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    Summary
    EudraCT Number:2012-005660-98
    Sponsor's Protocol Code Number:2012-005660-98
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-12
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-005660-98
    A.3Full title of the trial
    Effect of a single oral dose DPP-4 inhibitor sitagliptin on islet function after intake of a standardized mixed meal in patients with type 2 diabetes
    Effekt av Sitagliptin 100mg på regleringen av insulinsekretion och blodglukos efter intag av en standard måltid hos patienter med typ 2 diabetes mellitus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of a single oral dose DPP-4 inhibitor sitagliptin on islet function after intake of a standardized mixed meal in patients with type 2 diabetes
    A.4.1Sponsor's protocol code number2012-005660-98
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLund University
    B.1.3.4CountrySweden
    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 supportLund University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLund University
    B.5.2Functional name of contact pointBo Ahrén
    B.5.3 Address:
    B.5.3.1Street AddressB11 BMC
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22184
    B.5.3.4CountrySweden
    B.5.4Telephone number46462220758
    B.5.5Fax number4646 222 07 57
    B.5.6E-mailbo.ahren@med.lu.se
    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 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameSitagliptin
    D.3.2Product code Sitagliptin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes mellitus.
    Typ 2 diabetes mellitus.
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus.
    Typ 2 diabetes mellitus
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 examine the acute effect of sitagliptin as a single dose on insulin and glucose levels after ingestion of a standardized mixed meal in men with type 2 diabetes.
    E.2.2Secondary objectives of the trial
    To examine the acute effect of sitagliptin as a single dose on glucagon, activa and total GIP, activa and total GLP-1 levels and insulin secretory rate after ingestion of a standardized mixed meal in men with type 2 diabetes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Caucasian men with type 2 diabetes diagnosed according to ICD10
    • Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic . Metformin therapy should not exceed 2 grams daily
    • Age 20-75 years
    • HbA1c ≤80 mmol/mol
    • BMI: 20-40 kg/m2
    • Written informed consent has been given
    • Capability and willingness to participate in the whole study
    E.4Principal exclusion criteria
    • Liver disease or ALAT three times above upper reference range
    • Diabetic nephropathy (GFR < 50 ml/min/1.73 m2 or albuminuria)
    • Proliferative diabetic retinopathy
    • Treatment with any glucose-lowering medication except metformin
    • Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months.
    • Previous surgery on the gastrointestinal tract
    • Larger surgical intervention during the last 12 weeks
    • Treatment with oral steroids or thiazide diuretics
    • Treatment with digoxin
    • Smokers
    • Participation in another study the last 4 weeks
    • Paracetamol intolerance
    E.5 End points
    E.5.1Primary end point(s)
    • The area under the 180 min curves for plasma insulin concentrations
    • The area under the 180 min curves for plasma glucose
    E.5.1.1Timepoint(s) of evaluation of this end point
    0-180 min after meal ingestion
    E.5.2Secondary end point(s)
    - The area under the 180 min curves for glucagon, total and intact GIP and total and intact GLP-1 concentrations
    - The area under the 30 min curves for insulin, glucagon, total and intact GIP and total and intact GLP-1 concentrations
    - Ratio of area under the curves (180 min) for intact to total GIP and GLP-1
    - Insulin secretion rate and glucose sensitivity of the ß-cells as determined by C-peptide convolution of the data.
    E.5.2.1Timepoint(s) of evaluation of this end point
    0-180 min after meal ingestion
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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) 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    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
    The end of the trial is the last visit of the last patient.
    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 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.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The aim is to examine the acute effect of sitagliptin as a single dose on islet cell function after ingestion of a standardized mixed meal in men with type 2 diabetes.The participating individual in this trail will continue with their medications as they had before the study start unchanged.
    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 Decision2013-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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