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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   40995   clinical trials with a EudraCT protocol, of which   6701   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2006-004421-28
    Sponsor's Protocol Code Number:A2171084
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-24
    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 ConcernedFinland - Fimea
    A.2EudraCT number2006-004421-28
    A.3Full title of the trial
    A SIX MONTH, OPEN-LABEL OUTPATIENT, RANDOMIZED PARALLEL GROUP TRIAL ASSESSING THE IMPACT OF DRY POWDER INHALED INSULIN (EXUBERA®) ON GLYCEMIC CONTROL COMPARED TO INSULIN GLARGINE (LANTUS®) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE POORLY CONTROLLED ON A COMBINATION OF TWO OR MORE ORAL AGENTS
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA2171084
    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 Oy
    B.1.3.4CountryFinland
    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 Ltd
    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 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.3.9.1CAS number 11061-68-0
    D.3.9.3Other descriptive nameCP 464005
    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 Ltd
    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 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.3.9.1CAS number 11061-68-0
    D.3.9.3Other descriptive nameCP 464005
    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.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 Lantus®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland Gmbh
    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.3.8INN - Proposed INNInsulin glargine
    D.3.9.1CAS number 160337-95-1
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international 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 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
    Diabetes Mellitus type II (not insulin independent)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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 of the study is to demonstrate non-inferiority of dry powder inhaled insulin (Exubera®) compared to insulin Glargine (Lantus®) in terms of glycemic control (HbA1c) after 26 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are to demonstrate superiority of inhaled insulin over insulin Glargine on the following endpoints: change of fasting glucose and postprandial glucose excursions from baseline to end of the treatment period, the percentage of subjects who have an HbA1c of less than 6.5%, 7.0%, or 8.0% at
    the end of the treatment period, rates of overall and nocturnal hypoglycemia, changes in body weight and BMI, glucose excursions over 24 hours in a subset of subjects, and patient reported outcomes at week 26 compared to baseline. Additional secondary objectives are changes in urinary free 8 iso-prostaglandin F2α in a subset of patients, high sensitive C-reactive protein, interleukin 6 (IL-6), thrombin-antithrombin complexes (tat-complexes), and soluble tissue factor from baseline to end of the treatment period.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Exploratory 24-hour Glucose In-patient Substudy, 29th August, 2006
    Substudy Objectives:
    This is an exploratory study designed to assess the impact of treatment with Exubera or insulin glargine on various indices of glycemic stability over 24 hours and collect limited pharmacokinetic data.

    2. Exploratory Urinary 8-iso Prostanes Substudy, 29th August, 2006
    Title:
    A comparison of mealtime inhaled insulin vs. subcutaneous basal insulin on glucose fluctuations and activation of oxidative stress as assessed by urinary 8-iso PGF2α in type 2 diabetes patients
    Substudy Objectives:
    The primary objective of this substudy is to explore whether pre-meal inhaled insulin (Exubera) results in less oxidative stress, as measured by urinary excretion of 8-iso PGF2α per 24 hour in type 2 diabetes patients failing on oral medication, compared to SC insulin glargine and whether differences are mediated by reduced glucose fluctuations, as measured by Mean Amplitude of Glycemic Excursions (MAGE) derived from 8 points blood glucose profiles taken concomitantly with the urine collection and during 24 hour continuous glucose monitoring in the exploratory subgroup.

    Secondary aims are to investigate the relation between baseline demographic data, glycemic excursions as per parameters described in the master protocol, and oxidative stress.

    E.3Principal inclusion criteria
    Male and female subjects meeting all of the following criteria will be considered for enrollment into the study.
    1. Age ≥ 30 years with a diagnosis of type 2 diabetes mellitus made ≥ 6 months prior to study entry, as defined by the American Diabetes Association (Diabetes Care 25: S5-S20, 2002).
    2. Screening HbA1c ≥ 7.0%
    3. Currently treated on a stable dose of at least 2 oral hypoglycemic agents which must include combinations of sulfonylureas and metformin for at least 3 months prior to study entry. If a subject on a non-sulfonylurea secretagogue can be switched to glimepiride 2 mg at visit 2, they may be screened. Treatment with thiazolidinediones is permitted in addition to the sulfonylurea and metformin where concurrent treatment with insulin is permitted.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. Patients with Type 1 diabetes mellitus as defined by ADA.
    2. Patients with type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (only or associated to oral hypoglycemic agents (OHAs).
    3. Patients with type 2 diabetes mellitus who are treated with thiazolidinediones where per local regulation concurrent use of insulin with thiazolidinediones is prohibited.
    4. Patients taking any of the following hypoglycemic agents or agents within the following classes of drugs: repaglinide, nateglinide, exenatide, and dipeptidyl peptidase-4 inhibitors such as vildagliptin; rosiglitazone and pioglitazone where concurrent use of these agents with insulin is not permitted.
    5. Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, ALAT (SGPT) or ASAT (SGOT) above 2x the upper limit of normal as measured at visit 1.
    However, patients with elevated ALT >1.5 UNL as a result of hepatic steatosis are permitted to enter the study.
    6. Significant kidney disease:
    a. History of renal transplantation or current renal dialysis or
    b. Serum creatinine > 1.5 mg/dl (≥ 133 µmol/L) in males and > 1.4 mg/dl (≥ 124 µmol/L) in females and/or BUN > 50 mg/dl or
    c. Urinary albumin/creatinine ratio >2.5 mg/mmol in men and >3.5 mg/mmol in women or
    d. Clinical nephrotic syndrome
    7. Any other clinically significant abnormalities on screening laboratory evaluation (unless discussed with the monitor and approved by the study management).
    8. Patients who do not have documentation of an ophthalmologic exam performed in the 12 months prior to visit 1 in accordance with local guidelines.
    9. Active proliferative diabetic retinopathy, as defined by the application of focal or pan retinal photocoagulation or vitrectomy, in the 12 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study.
    10. Donation of blood or transfusion during the 2 months prior to visit 1.
    11. Pregnant or lactating women, or females of child-potential who are unwilling or unable to use adequate contraception to prevent pregnancy during the study.
    12. Treatment with any investigational drug including inhaled insulin in the 3 months prior to visit 1 (screening).
    13. Significant pulmonary diseases including:
    o FEV1 <70% of predicted.
    o History of moderate or severe asthma including those with daily symptoms and/or
    require daily use of inhaled short acting beta2-agonist.
    o History of moderate or severe COPD including those requiring regular use of one
    or more bronchodilators (beta2-agonists, anticholinergics, methylxanthines).
    However, short acting bronchodilators used as needed are allowed.Poorly controlled asthma, clinically significant obstructive pulmonary disease or other significant respiratory disease.
    14. Smoking within the last 6 months prior to the study. Smoking is not permitted at any time during this study.
    15. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
    16. Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult. However, wellcontrolled, stable disorders and complications directly related to diabetes (such as peripheral neuropathy, mild nephropathy or retinopathy) would not exclude a patient.
    17. Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
    18. History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse.
    19. Night shift workers.
    20. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
    21. Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
    22. Subject is not willing and able to perform specified home blood glucose (HBGM) monitoring and to otherwise comply with study protocol requirements.
    23. Subject who has not signed and dated informed consent prior to any study procedures.
    24. Patients with contraindications according to the local prescribing information of sulfonylureas, Metformin, thiazolidinediones (where concurrent treatment with insulin is permitted), Exubera and Lantus
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline to HbA1c measured at week 26 (approx. 6 months) after treatment.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient reported outcomes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 413
    F.4.2.2In the whole clinical trial 478
    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 Decision2007-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-12
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