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    Summary
    EudraCT Number:2012-001941-42
    Sponsor's Protocol Code Number:MDILiraglutid01/2012
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-16
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-001941-42
    A.3Full title of the trial
    Addition of liraglutide to overweight patients with type 2 diabetes treated with multiple daily insulin injections (MDI) with inadequate glycaemic control
    Tillägg av liraglutid hos överviktiga patienter med typ 2 diabetes som behandlas med insulininjektioner flera gånger dagligen och som har dålig glykemisk kontroll
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Liraglutide to overweight patients with insulin treated type 2 diabetes
    Liraglutid till överviktiga patienter med insulinbehandlad typ 2 diabetes
    A.4.1Sponsor's protocol code numberMDILiraglutid01/2012
    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 SponsorVästra Götalandsregionen (VGR)
    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 supportVästra Götalandsregionen
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportNovo Nordisk
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVästra Götalandsregionen
    B.5.2Functional name of contact pointUddevalla Hospital, Medicinkliniken
    B.5.3 Address:
    B.5.3.1Street AddressFjällvägen 9
    B.5.3.2Town/ cityUddevalla
    B.5.3.3Post code451 80
    B.5.3.4CountrySweden
    B.5.4Telephone number+46738311742
    B.5.5Fax number+4652293349
    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, solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes Mellitus Type 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    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 PT
    E.1.2Classification code 10053247
    E.1.2Term Insulin-requiring type 2 diabetes mellitus
    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 primary objective of this study is to determine whether liraglutide, compared to placebo reduces the HbA1c level for type 2 diabetes patients with inadequate glycaemic control treated with multiple daily insulin injections.
    E.2.2Secondary objectives of the trial
    Secondary objectives are comparison of the following variables between diabetic patients with liraglutide added and diabetic patients with placebo added:
    • Weight
    • Fasting glucose
    • Glucose variability
    • Postprandial glucose levels
    • Health-related quality of life
    • Targeted HbA1c
    • Total insulin dose
    • Blood pressure level
    • Hypoglycaemia
    • Blood lipid levels
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    • Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
    • Type 2 diabetes
    • Adult patients over 18 years of age and less than 75 years of age
    • HbA1c greater than 8.0% (NGSP standard=DCCT standard)=64 mmol/mol (IFCC standard) and less than 11.5% (102 mmol/mol)
    • Treated with MDI for at least the last 6 months
    • Treated with/without metformin as only diabetes therapy apart from insulin
    • Fasting C-peptide of 0.2 nmol/l or greater (ref. 0.25-0.75nmol/l)
    • BMI greater than 28 kg/m2 and less than 45 kg/m2
    E.4Principal exclusion criteria
    Exclusion criteria:
    • Type 1 diabetes
    • Fasting glucose less than 7.0 mmol/l or greater than 15 mmol/l
    • Unstable cardiovascular disease, NYHA Class II or greater heart failure , new symptoms of cardiovascular disease)
    • Proliferative diabetic retinopathy or clinically significant macula oedema. Retinal photograph should not be older than 3 years.
    • Systemic glucocorticoid treatment during the last 3 months
    • Acute coronary syndrome, stroke, coronary artery intervention or myocardial infarction during the previous 6 months
    • Creatinine greater than 130 micromol/l
    • Liver transaminases greater than double of the normal reference interval
    • Treatment with other oral antidiabetic agents than metformin during the previous 3 months
    • Treatment with GLP-1 receptor agonists within 90 days of screening
    • Severe psychiatric disorder (untreated severe depression, schizophrenia, dementia or severe alcohol or drug abuse)
    • Frequent non-severe hypoglycaemia (greater than 2 times per week) or any severe hypoglycaemia during the previous month.
    • Hypoglycaemic unawareness
    • Current cancer or diagnosis of cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer).
    • Personal history of non-familial thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)
    • Screening calcitonin values greater than 50 ng/l
    • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice; e.g. oral contraceptive pills and intrauterine device (IUD)).
    • Blood pressure greater than 160/100 mmHg
    • Need for continuous use of paracetamol. During the 3 periods of 7 days with CGM, paracetamol cannot be used. Alternative pain killers can be substituted if plausible because paracetamol is the only medication influencing CGM results.
    • History of chronic or acute pancreatitis
    • Inflammatory Bowel Disease
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint will be change in HbA1c from baseline to week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    HbA1c will be measured at baseline, week 6, week 12, week 18 and week 24.
    E.5.2Secondary end point(s)
    Secondary endpoints will be:
    • Change in weight from baseline to week 24
    • Change in fasting glucose from baseline to week 24
    • Change in the standard deviation of CGM from the run-in period to week 23-24
    • Change in mean glucose levels on CGM from the run-in period to week 23-24
    • Change in 1.5 hour postprandial glucose levels on capillary glucose measurements from the run-in period to week 23-24
    • Change in the score of the DTSQs from baseline to week 24
    • Score of the DTSQc at week 24
    • Proportion of patients with HbA1c less than 8.0% (64 mmol/mol) at week 24
    • Proportion of patients with HbA1c less than 7.5% (58 mmol/mol) at week 24
    • Change in total insulin dose from baseline to week 24
    • Proportion of patients with HbA1c less than 7.0% (53 mmol/mol) at week 24
    • Change in blood pressure from baseline to week 24
    • Frequency of non-severe documented symptomatic hypoglycaemia (plasma glucose [PG] less than 4.0 mmol/l) from baseline to week 24
    • Frequency of asymptomatic non-severe hypoglycaemia (PG less than 4.0 mmol/l) from baseline to week 24
    • Frequency of non-severe documented symptomatic hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24
    • Frequency of asymptomatic non-severe hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24
    • Frequency of severe hypoglycaemia from baseline to week 24
    • Change in blood lipid levels from baseline to week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, 6, 12, 18 and 24 weeks, weight, fasting plasma glucose, HbA1c, total insulin dose, blood pressure, and hypoglycaemias will be recorded.

    At baseline, 12 and 24 weeks, fasting blood lipids

    At baseline and 24 weeks, DTSQs will be recorded.

    At run-in period, 12weeks ± 7 days, and 23-24 weeks, change in standard deviation of CGM, change in mean glucose levels on CGM will be recorded.

    Ar run-in period and 23-24 weeks capillary glucose levels will be recorded.

    At 24 weeks DTSQc will be taken.
    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 No
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    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 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
    Last visit, last subject (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 months12
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state120
    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 Decision2012-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-14
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