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    Summary
    EudraCT Number:2008-000564-16
    Sponsor's Protocol Code Number:MKC-TI-134
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-04-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-000564-16
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder in Type 1 or Type 2 Diabetic Subjects with Obstructive Pulmonary Disease (Asthma or Chronic Obstructive Pulmonary Disease) Over a 12-month Treatment Period with a 2-month Follow-up
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Eveluation of the safety of Technosphere® Insulin Inhalation Powder on Diabetic Subjects with Obstructive Pulmonary Disease
    A.4.1Sponsor's protocol code numberMKC-TI-134
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00642616
    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 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 supportMannKind Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMannKind Corporation
    B.5.2Functional name of contact pointVice President, Nikhil Amin
    B.5.3 Address:
    B.5.3.1Street Address61 S Paramus Rd
    B.5.3.2Town/ cityParamus
    B.5.3.3Post codeNJ 07652
    B.5.3.4CountryUnited States
    B.5.4Telephone number001201983-5166
    B.5.5Fax number001201450-0750
    B.5.6E-mailnamin@mannkindcorp.com
    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 (TI) Inhalation Powder
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    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 INNRecombinant Human Insulin
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor codeInsulin Human
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(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 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) 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 Yes
    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 Yes
    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 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 (TI) Inhalation Powder
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    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 INNRecombinant Human Insulin
    D.3.9.1CAS number 11061-68-0
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 or type 2 diabetes mellitus and underlying asthma or COPD.
    E.1.1.1Medical condition in easily understood language
    Type 1 or type 2 diabetes mellitus and underlying asthma or COPD.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term 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
    To examine the effects of prandially inhaled TI Inhalation Powder in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents (TI Inhalation Powder group) versus antidiabetic treatment without TI Inhalation Powder (Usual Care [UC] group) on lung function and pulmonary safety in type 1 or type 2 diabetic, currently nonsmoking subjects with asthma or COPD.
    E.2.2Secondary objectives of the trial
    To compare between the treatment groups the effect of treatment on:
    • Frequency of protocol-defined nonsevere and severe asthma or COPD exacerbations
    • Acute changes in FEV1 from 15 minutes before to 15, 30, 60, and 120 minutes after TI Inhalation Powder (measured using office spirometry performed at the clinic in the TI Inhalation Powder group only)
    • Change in health-related quality of life as assessed by the St. George’s Respiratory Questionnaire (SGRQ)
    • Change in asthma control as measured by the Asthma Control Questionnaire (ACQ; for asthma subjects only)
    • Glycemic control, expressed as the percentage (%) change of glycated hemoglobin (HbA1c)
    • Incidence and frequency of defined hypoglycemia events
    • Other safety and tolerability outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria include:
    • Male and female subjects with clinical diagnoses of type 1 or 2 diabetes mellitus for ≥ 12 months and no change in their antidiabetic regimen for at least 90 days prior to screening
    • Body mass index (BMI) of < 39 kg/m2
    • HbA1c > 6.5% and ≤ 11.5%
    • Urine cotinine level ≤ 100 ng/dL

    For subjects diagnosed with asthma:
    • Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime
    • Never smoked or former smokers (≥ 6 months since cessation)
    • ≥ 18 years of age
    • Prebronchodilator FEV1 ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single-breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥ 70% predicted (Miller)
    • < 30% day-to-day variability in daily morning PEF during the 2-week run-in period
    • Significant improvement in pre- to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 mL in FEV1 or forced vital capacity [FVC]) at Screening/Visit 1 or documented significant improvement in pre- to postbronchodilator spirometry (as defined above) within past 12 months in subject’s medical records (This test must be performed only after a short-acting bronchodilator medication(s) is withheld for 6 hours and a long-acting bronchodilator medication(s) is withheld for 24 hours) or a documented positive methacholine challenge test within the past 12 months

    For subjects diagnosed with COPD:
    • Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause
    • Former smoker (≥ 6 months since cessation) with smoking history of ≥ 10 pack years
    • ≥ 40 years of age
    • Postbronchodilator FEV1/FVC ratio < 70%
    • Postbronchodilator FEV1 ≥ 50% NHANES III predicted, total lung capacity (TLC) ≥ 80% predicted ITS, and DLco (unc) ≥ 50% predicted (Miller)
    E.4Principal exclusion criteria
    • History of a pulmonary exacerbation within 8 weeks of Screening/Visit 1 (Week -4)
    • Use of systemic corticosteroids or antibiotics for a respiratory illness within 8 weeks of Screening/Visit 1 (Week -4)
    • Treatment with supplemental oxygen therapy for a respiratory illness for  2 days within the 12 months prior to Screening/Visit 1 (Week -4)
    • History of intubation or intensive care unit admission for a respiratory illness within the past 5 years
    • Greater than 2 hospitalizations or emergency room (ER) or urgent care visits requiring systemic corticosteroid treatment, or required ≥ 3 courses of systemic corticosteroids in the past 12 months for a respiratory illness
    • Clinically significant abnormal chest x-ray (in the opinion of PI or the sub-investigator) at Screening/Visit 1 (Week 4)
    • Any other clinically important pulmonary disease (eg, interstitial lung disease, cystic fibrosis, bronchiectasis, etc) confirmed by pulmonary function tests (PFTs) and/or radiological findings
    • Inability to perform pulmonary function testing that meets American Thoracic Society/European Respiratory Society (ATS/ERS) quality recommendations for acceptability or repeatability
    • Respiratory tract infection within 30 days prior to screening (subject may return 30 days after resolution of the infection for re-screening). If a subject has symptoms of a respiratory tract infection upon arrival at the clinical site for Baseline/Visit 2, the subject should be rescheduled for Visit 2, 30 days after the resolution of respiratory tract infection symptoms
    • Requires significant change (defined as initiation of a new medication or change in the dose or frequency of the controller medication) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 or between Visit 1 and Baseline/Visit 2
    • Known allergy to insulin or any of the drugs to be used in the clinical trial
    • Serum creatinine > 2.0 mg/dL (176.80 mmol/L) in males and > 1.8 mg/dL (159.12 mmol/L) in females. In subjects taking metformin, serum creatinine > 1.5 mg/dL (132.60 mmol/L) in males and > 1.4 mg/dL (123.8 mmol/L) in females
    • Evidence of serious complications of diabetes mellitus (eg, symptomatic autonomic neuropathy, advanced nephropathy, active proliferative retinopathy, severe peripheral vasculopathy)
    • Females who are pregnant or lactating or who plan to become pregnant during the clinical trial period
    • Exposure to any investigational product(s) in the past 3 months
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the comparison between the TI Inhalation Powder and UC treatment groups, with respect to change in postbronchodilator FEV1 from Screening/Visit 1 (Week -4) to Final Treatment/Visit 12 (Week 52). This will be measured at the pulmonary function laboratory (PFL).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 12 Week 52 and follow up visit at week 60
    E.5.2Secondary end point(s)
    The key secondary endpoints include comparisons between the TI Inhalation Powder and UC groups, with respect to:
    • Changes in postbronchodilator FVC and FEV1 as a percentage of forced vital capacity (FEV1/FVC), from Visit 1 to Visit 12
    • Changes in postbronchodilator TLC and DLco from Visit 1 to Visit 12
    • Incidence of protocol-defined nonsevere and severe asthma and COPD exacerbations
    • Acute change in FEV1 from 15 minutes before to 15, 30, 60, or 120 minutes after TI Inhalation Powder administration (measured at the clinic using office spirometry in the TI Inhalation Powder group only)
    • Change in SGRQ score from Baseline/Visit 2 (Week 0) to treatment Visits 6 (Week 4), 7 (Week 12), 8 (Week 20), 9 (Week 28), 10 (Week 36), 11 (Week 44), and 12 (Week 52)
    • Change in ACQ score (in asthma subjects only) from Baseline/Visit 2 (Week 0) to treatment Visits 3 (Week 1), 4 (Week 2), 5 (Week 3), 6 (Week 4) , 7 (Week 12), 8 (Week 20), 9 (Week 28), 10 (Week 36), 11 (Week 44), and 12 (Week 52).
    Other Efficacy, Safety, and Tolerability Outcomes:
    • Change in HbA1c from screening to final treatment visit
    • Incidence and severity of reported hypoglycemic events
    • Incidence and severity of reported adverse events (AE)
    • Changes from Baseline/Visit 2 (Week 0) (or Screening/Visit 1 [Week - 4] if the initial safety assessment was only performed at this visit) in vital signs and physical examinations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 12 Week 52 and follow up visit at week 60
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    antidiabetic treatment without TI inhalation powder - Usual care
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Slovakia
    Argentina
    Brazil
    Chile
    Germany
    Hungary
    United States
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.2.1Number of subjects for this age range: 459
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 510
    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 Decision2013-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-10-16
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