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    Summary
    EudraCT Number:2005-003504-11
    Sponsor's Protocol Code Number:A2171063
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-12-13
    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 number2005-003504-11
    A.3Full title of the trial
    A six-month, open-label outpatient, parallel group trial assessing the impact of inhaled insulin (Exubera®) on glycemic control in patients with type 2 diabetes mellitus who are poorly controlled on two oral anti-diabetic agents.
    A.3.2Name or abbreviated title of the trial where available
    EXACTA
    A.4.1Sponsor's protocol code numberA2171063
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorPfizer AB
    B.1.3.4CountrySweden
    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 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 nameInsulin Dry Powder Pulmonary Inhaler (Exubera®)
    D.3.2Product code CP-464,005
    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
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 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 nameInsulin Dry Powder Pulmonary Inhaler (Exubera®)
    D.3.2Product code CP-464,005
    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
    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 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 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 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 is to compare the efficacy between subjects who are treated with the combination of OHA’s and Exubera® compared to subjects treated with usual diabetes care, by looking at the mean reduction in HbA1c after 24 weeks in both groups.
    E.2.2Secondary objectives of the trial
    The secondary objective is to further explore the efficacy, safety and humanistic impact by evaluating the following secondary endpoints:
    •Proportion of subjects achieving good glycemic control (HbA1c ≤6.5% and ≤7.0%).
    •Time to achieve glycemic control (HbA1c ≤6.5% and HbA1c ≤7.0%).
    •Change from baseline to end of treatment in fasting plasma glucose (FPG) level.
    •Time course of change in fasting plasma glucose levels.
    •Incidence and severity of hypoglycemia.
    •Change from baseline to end of treatment in body weight and body mass index.
    •Change from baseline to end of treatment in fasting lipid profile.
    •Number of subjects who require additional treatment 12 weeks after randomization.
    •Number of subjects who discontinue due to insufficient clinical response.
    •Change from baseline to end of treatment in pulmonary forced expiratory volume in one second (FEV1).
    •Incidence and severity of clinical adverse events.
    •Subject reported treatment satisfaction and health status.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has given written informed consent to participate in the study.
    2. Age ≥35 years and ≤80 years with a diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association (Diabetes Care 25: S5-S20, 2002)made at least 6 months prior to screening.
    3. Has a screening HbA1c ≥8% and ≤11.0%.
    4. Has a Body Mass Index (BMI) ≥23 kg/m 2 and ≤40 kg/m 2 , calculated using the following formula
    BMI = Weight in Kilograms
    (Height in Meters) x (Height in Meters)

    or

    BMI = ( Weight in Kilograms ) x 10,000
    (Height in centimeters) x (Height in centimeters)

    5. Is currently treated and on a stable dose of two OHA’s for at least 3 months prior to study entry.
    6. Has documentation of a full ophthalmologic exam (including fundoscopy) by an ophthalmologist within 6 months prior to randomization.
    7. Is willing and able to perform specified home blood glucose monitoring (HBGM) and to otherwise comply with study protocol requirements.
    8. Has the ability to understand the requirements of the study.
    E.4Principal exclusion criteria
    1. Has Type 1 Diabetes mellitus as defined by American Diabetes Association (ADA) criteria.
    2. Has Type 2 diabetes chronically treated with insulin regimen (only, or in combination with OHA’s).
    3. Has Type 2 diabetes and is not treated with OHA or treated with only one OHA, or those treated with OHA’s that are prohibited for use in combination with other OHA’s or with insulin as per country specific labeling requirements for such agents.
    4. Is currently treated with TZD’s. Subject will be allowed to enter the study after a 12-week wash out period.
    5. Has a known allergy to insulin.
    6. Has a "brittle" diabetes or a predisposition to severe hypoglycemia
    7. Has any of the following metabolic conditions:
    •Significant hypoglycemia risk e.g., history of >2 severe (as defined by DCCT) hypoglycemic episodes within past 6 months
    •Known adrenal insufficiency
    •Symptomatic autonomic neuropathy and/or
    •Current chronic systemic corticosteroid treatment likely to be of metabolic effect
    (prednisone equivalent >2 mg/day); intercurrent treatment at a higher dose is allowed if treatment duration does not exceed 2 weeks. Corticosteroids given topically and as intra-articular injections are allowed during the course of the trial
    8. Has an impaired hepatic function, as shown by, but not limited to, ALT (SGPT) or AST (SGOT) above 2x the upper limit of normal as measured at visit 1.
    9. Has an impaired renal function, as shown by, but not limited to, serum creatinine >177 µmol/l (>2 mg/dl) as measured at visit 1 or current renal dialysis.
    10. Has any other clinically significant abnormalities on screening laboratory evaluation
    11. Has hemoglobinopathy or chronic anemia or any other condition known to interfere with HbA1c determination.
    12. Has active proliferative diabetic retinopathy
    13. Has donated blood or had a transfusion of blood/blood products during the trial and 2 months prior to screening.
    14. If the subject is female who is pregnant, lactating or planning to become pregnant during the study.
    15. Has any of the following pulmonary conditions:
    •Frankly abnormal FEV1 at Week –4, defined as FEV1 <70% of predicted.
    •Clinically significant abnormalities on screening chest X-ray (or chest MRI).
    16. Is unable to perform assessment of FEV1 according to predefined quality criteria following American Thoracic Society (ATS) or local country specific guidelines.
    17. Has smoked within the last 6 months prior to entry in the study. Smoking is not permitted at any time during this study.
    18. Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.
    19. Has any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases which, in the investigator’s opinion, make implementation of the protocol or interpretation of the study results difficult. Well controlled, stable disorders such as essential hypertension and complications directly related to diabetes (such as peripheral neuropathy, mild nephropathy or stable retinopathy) would not exclude a subject.
    20. Has an active infection (e.g., HIV, hepatitis), or a history of severe infection, during the 30 days prior to screening.
    21. Is being treated or likely to require treatment during the study period with drugs not permitted by the clinical study protocol.
    22. Has participatied in any other studies involving investigational or marketed products within the two (2) months prior to entry in the study.
    23. Has participated in any prior Exubera® or other inhaled insulin clinical trials.
    24. Has a history of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse.
    25. Has any current malignancy except:
    a. Those ≥5 years ago without recurrence.
    b. Excised basal cell carcinoma or squamous cell cancer.
    26. Is a night shift workers.
    27. Is unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, or is unlikely to complete the study.
    28. Is an investigator, sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Diabetes–related Endpoints :
    The primary efficacy endpoint will be change from baseline in HbA1c at the end of the treatment period. Secondary endpoints include the percentage of subjects who have an HbA1c of ≤7% and ≤6.5% at the end of the treatment period, rates of hypoglycemia, changes in body weight at week 24 compared to baseline, time to achieve good control - an HbA1c of ≤7% and ≤6.5%.

    Safety Endpoints:
    Clinical laboratory tests, pulmonary and liver function tests, vital signs and clinical adverse events including hypoglycemia will be evaluated.
    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 Yes
    E.6.4Safety Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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 years0
    E.8.9.1In the Member State concerned months20
    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 months20
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-13. Yes
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 432
    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 Decision2006-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-10-26
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