Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake
21 oktober 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
18
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
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Santa Barbara, California, Förenta staterna, 93105
- Sansum Medical Research Institute
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Tidsram: 0 to 240 minutes
|
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
|
|
Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Tidsram: 0 to 240 minutes
|
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
|
|
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Tidsram: 0 to 240 minutes
|
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
|
|
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Tidsram: 0 to 240 minutes
|
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)
Tidsram: 0 to 240 minutes
|
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
|
0 to 240 minutes
|
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Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
Tidsram: 0 to 240 minutes
|
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast
|
0 to 240 minutes
|
|
Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)
Tidsram: 0 to 240 minutes
|
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)
Tidsram: 0 to 240 minutes
|
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
|
0 to 240 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Tidsram: 0 to 240 minutes
|
Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch
|
0 to 240 minutes
|
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Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Tidsram: 0 to 240 minutes
|
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)
Tidsram: 0 to 240 minutes
|
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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Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Tidsram: 0 to 240 minutes
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2008
Primärt slutförande (Faktisk)
1 februari 2011
Avslutad studie (Faktisk)
1 maj 2011
Studieregistreringsdatum
Först inskickad
3 september 2008
Först inskickad som uppfyllde QC-kriterierna
3 september 2008
Första postat (Uppskatta)
4 september 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 oktober 2014
Senast verifierad
1 oktober 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Luftvägssjukdomar
- Immunsystemets sjukdomar
- Autoimmuna sjukdomar
- Andningsstörningar
- Sjukdomar i det endokrina systemet
- Diabetes mellitus
- Diabetes mellitus, typ 2
- Diabetes mellitus, typ 1
- Andningsaspiration
- Hypoglykemiska medel
- Läkemedels fysiologiska effekter
- Insulin Lispro
Andra studie-ID-nummer
- MKC-TI-119
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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