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. března 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
58
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Neuss, Německo, 41460
- Novo Nordisk Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 64 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Faster aspart followed by insulin aspart
Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery
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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
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
|
|
Experimentální: Insulin aspart followed by faster aspart
Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery
|
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
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
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Continuous subcutaneous infusion related area under the insulin aspart curve, baseline corrected and based on concentrations from 0 to 30 min
Časové okno: 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
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Calculated based on insulin aspart measured in serum
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Continuous subcutaneous infusion related time from bolus to 50% of max insulin aspart concentration
Časové okno: 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
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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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
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Calculated based on glucose infusion
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Number of adverse events ( AEs)
Časové okno: Day 1-21
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Count of events
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Day 1-21
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Number of hypoglycaemic episodes
Časové okno: Day 1-21
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Count of episodes
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Day 1-21
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
3. července 2017
Primární dokončení (Aktuální)
20. listopadu 2017
Dokončení studie (Aktuální)
20. listopadu 2017
Termíny zápisu do studia
První předloženo
29. června 2017
První předloženo, které splnilo kritéria kontroly kvality
10. července 2017
První zveřejněno (Aktuální)
12. července 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. března 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. března 2019
Naposledy ověřeno
1. března 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Poruchy metabolismu glukózy
- Metabolické choroby
- Onemocnění imunitního systému
- Autoimunitní onemocnění
- Onemocnění endokrinního systému
- Diabetes Mellitus
- Diabetes mellitus, typ 1
- Hypoglykemická činidla
- Fyziologické účinky léků
- Inzulín
- Inzulin, Globin Zinek
- Inzulin Aspart
- Inzulín, dlouhodobě působící
- Inzulin degludek, kombinace léků inzulin aspart
Další identifikační čísla studie
- NN1218-4349
- 2016-004306-34 (Identifikátor registru: European Medicines Agency (EudraCT))
- U1111-1189-1545 (Jiný identifikátor: World Health Organization (WHO))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ano
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .