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    Summary
    EudraCT Number:2010-019665-28
    Sponsor's Protocol Code Number:10-HM11260C-201
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-019665-28
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SEQUENTIAL DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF SINGLE SUBCUTANEOUS DOSES OF HM11260C IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS
    A.3.2Name or abbreviated title of the trial where available
    HM11260C SAD study in patients with type 2 diabetes mellitus
    A.4.1Sponsor's protocol code number10-HM11260C-201
    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 SponsorHanmi Pharmaceutical Company Limited
    B.1.3.4CountryKorea, Republic of
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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 nameHM11260C
    D.3.2Product code HM11260C
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHM11260C
    D.3.9.3Other descriptive nameHM11260C
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 20
    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 placeboInjection*
    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
    type 2 diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.2Term 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 evaluate the safety and tolerability profile of single escalating subcutaneous (sc) dose levels of HM11260C in adult patients with type 2 diabetes mellitus
    E.2.2Secondary objectives of the trial
    to evaluate the dose response relationship of single escalating sc dose levels of HM11260C on pharmacodynamic (PD) parameters including 24-h glucose profiles (including fasting and post-prandial blood glucose), fasting fructosamine, C-peptide, fasting insulin, glucagon, lipids, gastric emptying, body weight, waist circumference, and a battery of safety laboratory parameters, incl. amylase, lipase, liver enzymes and hematologic parameters
    to evaluate the pharmacokinetic (PK) profiles of single dose levels of HM11260C
    to determine the pharmacologically active dose (PAD) of HM11260C (based on fasting glucose) as defined by the dose that results in a mean reduction in fasting glucose of more than 30 mg/dL (1.66 mmol/L) or 20% reduction from baseline, whichever is greater
    to assess the immunogenicity (anti-HM11260C antibodies and anti-HM11260C neutralizing antibodies) of a single sc dose of HM11260C
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Gender : male/female
    2. Age : 18 - 75 years, inclusive
    3. BMI : 25 - 40 kg/m2 [Body Mass Index (BMI) (kg/m2) = Body weight (kg)  Height2 (m2)]
    4. Patients with type 2 diabetes mellitus for at least 3 months with fasting glucose <240 mg/dL (<13.3 mmol/L) and HbA1c (glycosylated haemoglobin) between 6.0 and 10% inclusive
    5. Must be treated with:
    a. Diet and exercise only, or
    b. A stable dose of one oral anti-diabetes medication, such as Metformin, sulphonylurea (SU), or a combination of Metformin and SU for 2 months before screening
    6. Must be willing to wash-out glucose lowering drugs for 14 days prior to dosing
    7. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research centre until discharge
    8. Are nonsmokers or smoker of fewer than 5 cigarettes/cigars/pipes per day as determined by history
    9. Medical history without major pathology
    10. Resting supine blood pressure between 90/40 mmHg and 150/95 mmHg, a resting pulse rate of 40 bpm or higher, and showing no clinically relevant deviations as judged by the Medical Investigator
    11. Computerised (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Medical Investigator
    12. Male subjects who are, and whose partners are, willing to use adequate contraception (double barrier method with spermicide) from the time of first dose until 3 months after the follow-up visit
    13. Females who have a negative pregnancy test at screening and on each admission, and are of NCBP. NCBP females are defined as follows: Female subjects must be surgically sterile or post-menopausal (defined as at least 1 year post cessation of menses, follicular stimulating hormone >23.0 mIU/mL and serum oestradiol <163.3 pmol/L)
    14. All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Medical Investigator
    15. Willingness to sign the written Informed Consent Form (ICF)
    E.4Principal exclusion criteria
    1. Positive for HBsAg, HIV or HCV
    2. ALAT and ASAT liver enzymes above two times upper limit of normal
    3. History of metabolic disease other than diabetes and dyslipidemia
    4. Previous use of insulin for diabetes
    5. History of alcohol abuse within 5 years prior to study entry or drug addiction (including soft drugs like cannabis products)
    6. History of any cancer within 5 years prior to study entry (with the exception of non-melanoma skin cancer)
    7. History of thyroid cancer at any point in time
    8. Clinically significant cardiovascular disease
    9. Lactating women
    10. History of pancreatitis
    11. History of other severe gastrointestinal diseases
    12. History of relevant drug and/or food allergies
    13. Previously treated with a GLP-1 analogue
    14. Any other laboratory abnormality which in the opinion of the investigator could interfere with the efficacy or safety evaluations of HM11260C
    15. Mental handicap
    16. Use of concomitant medication, except for multivitamins and vitamin C, which are allowed up to 7 days prior to the first dose. Also use of stable co-medication with cholesterol and blood pressure lowering and alpha blockers is allowed during the study unless pharmacological interaction with the study compound is being expected. The use of a limited amount of acetaminophen is permitted. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John’s Wort extract) must have been stopped at least 14 days prior to the first dose.
    17. Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months preceding the start of this study (this is the first administration of study drug).
    18. Donation of more than 50 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood (for men) / more than 1.0 litres of blood (for women) in the 10 months preceding the start of this study.
    19. Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol
    20. Intake of more than 24 units of alcohol per week (PRA standard: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
    21. Illness within five days prior to drug administration
    22. Intake within 48 h prior to the baseline 13C-breath test of corn, whatever its form (including corn flakes and corn-containing cereals or chips, popcorn, corn oil, polenta), cane sugar, exotic fruits (mangoes, pineapples, papaya, kiwis), fruits in syrup, dessert creams, ice creams, purslane and millet
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamics :
    glucose, insulin, C-peptide and glucagon concentrations, fructosamine and lipids (total cholesterol, HDL, LDL, VLDL, free fatty acids, triglycerides) concentrations, 13C-breath tests as a measure of gastric emptying, and Hunger, Craving and Fullness Questionnaire (VAS)
    Pharmacokinetics :
    serum HM11260C concentrations, PK parameters
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) 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 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.8.3 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 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
    N/A
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) No
    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 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 state30
    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)
    N/A
    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 Decision2010-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-22
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