, leukemia, lymphoma, myeloproliferative or myelodysplastic diseases, malignant melanoma, renal cell carcinoma are ineligible for the study regardless of the time since treatment, and in such cases, no exceptions will apply.
    p. Patient is pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
    q. Patient is expecting to donate eggs within the projected duration of the study.
    r. Patient has HIV (as assessed by medical history)
    s. Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including biliary cirrhosis.
    t. Patient is being treated for hyperthyroidism.
    u. Patient has any other condition or therapy which, in the opinion of the investigator might pose a risk to the patient or make participation not in the patient’s best interest.
    E.5 End points
    E.5.1Primary end point(s)
    The effect of co-administration of sitagliptin and metformin compared to placebo on the incretin effect (based on the comparison of the insulin secretory response to oral glucose load and an ‘isoglycemic’ intravenous glucose load).
    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 Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    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 Yes
    E.6.13.1Other scope of the trial description
    Mechanism of Action
    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) No
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    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 years
    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 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 2008-10-10. 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 state20
    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 Decision2008-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-10
    P. End of Trial
    P.End of Trial StatusOngoing
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