Página Nct de ensaios clínicos

Summary
EudraCT Number:2006-002245-36
Sponsor's Protocol Code Number:MKC-TI-103
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2007-02-06
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2006-002245-36
A.3Full title of the trial
Ensayo en fase 3, multicéntrico, abierto, aleatorizado y controlado de 24 semanas para comparar la eficacia y la seguridad de la inhalación prandial de Technosphere®/Insulina en combinación con metformina o Technosphere®/Insulina en monoterapia frente a dos antidiabéticos orales (metformina y un secretagogo) en sujetos con diabetes mellitus tipo 2 controlada de forma subóptima con la combinación de metformina y un secretagogo

A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere®/Insulin in Combination with Metformin or Technosphere®/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-Optimally Controlled on Combination Metformin and a Secretagogue
A.3.2Name or abbreviated title of the trial where available
OPTION
A.4.1Sponsor's protocol code numberMKC-TI-103
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®/Insulina
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 INNInsulina Humana rDNA
D.3.9.1CAS number 11061-68-0
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 Yes
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 typeTerapia hormonal sustitutiva
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 El paciente entrará en el ensayo con la Metformina que él esté tomando en ese momento
D.2.1.1.2Name of the Marketing Authorisation holderVarios
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 nameMetformina
D.3.2Product code NA
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNMetformina HCL
D.3.9.1CAS number 1115-70-4
D.3.9.2Current sponsor codeNA
D.3.9.3Other descriptive nameNA
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typerange
D.3.10.3Concentration number500 to 1000
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.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 El paciente entrará en el ensayo con la sulfonamidas, derivados de la urea que él esté tomando en ese momento
D.2.1.1.2Name of the Marketing Authorisation holderVarios
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 nameSulfonamidas, derivados de la urea
D.3.2Product code NA
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGliclazida
D.3.9.1CAS number 21187-96-4
D.3.10 Strength
D.3.10.1Concentration unit IU/mg international unit(s)/milligram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNGlimepirida
D.3.9.1CAS number 93479-97-1
D.3.10 Strength
D.3.10.1Concentration unit IU/mg international unit(s)/milligram
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 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.IMP: 4
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 El paciente entrará en el estudio con la meglitinida que él esté tomando en ese momento
D.2.1.1.2Name of the Marketing Authorisation holderVarios
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 nameMeglitinida
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNRepaglinida
D.3.9.1CAS number 135062-02-1
D.3.10 Strength
D.3.10.1Concentration unit IU/mg international unit(s)/milligram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNateglinida
D.3.9.1CAS number 105816-04-4
D.3.10 Strength
D.3.10.1Concentration unit IU/mg international unit(s)/milligram
D.3.10.2Concentration typerange
D.3.10.3Concentration number60 to 180
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
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Diabetes mellitus tipo II controlada de forma subóptima con la combinación de metformina y un secretagogo

Type II diabetes Mellitus sub-optimally controlled on combination Metformin and a secretagogue.
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
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
Demostrar la eficacia de T/I prandial inhalada en combinación con metformina frente a la combinación de metformina y un secretagogo (sulfonilurea o meglitinida) en sujetos con diabetes mellitus tipo 2 controlada de forma subóptima.
E.2.2Secondary objectives of the trial
Evaluar:
- Eficacia de Tecnosphere/Insulina (T/I) prandial inhalada en monoterapia frente a la combinación de metformina y un secretagogo (sulfonilurea o meglitinida);
- Efecto de T/I prandial inhalada sobre las variaciones de la glucosa postpandrial (GPP) después de la ingestión de una comida líquida normalizada (estimulación por ingesta);
- Efecto de T/I prandial inhalada sobre la proporción de sujetos que alcancen los objetivos predefinidos de control de la glucemia;
- Efecto de T/I prandial inhalada sobre la CdV y la satisfacción con el tratamiento;
- Seguridad de T/I prandial inhalada, expresada como la incidencia de hipoglucemia, AA pulmonares y de otros tipos y cambios de la función respiratoria
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Varones y mujeres ≥ 18 y ≤ 80 años de edad, no fumadores; con diagnóstico clínico de diabetes mellitus tipo 2 durante ≥ 6 meses;
- Régimen estable de metformina ≥ 1.000 mg/día (o dosis tolerada máxima) y un secretagogo (sulfonilurea o meglitinida) ≥ ½ la dosis diaria máxima recomendada por el fabricante (o dosis tolerada máxima) sin ajustes de dosis, marca o formulación (es decir, liberación inmediata o prolongada) durante las 6 semanas precedentes. Las combinaciones en dosis fijas de metformina y sulfonilurea serán aceptables siempre que cada dosis cumpla los criterios de inclusión.
- HbA1c ≥ 7,5% y ≤ 11,0%;
-IMC ≤ 40 kg/m2;
-Pruebas de función respiratoria (PFR):
* FEV1 ≥ 70% con respecto al valor teórico NHANES III;
* TLC ≥ 80% con respecto al valor teórico (ITS);
* DLco (unc) ≥ 80% con respecto al valor teórico (Miller);
E.4Principal exclusion criteria
- Tratamiento con cualquier tipo de tratamiento antidiabético, distinto de metformina y secretagogos (sulfonilureas o meglitinida), durante las 12 semanas precedentes;
- creatinina sérica > 1,5 mg/dl en los varones y > 1,4 mg/dl en las mujeres
-Historia de enfermedad pulmonar obstructiva crónica (EPOC), asma clínicamente probado y/o otra enfermedad pulmonar clínicamente significativa confirmada por las pruebas de función respiratoria y/o hallazgos radiológicos
-Evidencia de complicaciones graves de diabetes( p.e.neuropatía autonómica)
E.5 End points
E.5.1Primary end point(s)
La variable principal de eficacia es una comparación de la variación media entre el período basal y la semana 12 de los valores de HbA1c entre los sujetos tratados con T/I en combinación con metformina (grupo 3) (evaluado) y el grupo tratado con la combinación de metformina y secretagogo (control).
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 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 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 concerned5
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA28
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 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
30 días después de la última visita del último paciente
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 state70
F.4.2 For a multinational trial
F.4.2.1In the EEA 210
F.4.2.2In the whole clinical trial 525
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 Decision2007-02-06
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-09-20
P. End of Trial
P.End of Trial StatusOngoing

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