Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake
21 octobre 2014 mis à jour par: Mannkind Corporation
A Phase 2, Single-Center, Open-Label, Pharmacodynamic Clinical Trial to Evaluate the Effect of Technosphere® Insulin Inhalation Powder Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Postprandial Glucose Levels in Subjects With Type 1 and Type 2 Diabetes Mellitus Ingesting Meals With Varied Carbohydrate Content
The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content.
Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%).
The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.
Aperçu de l'étude
Statut
Résilié
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
18
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Santa Barbara, California, États-Unis, 93105
- Sansum Medical Research Institute
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Clinical diagnoses of type 1 or type 2 diabetes mellitus
- Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) > 6.5% and < or = 10.0%.
- Body mass index (BMI) of < or = 40 kg/m2
- Non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dL
- Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70%
- For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment
Exclusion Criteria:
- History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (PFT) and/or radiologic findings
- Elevated liver function test (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
- Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks
- Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
- Exposure to any investigational product(s) in the past 12 weeks
- For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: TI Inhalation Powder (original protocol)
Under the original protocol, subjects with Type 1 and Type 2 diabetes will have TI Inhalation Powder administered prandially during dose optimization visits and meal challenge visits (with meals of varying carbohydrate contents).
Subjects with Type 2 diabetes will also use TI Inhalation Powder daily at each meal between visits.
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Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics
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Autre: TI Inhalation Powder and Humalog (Amendment 1)
Under Amendment 1, TI Inhalation Powder will be administered prandially to a new subset of subjects with Type 2 diabetes during TI dose optimization visits and TI meal challenge visits (with meals of varying carbohydrate contents).
Subjects will be crossed over to administration of Humalog 15 minutes before meals during Humalog dose optimization visits and Humalog meal challenge visits (with meals of varying carbohydrate contents).
Subjects will also use TI Inhalation Powder daily at each meal between visits.
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Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal.
Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Délai: 0 to 240 minutes
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AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC |
0 to 240 minutes
|
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Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Délai: 0 to 240 minutes
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AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC |
0 to 240 minutes
|
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Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Délai: 0 to 240 minutes
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AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC |
0 to 240 minutes
|
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Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Délai: 0 to 240 minutes
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AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC |
0 to 240 minutes
|
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Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)
Délai: 0 to 240 minutes
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Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
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0 to 240 minutes
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Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
Délai: 0 to 240 minutes
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Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast
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0 to 240 minutes
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Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)
Délai: 0 to 240 minutes
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Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
|
0 to 240 minutes
|
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Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)
Délai: 0 to 240 minutes
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Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
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0 to 240 minutes
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Délai: 0 to 240 minutes
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Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch
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0 to 240 minutes
|
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Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Délai: 0 to 240 minutes
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Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast
|
0 to 240 minutes
|
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Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Délai: 0 to 240 minutes
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Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
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0 to 240 minutes
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Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Délai: 0 to 240 minutes
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Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
|
0 to 240 minutes
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2008
Achèvement primaire (Réel)
1 février 2011
Achèvement de l'étude (Réel)
1 mai 2011
Dates d'inscription aux études
Première soumission
3 septembre 2008
Première soumission répondant aux critères de contrôle qualité
3 septembre 2008
Première publication (Estimation)
4 septembre 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 octobre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 octobre 2014
Dernière vérification
1 octobre 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies des voies respiratoires
- Maladies du système immunitaire
- Maladies auto-immunes
- Troubles respiratoires
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Diabète sucré, type 1
- Aspiration respiratoire
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Insuline Lispro
Autres numéros d'identification d'étude
- MKC-TI-119
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .