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    Summary
    EudraCT Number:2017-000204-15
    Sponsor's Protocol Code Number:060286
    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:2017-05-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-000204-15
    A.3Full title of the trial
    Glimepiride monotherapy vs. combination of glimepiride and linagliptin therapy in patients with HNF1A-diabetes
    Glimepiridbehandling vs. kombinationsbehandling med glimepirid og linagliptin i patienter med HNF1A-diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glimepiride monotherapy vs. combination of glimepiride and linagliptin therapy in patients with maturity onset diabetes of the young type 3 (MODY3)
    Glimepiridbehandling vs. kombinationsbehandling med glimepirid og linagliptin i patienter med arveligt betinget diabetes (MODY type 3).
    A.3.2Name or abbreviated title of the trial where available
    GLIMLINA-trial
    A.4.1Sponsor's protocol code number060286
    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 SponsorProfessor, DMSc Tina Vilsbøll
    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 supportBoehringer Ingelheim Denmark A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSteno Diabetes Center Copenhagen, Gentofte Hospital
    B.5.2Functional name of contact pointClinical Metabolic Physiology
    B.5.3 Address:
    B.5.3.1Street AddressKildegårdsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.6E-mailtina.vilsboell.lauritsen.01@regionh.dk
    D. IMP Identification
    D.IMP: 1
    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 Glimepiride STADA
    D.2.1.1.2Name of the Marketing Authorisation holderStada Arzneimittel AG
    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 typeequal
    D.3.10.3Concentration number1
    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.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 Trajenta
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH Binger Str. 173 D-55216 Ingelheim am Rhein Tyskland
    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 INNLINAGLIPTIN
    D.3.9.1CAS number 668270-12-0
    D.3.9.3Other descriptive nameLINAGLIPTIN
    D.3.9.4EV Substance CodeSUB31340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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
    "Hepatocyte nuclear factor 1-alfa diabetes", also called "Maturity onset diabetes of the young type 3"'. 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 disease 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10026948
    E.1.2Term Maturity-onset diabetes of the young
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this trial is to investigate the effect of glimepiride + linagliptin vs. glimepiride + placebo on glycaemic variability in patients with hepatocyte nuclear factor 1-alpha (HNF1A) diabetes in a double-blind, randomised, cross-over trial. HNF1A-diabetes is also known as maturity onset diabetes of the young type 3 (MODY3).
    E.2.2Secondary objectives of the trial
    Among other to investigate longterm glycaemic control (HbA1c) and risk of hypoglycaemia during treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with hepatocyte nuclear factor 1-alpha (HNF1A) diabetes caused by heterozygous mutation in HNF1A confirmed by Sanger sequencing of the gene
    • Monotherapy with diet or a stable dose of glimepiride of (≥0.5 mg per day) during four weeks
    • Patients on glimepiride HbA1c ≥6.5% (HbA1c ≥47 mmol/mol); treatment naïve patients HbA1c ≥7.0% (HbA1c ≥53 mmol/mol)
    • Age ≥18 years of age
    • Capability to perform a 30 minute light bicycle test at a heart rate of 100-120 beats per min
    • Fertile females: use of anticonception (intrauterine contraceptive devices or hormonal contraception)
    • Informed consent
    E.4Principal exclusion criteria
    • Glucose-lowering drugs other than glimepiride
    • Uraemia, end-stage renal disease or estimated glomerular filtration rate <30 ml/min/1.73m2 and/or albuminuria
    • Liver disease and/or alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 × upper normal serum levels
    • Anaemia (males blood haemoglobin <8.0 mmol/l and females <7.0 mmol/l)
    • History of acute and/or chronic pancreatitis
    • Pregnancy or breast feeding
    • Inability to complete the study
    • Known allergic reaction to study medication
    • Intention to become pregnant
    E.5 End points
    E.5.1Primary end point(s)
    Mean amplitude of glycaemic excursions (MAGE)

    The primary endpoint is the absolute difference in MAGE between the two treatments (glimepiride + linagliptin vs. glimepiride + placebo) at the end of each treatment period calculated from six days (144 hours) of continuous glucose monitoring (CGM).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and end of both treatment periods.
    E.5.2Secondary end point(s)
    Secondary endpoints include differences between the two treatments (glimepiride + linagliptin vs. glimepiride + placebo) in:

    • Other parameters of glycaemic variability including low blood glucose index (LBGI), standard deviation of mean glucose, time spent in hypoglycaemia and time spent in hyperglycaemia calculated from six days of CGM at the end of each treatment period .
    • Difference between baseline and end of treatment in parameters of glycaemic variability including MAGE, LBGI, standard deviation of mean glucose, time spent in hypoglycaemia, time spent in hyperglycaemia from six days of CGM monitoring.
    • Glycaemic excursion and endocrine function during a 4-hour meal and bicycle test
    • Plasma/serum concentrations of insulin, C-peptide, glucagon, GIP, GLP-1, growth hormone (GH), cortisol, epinephrine and norepinephrine during a 4-hour meal and bicycle test
    • Number and severity of hypoglycaemic events during meal and bicycle tests
    • Number and severity of hypoglycaemic events during treatment periods
    • Fasting plasma glucose (FPG) at the end of each treatment period
    • Glycated haemoglobin (HbA1c) at end of trial
    • Change in bodyweight from baseline
    • Change in fructosamine at end of treatment
    • Changes in cardiovascular biomarkers in urine
    • Changes in quality of life from baseline evaluated with Short Form 36 (SF-36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline 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) No
    E.8.2.2Placebo Yes
    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 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: 18
    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 state20
    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)
    None
    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 Decision2017-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-26
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