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    Summary
    EudraCT Number:2012-000592-17
    Sponsor's Protocol Code Number:MODY-TREAT
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-000592-17
    A.3Full title of the trial
    The effects of GLP-1 in Maturity- onset diabetes of the young (MODY)
    Effekten af GLP-1 i maturity onset diabetes of the young (MODY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of the gut hormone GLP-1 in patients with Maturity- onset diabetes of the young (MODY)
    Effekten af tarmhormonet GLP-1 hos patienter med maturity- onset diabetes of the young (MODY)
    A.4.1Sponsor's protocol code numberMODY-TREAT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01610934
    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 SponsorSigne H. Østoft, Diabetes Research Division
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSigne H. Østoft, Diabetes Research Division
    B.5.2Functional name of contact pointClinical trials information
    B.5.3 Address:
    B.5.3.1Street AddressGentofte Hospital, Niels Andersen Vej 65, opg. 7, 3.sal
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4521230343
    B.5.6E-mails.ostoft@dadlnet.dk
    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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1.8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 RoleComparator
    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 Amaryl
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis Denmark A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNGLIMEPIRIDE
    D.3.9.1CAS number 93479-97-1
    D.3.9.4EV Substance CodeSUB07925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    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
    'Maturity onset diabetes of the young', also called 'Hepatocyte nuclear factor 1-alfa daiabetes'. It is a monogenic form of inherited diabetes.
    E.1.1.1Medical condition in easily understood language
    An inherited form of diabetes where only a single gene is affected. The desease resembles type 2 diabetes, but the patients are younger.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10026948
    E.1.2Term Maturity-onset diabetes of the young
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to investigate long term (6 weeks) effects of liraglutide compared to glimepiride on Fasting Plasma Glucose in patients with MODY3 in a double-blind, randomised cross-over trial.
    E.2.2Secondary objectives of the trial
    To investigate the risk of hypoglycaemia during treatment with liraglutide and glimepiride.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Caucasian above 18 years of age
    • Well characterised MODY3
    • Body mass index (BMI) >19 kg/m2
    • Normal haemoglobin (males >8.2 mM, females >7.2 mM)
    • Normal blood pressure (<160/100 mmHg)
    • Informed consent
    • Capability to perform a light cycling test (heart rate 100-120 beats per minute during 30 minutes)
    • Females: use of anticonception (IUC or hormonal)
    E.4Principal exclusion criteria
    • Heart failure: New York Heart Association class III-IV
    • Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine >130 µM and/or albuminuria
    • Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 × upper normal serum levels)
    • Anaemia
    • Acute or chronic pancreatitis
    • Struma or thyroid cancer
    • Pregnancy or breast feeding
    • Inability to complete the study
    • Treatment naïve patients with HbA1c <7.0 %
    • Treatment with medicine that can not be paused for 12 hours
    • Known allergic reaction to study medication
    • Intention to become pregnant
    • Unwillingness to complete the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Fasting PG (FPG)
    Glycaemic control will be evaluated by FPG monitored twice weekly, 7-point PG profiles every two weeks and 3 blinded 48-hour continuous PG profiles (before randomisation and at the end of both treatment periods). The patients who will be their own controls, will randomly be assigned (after one week washout of usual antidiabetic treatment) to receive either liraglutide or glimepiride for 6 weeks, and after another one-week washout period treated with the opposite treatment for 6 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline (end of 1st wash-out period), and in the end of each treatment period.
    E.5.2Secondary end point(s)
    Secondary endpoints include: serum fructosamine, number and severity of hypoglycaemic events, estimation of endocrine pancreas function (plasma concentrations of insulin, C-peptide and glucagon) and plasma concentrations of incretin hormones. Postprandial responses of incretin hormones and beta cell function (assessed as fasting proinsulin-to-insulin ratio) will be evaluated during three standardised 4-hour meal tests (at baseline and in the end of each treatment period). Hypoglycaemic events will be reported by the patient in a diary. During cycling tests patients will be tested further according to hypoglycaemia. Mild hypoglycaemia is defined as episodes with symptoms of hypoglycaemia familiar to the patient and managed solely by the patient. Events of severe hypoglycaemia are defined as episodes with symptoms of hypoglycaemia with need for assistance from another person. Such events must be reported to the investigator within 24 hours after the event. Episodes of severe hypoglycaemia will be validated as follows: 1) symptoms of hypoglycaemia; 2) PG <3.0 mM; and 3) adequate response to glucose/glucagon treatment. Episodes fulfilling all three criteria will be classified as definite; those fulfilling two criteria with no other explanation of the symptoms will be classified as probable, and those only fulfilling one criterion will be classified as possible. Severity will be sub-classified according to level of assistance and consciousness during the episode: 1) conscious during the event, but with need of assistance to treat orally with glucose; 2) coma or seizure during the event and/or if parenteral treatment is necessary. Biochemical hypoglycaemia is defined as PG <3.0 mM.

    Fructosamine
    Fructosamine is a time-averaged indicator of PG levels, which is used to assess the glycaemic status of patients with diabetes. It reflects the total amount of glycated proteins such as glycohaemoglobin and glycoalbumin in a blood sample. The concentration of glycated proteins is generally recognized to be valuable in evaluating the glycaemic status of patients with diabetes. It is simple compared to other methods used for such determinations such as affinity chromatography and the thiobarbituric acid method, which are labour-intensive and time consuming and results obtained from different laboratories are difficult to compare. The turnover of serum proteins (albumin has a half-life of 19 days) is less than that of haemoglobin (lifespan of erythrocytes is approximately 120 days), and therefore fructosamine determinations provide a means of monitoring patient blood glucose status over a shorter period (1-3 weeks) than glycohaemoglobin (6-8 weeks). As a result, changes in fructosamine values alert the physician to deteriorating glycaemic control earlier than changes in HbA1c values. In addition, fructosamine levels decrease more quickly than HbA1c when antidiabetic treatment is optimised (12).

    Cycling test
    Patients will be evaluated during a cycling test. The number of patients experiencing hypoglycaemia during a 30-minute bicycle exercise test 2½ hours after ingestion of a standardised test meal will be noted. PG will be evaluated at predefined time intervals throughout the study in order to evaluate biochemical hypoglycaemia. All patients will be tested three times: at baseline (after one week washout of usual antidiabetic treatment and in the end of each treatment period. Two and a half hours after ingestion of a test meal (375 kcal, 46 g carbohydrate, 14.5 g fat and 15 g protein) all patients will be subjected to a 30-minute cycling test (50-60 revolutions/min with adjustment of the bicycle resistance to fix the heart rate at 100-120 beats/min throughout the test) (10). Patients will ingest the meal 30 minutes after administration of study medication.

    Endocrine measures and hypoglycaemia
    Endocrine pancreas function will be estimated by analyses of plasma concentrations of insulin, C-peptide and glucagon. Other hormone analyses include cortisol, epinephrine, nor-epinephrine, growth hormone and incretin hormones. Furthermore, observation of symptoms of hypoglycaemia including sweating, tremor, confusion, nausea, nervousness, weakness, hunger, trouble speaking, palpitations, anxiety and irritability will be noted. Mild hypoglycaemia is defined as episodes with symptoms of hypoglycaemia familiar to the patient and managed solely by the patient. Biochemical hypoglycaemia: is defined as PG <3 mM without symptoms of hypoglycaemia. Severe hypoglycaemia is defined as episodes with symptoms of hypoglycaemia with need for assistance from another person. Severity will be sub-classified according to level of assistance and consciousness during the episode: 1) conscious during the event, but with need of assistance to treat orally with glucose; 2) coma or seizure during the event and/or if parenteral treatment is necessary.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline (end of 1st wash-out period), and in the end of each treatment period.
    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 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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state16
    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)
    Patients will be treated with their usual medidication- the medication they were treated with prior to participating in the trial.
    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 Decision2012-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-23
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