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Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake

21. oktober 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Santa Barbara, California, Forenede Stater, 93105
        • Sansum Medical Research Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: TI Inhalation Powder (original protocol)
Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics
Andet: 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.
Medicin: TI Inhalation Powder and Humalog (Amendment 1)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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 Excursion - Original Protocol (TI Treated Type 1 Subjects)
Tidsramme: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
0 to 240 minutes
Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
Tidsramme: 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)
Tidsramme: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
0 to 240 minutes
Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)
Tidsramme: 0 to 240 minutes
Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
0 to 240 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Tidsramme: 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
Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Tidsramme: 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
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Tidsramme: 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
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mannkind Corporation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2008

Primær færdiggørelse (Faktiske)

1. februar 2011

Studieafslutning (Faktiske)

1. maj 2011

Datoer for studieregistrering

Først indsendt

3. september 2008

Først indsendt, der opfyldte QC-kriterier

3. september 2008

Først opslået (Skøn)

4. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MKC-TI-119

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