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A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes

28. mars 2019 oppdatert av: Novo Nordisk A/S

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

The aim of the study is to compare the pharmacokinetics (i.e. the course of the blood concentrations of the administered trial drug) of faster-acting insulin aspart (faster aspart), and the currently marketed formulation of insulin aspart (NovoRapid®) when given as a bolus using an insulin pump in people with type 1 diabetes. The pharmacodynamic response (i.e. the course of the blood sugar lowering effect of the administered trial drug) and the safety and tolerability of faster aspart and NovoRapid® will also be assessed.

The participants will be in the study for approx. 21 days. Each participant will have 5 visits to the clinic, with an overnight stay at both dosing visits. Participants will have a number of tests, and they will have to give blood and urine samples.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

58

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyskland
      • Neuss, Tyskland, 41460
        • Novo Nordisk Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 64 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female aged 18 - 64 years (both inclusive) at the time of signing informed consent.
  • Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer.
  • Body mass index 18.5 - 28.0 kg/sqm (both inclusive).
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer.

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening.
  • Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily).
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Faster aspart followed by insulin aspart
Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery
Legemiddel: Faster-acting insulin aspart
In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate
Legemiddel: Insulin aspart
In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate
Eksperimentell: Insulin aspart followed by faster aspart
Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery
Legemiddel: Faster-acting insulin aspart
In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate
Legemiddel: Insulin aspart
In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 30 min
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Continuous subcutaneous infusion related time from bolus to 50% of max insulin aspart concentration
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related time from bolus to max insulin aspart concentration
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 15 min.
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 1 hour
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 1,5 hour
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 2 hours
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to first time the curve is back to baseline
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 2 hours to first time the curve is back to baseline
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related time from bolus to late 50% of max insulin aspart concentration
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on plasma insulin measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related time from bolus to max baseline corrected insulin aspart concentration
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related time from bolus administration to 50% of max baseline corrected Glucose Infusion Rate
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Calculated based on insulin aspart measured in serum
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration measured at 56 times during 24 hours
Continuous subcutaneous infusion related time from bolus administration to max of baseline corrected Glucose Infusion Rate
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to 30 min
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to 1 hour
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to 1,5 hour
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to 2 hours
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 0 to first time the curve is back to baseline
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Continuous subcutaneous infusion related area under the glucose infusion rate curve, baseline corrected and based on concentrations from 2 hours to first time the curve is back to baseline
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Area under the glucose infusion rate curve based on concentrations from -2 to 0 hours
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Area under the glucose infusion rate curve based on concentrations from 12 to 14 hours
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Continuous subcutaneous infusion related max of baseline corrected Glucose Infusion Rate
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Continuous subcutaneous infusion related time from bolus to late 50% of max baseline corrected glucose infusion rate
Tidsramme: Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Calculated based on glucose infusion
Day of dosing: day 1 visit 2, day 1 visit 3 (7-14 days after day 2 of visit 2), based on concentration recorded approximately 57 times during 24 hours
Number of adverse events ( AEs)
Tidsramme: Day 1-21
Count of events
Day 1-21
Number of hypoglycaemic episodes
Tidsramme: Day 1-21
Count of episodes
Day 1-21

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novo Nordisk A/S

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. juli 2017

Primær fullføring (Faktiske)

20. november 2017

Studiet fullført (Faktiske)

20. november 2017

Datoer for studieregistrering

Først innsendt

29. juni 2017

Først innsendt som oppfylte QC-kriteriene

10. juli 2017

Først lagt ut (Faktiske)

12. juli 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NN1218-4349
  • 2016-004306-34 (Registeridentifikator: European Medicines Agency (EudraCT))
  • U1111-1189-1545 (Annen identifikator: World Health Organization (WHO))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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