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    Summary
    EudraCT Number:2007-003430-42
    Sponsor's Protocol Code Number:MKC-253-002
    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:2007-12-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-003430-42
    A.3Full title of the trial
    A Phase 1, Repeated Single-Dose, Double Blind, Randomized Five Treatment Controlled Safety and Pharmacological Response Evaluation Trial of MKC253 Inhalation Powder in Adult Male and Postmenopausal Female Subjects with Type 2 Diabetes Mellitus
    A.4.1Sponsor's protocol code numberMKC-253-002
    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 SponsorMannKind Corporation
    B.1.3.4CountryUnited States
    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 nameMKC253 (GLP-1 Technosphere®) Inhalation Powder
    D.3.2Product code MKC253
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGLP-1
    D.3.9.3Other descriptive nameGLP-1 (7-36) amide, human GLP-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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 Yes
    D.3.11.13.1Other medicinal product typeMKC253 (GLP-1 Technosphere®) Inhalation Powder is composed of GLP-1 (active drug substance) and Technosphere® particles (crystalline particles of fumaryl diketopiperazine (FDKP) and polysorbate 80).
    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 Byetta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    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.3.9.3Other descriptive nameexenatide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboInhalation powder, pre-dispensed
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II 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
    The objectives of this trial are to determine the safety and pharmacological response of MKC253 (GLP-1/Technosphere®) Inhalation Powder in adult male and postmenopausal female subjects with type 2 diabetes mellitus.

    The primary objective of this trial is to evaluate the effect of MKC253 Inhalation Powder on post-prandial glucose concentrations, expressed as Area Under the Glucose Concentration-Time Curve (AUC), following a standardized meal.
    E.2.2Secondary objectives of the trial
    1. Adverse effects on safety variables, including reported adverse events (AE), vital signs, physical examinations, clinical laboratory tests, pulmonary function tests (PFT) and electrocardiograms (ECG);
    2. Insulin, C-peptide, glucagon (at limited time points) and GLP-1 concentrations (of active, and at limited time points total GLP-1) and Areas Under the Concentration-Time Curves, as well as the maximum post-prandial glucose, insulin and C-peptide excursions from baseline during the pre-treatment to post-treatment interval for each standardized meal;
    3. Time of gastric emptying (T½ and Tlag from the % dose recovered/hour and cumulative % dose curves) as measured by 13C-carbon dioxide clearance when 13C-octanoate is administered with the meal;
    4. Additional PK parameters of plasma GLP-1 include: time of maximum (tmax) plasma GLP-1; maximum (Cmax) plasma GLP-1; and plasma GLP-1 half-life (t1/2).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and postmenopausal or surgically sterile females ≥ 18 and ≤ 70 years of age with Type 2 Diabetes Mellitus. (Post-menopausal is defined as > 24 months amenorrhea; for subjects with amenorrhea < 5 years menopause should be confirmed by FSH testing).
    2. Male subjects, unless surgically sterilized, must be prepared to use effective contraceptive measures to prevent the pregnancy of partner, from screening until 14 days after the end of dosing.
    3. Diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, without any dose adjustments within the preceding 8 weeks. For subjects taking both metformin and sulfonylurea, meglitinide, or alpha glucosidase inhibitor, one or both oral agents must be ≤ half the maximal allowable dose as cited in the product label.
    4. HbA1c ≥ 6.2% to ≤ 8.5%.
    5. Fasting C-peptide ≥ 0.5 ng/mL.
    6. On the last 3 days of the washout period (Days -3, -2, and -1) a fasting blood glucose (FBG) by finger stick ≤ 13.5 mmol/L.
    7. Body Mass Index (BMI) of ≤ 32 kg/m2.
    8. Smoking Status and Urine Cotinine Test:
    • Non-smoker (includes cigarettes, cigars and pipe) for ≥ the preceding 6 months;
    • Negative urine Cotinine Test, defined as ≤ 100 ng/mL;
    9. PFTs:
    • Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ≥ Lower
    Limit of Normal (LLN) National Health and Nutrition Examination Survey (NHANES) III at Screening;
    • FEV1 ≥ 70% of Predicted (NHANES III) at Screening ;
    • TLC ≥ 80% predicted (ITS);
    • Single-breath carbon monoxide diffusing capacity of the lung (DLCO) (uncorrected)
    ≥ 70% of Predicted (Miller); and
    10. Written Informed Consent.
    E.4Principal exclusion criteria
    1. Exposure to any investigational medications or devices within the previous 90 days prior to trial entry or participation in another clinical trial while participating in this trial.
    2. Allergy or known hypersensitivity to any of the drugs to be used in the trial or a history of hypersensitivity to TIP, GLP-1, exenatide, or to drugs with a similar chemical structure.
    3. Use of any prescription medication within 90 days prior to screening, other than allowed anti-diabetic therapy, that has not been approved by the PI and Sponsor. The use of alpha blockers, antihypertensives, proton pump inhibitors and cholesterol medication as comedications is allowed throughout the study.
    4. Treatment with any type of anti-diabetic therapy other than metformin, sulfonylurea, meglitinide and alpha glucosidase inhibitors within the preceding 12 weeks [ie, thiazolinediones (TZDs), dipeptidyl dipeptidase inhibitors (DPP-IV), Symlin (pramlintide acetate) and or Byetta (exenatide)].
    5. Serum creatinine above Upper Limit of Normal (ULN) as defined by the laboratory.
    6. Known symptomatic gastrointestinal disease (GI) disease that may predispose to nausea and/or vomiting (eg, peptic ulcer disease, gastritis or gastric emptying disorder) or any other disorder that may predispose to nausea and/or vomiting (eg, vestibular disorders).
    7. Clinically significant disease including, but not limited to:
    o History of significant psychiatric or neurological disease including seizure disorder and major depression.
    o Cardiovascular, cerebrovascular or peripheral vascular disease or uncontrolled hypertension. (Such as subjects with hypertension who are not medically monitored and treated)
    o Cancer (other than excised cutaneous basal cell carcinoma) or history of benign lung neoplasms.
    o History of active acute or chronic hepatic disease including any history of Hepatitis B, Hepatitis C, or autoimmune liver disease or positive Hepatitis B or C serology on screening laboratories.
    o History of HIV disease or HIV positive on screening laboratories.
    o History of systemic autoimmune or collagen vascular disease.
    8. Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity.
    9. Any abnormalities on screening, hematology, or chemistry laboratory studies, defined as outside of the normal range of the reference laboratory (unless discussed with and approved by the Medical Monitor).
    10. Current drug or alcohol abuse, or a history of drug or alcohol abuse that in the opinion of the PI would make the subject an unsuitable candidate for participation in the clinical trial. An herbal or dietary regimen that in the opinion of the PI would make the subject an unsuitable candidate for participation in the clinical trial.
    11. Unable and/or unlikely to comprehend and/or follow the trial protocol.
    12. A lack of compliance with medication or procedures that in the PI’s opinion may affect the clinical trial data or the subject’s safety and which precludes the subject from further participation in the clinical trial.
    13. Any other condition that in the opinion of the PI makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject’s ability to participate in the trial.
    14. Significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC OR FEV1).
    15. History of chronic obstructive pulmonary disease (COPD), including but not limited to, asthma and/or any other clinically important pulmonary disease, confirmed by pulmonary function testing or radiologic findings.
    16. Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria.
    17. Active respiratory infection [subject may return after 30 days from resolution for Visit 1 (Screening)]; if respiratory infection manifests after Visit 1 (Screening) but prior to Visit 1 PFTs, subject will be considered a screen failure.
    E.5 End points
    E.5.1Primary end point(s)
    AUC0-240 min post-prandial plasma glucose.
    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) Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Last patient last visit.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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 Decision2007-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-10
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