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Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling

21. november 2019 opdateret af: Steven J. Russell, MD, PhD, Massachusetts General Hospital

The investigators are doing this research study to compare the pharmacokinetics (PK) (rate of absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine (Apidra) within individual subjects.

Additionally, the investigators will perform a preliminary feasibility evaluation of a minimally invasive continuous insulin monitoring (CIM) device and its use to derive PK parameters in human subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

33

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older with clinical type 1 diabetes for at least five years
  • Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra).
  • Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 9 units of rapid acting insulin

Exclusion Criteria:

  • Unable to provide informed consent
  • Unable to comply with study procedures
  • Inadequate venous access as determined by study nurse or physician at time of screening.
  • Pregnancy
  • History of gastric banding, gastric bypass, or other gastrointestinal condition that may prevent a subject from consuming a normal sized meal
  • Hemoglobin <13.5 for men, < 12 for women

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Multiplex pharmacokinetic profiling
Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin. All subjects participated in the single study arm and received injections of each type of insulin. Blood samples were drawn at intervals for pharmacokinetic profiling.
Andet: Multiplex pharmacokinetic profiling
Eksperimentel: Continuous insulin monitoring
Continuous insulin monitoring (CIM) of insulin lispro. Some subjects participated in the CIM sub-study, which is distinct from the Multiplex Pharmacokinetic Profiling study. This intervention involved administering insulin lispro and monitoring pharmacokinetic profile of the drug using blood samples and an investigational continuous insulin monitoring system.
Andet: Continuous insulin monitoring

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
For Multiplex PK Profiling: Aggregate Mean Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax for Individuals
Tidsramme: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose
The average difference in tmax between lispro and aspart in all participants
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose
For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin
Tidsramme: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual
Tidsramme: Baseline
Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average A1c for each of the three categories is reported.
Baseline
Multiplex PK: Count of Subjects With Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax That is > 25%
Tidsramme: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose
Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog With Tmax < 60 Minutes vs. Use of an Insulin Analog With Tmax > 60 Minutes for Each Individual
Tidsramme: Baseline
Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with tmax less than or equal to 60 minutes or using insulin with tmax > 60 minutes. The average A1c per group is reported.
Baseline
Multiplex PK: Average Number of Hypoglycemia Events Over the Last Month at Baseline Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual
Tidsramme: 1 month prior to study entry
Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average number of hypoglycemic events per month per group is reported.
1 month prior to study entry

Samarbejdspartnere og efterforskere

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

Sponsor

Massachusetts General Hospital

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. juli 2010

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. december 2017

Datoer for studieregistrering

Først indsendt

21. august 2012

Først indsendt, der opfyldte QC-kriterier

10. september 2012

Først opslået (Skøn)

13. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010P001005

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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