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    Summary
    EudraCT Number:2006-004489-15
    Sponsor's Protocol Code Number:MKC-TI-118
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-004489-15
    A.3Full title of the trial
    Comparison of Technosphere®/Insulin, Insulin Lispro and Exubera® Effect on Endogenous Glucose Production After a Meal Challenge and During a Euglycemic Glucose Clamp Procedure in Subjects with Type 2 Diabetes
    A.4.1Sponsor's protocol code numberMKC-TI-118
    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 nameTechnosphere®/Insulin
    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.3.8INN - Proposed INNInsulin Human rDNA
    D.3.9.1CAS number 11061-68-0
    D.3.9.3Other descriptive nameInsulin Human, USP
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) 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 typeHormone Replacement Therapy
    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 Humalog®
    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.3.1Product nameInsulin Lispro
    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.3.8INN - Proposed INNInsulin Lispro
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 typeHormone Replacement Therapy
    D.IMP: 3
    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 Exubera®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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.3.1Product nameExubera®
    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.3.8INN - Proposed INN Human Insulin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Insulin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) 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 typeHormone Replacement Therapy
    D.8 Information on Placebo
    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 PT
    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
    The primary objective of this trial is to assess EGP after dosing with TI Inhalation Powder and compare it to EGP after sc administration of insulin lispro or inhalation of Exubera insulin during a meal challenge with 12 fluid ounces of Boost plus®.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to:
    • Assess EGP after dosing with TI Inhalation Powder in comparison to EGP after sc administration of Insulin Lispro and inhalation of Exubera insulin during a euglycemic glucose clamp procedure.
    • Characterize the pharmacokinetic and pharmacodynamic properties of TI Inhalation Powder, Insulin Lispro or Exubera insulin.
    • Assess the effect of TI Inhalation Powder, Insulin Lispro or Exubera insulin on endogenous insulin secretion.
    • Assess the effect of the 3 treatments on C-peptide, glucagon and free fatty acids (FFA) concentrations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible subjects must meet all of the following inclusion criteria:
    1. Males and females ≥ 18 and ≤ 70 years of age;
    2. Clinical diagnosis of type 2 diabetes mellitus for ≥ 12 months;
    3. Receiving diabetes treatment with insulin for a minimum of 3 months;
    4. Body Mass Index (BMI) of ≤ 34 kg/m2 and ≥ 25 kg/m2;
    5. HbA1c ≤ of 8.5% based upon results from a central laboratory;
    6. PFTs:
    • An FEV1 to FVC ratio ≥ 70% and an FVC ≥ 80%;
    • Amendment 1: FEV1 ≥ 70% predicted; FEV1/FVC ratio ≥ 70%
    • Single-breath carbon monoxide diffusing capacity (DLco uncorrected) ≥ 70% of Predicted (Miller)
    7. Urine cotinine of ≤ 100ng/dL
    8. Be willing to sign a written Informed Consent
    E.4Principal exclusion criteria
    1. Total daily insulin requirement of ≥ 1.2 U/kg body weight;
    2. Use of Symlin® (pramlintide acetate) and/or Byetta® (exenatide) within the preceding 8 weeks;
    3. Two or more severe hypoglycemic episodes within 6 months of screening;
    4. Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening;
    5. Severe complications of diabetes
    6. Previous exposure to any inhaled insulin product;
    7. Currently using an insulin delivery pump;
    8. Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial or a history of hypersensitivity to Technosphere®/Placebo, T/I or to drugs with a similar chemical structure;
    9. Any clinically important pulmonary disease, confirmed by documented history,
    pulmonary function testing, or radiologic findings;
    10. Chronic use of systemic steroids;
    11. Inability to perform PFT maneuvers to meet the recommended ATS standards of acceptability and repeatability;
    12. Significant improvement in spirometry following bronchodilation defined as at least 12% and a 200 mL increase in either the FVC or the FEV1;
    13. Active respiratory infection; however, the subject may return for Screening, Visit 1, after 30 days from resolution of the respiratory condition.
    14. Clinically significant major organ system disease such as:
    - Seizure disorder;
    - Significant cardiovascular dysfunction and/or history within 3 months of Screening,
    such as congestive heart failure (NYHA Class III or IV; Appendix B) or serious
    arrhythmia (Amiodarone is an exclusionary medication), myocardial infarction,
    cardiac surgery, recurrent syncope, transient ischemic attacks or cerebrovascular
    accident;
    - Uncontrolled hypertension with a systolic blood pressure of >160 mm Hg and/or
    diastolic blood pressure > 95 mm Hg at screening, despite pharmacologic treatment;
    - Clinical nephrotic syndrome or renal dysfunction or disease, serum creatinine
    > 2.0 mg/dL in males and > 1.8 mg/dL in females and/or Blood Urea Nitrogen (BUN)
    > 50 mg/dL;
    - Cancer (other than an excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms;
    - History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes, as evidenced by serum aspartate aminotransferase [AST] and/or alanine
    aminotransferase [ALT] and/or gamma glutamyl-transferase [GGT] ≥ 3x Upper Limit
    of Normal (ULN);
    - Active infection eg, Human Immunodeficiency Virus (HIV), Hepatitis, or history of
    severe infection within 30 days of Visit 1 (Screening);
    - Anemia (hemoglobin value below lower limit of normal);
    - A previous diagnosis of systemic autoimmune or collagen vascular disease requiring
    prior or current treatment with systemic corticosteroids, cytotoxic drugs or
    penicillamine;
    - Any concurrent illness, other than diabetes mellitus and mild COPD, not controlled
    by a stable therapeutic regime as judged by the investigator;
    15. Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity;
    16. Clinically significant abnormalities on screening laboratory evaluation (unless discussed with and approved by the Medical Monitor);
    17. Female subjects who are pregnant, lactating or planning to become pregnant during the clinical trial period;
    18. Female subjects of childbearing potential (defined as pre-menopausal and not surgically sterilized or post-menopausal for less than 2 years) not practicing adequate birth control.
    19. Current drug or alcohol abuse, or a history of drug or alcohol abuse, that, in the opinion of the PI, would not make the subject a suitable candidate for participation in the clinical trial;
    20. Exposure to any investigational medications or devices within the previous 30 days prior to trial entry or participation in another clinical trial during this trial;
    21. Unable and/or unlikely to comprehend and/or follow the trial protocol;
    22. Unable and/or unlikely to comprehend how to use the MedTone® Inhaler or inability to use the device;
    23. Concurrent medical or major psychiatric condition which, 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.
    E.5 End points
    E.5.1Primary end point(s)
    EGP, area over the concentration-time curve (AOC) for EGP (AOCEGP), minimum (EGPmin), and time to (tEGPmin) after a meal challenge with Boost Plus®.
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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.8.3 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.8.5.1Number 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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 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 state22
    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)
    At the end of each treatment visit, all subjects will return to their previous anti-diabetic drug.
    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 Decision2007-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-31
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