- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02964104
A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes
23. august 2021 opdateret af: Novo Nordisk A/S
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Subjects With Type 2 Diabetes
This trial is conducted in Europe.
The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects with type 2 diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Neuss, Tyskland, 41460
- Novo Nordisk Investigational Site
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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 64 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent.
- Subject who is considered to be generally healthy (with the exception of conditions associated with diabetes mellitus), based on the medical history, physical examination, and the results of vital signs, ECG and laboratory safety tests, as judged by the investigator.
- Body mass index between 20.0 and 34.9 kg/m^2 (both inclusive).
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥12 months (365 days).
- No change in insulin treatment regimen during the last 90 days prior to screening.
- Current total daily insulin treatment between 0.3 and 1.0 (I) U/kg/day (both inclusive).
Exclusion Criteria:
- Known or suspected hypersensitivity to trial products or related products.
- Female who is pregnant, breast-feeding, or intending to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by regulation or practice)(highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation,hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner). Females who are not postmenopausal can participate in the study if they use adequate contraceptive methods. Postmenopausal is defined as women aged <52 years and being amenorrheic for more than one year with serum follicle stimulating hormone (FSH level >40 IU/L or aged ≥ 52 years and being amenorrheic for less than one year and with serum FSH level > 40 IU/L or aged ≥ 52 years being amenorrheic for more than one year.
- Receipt of any investigational medicinal product within 3 months before the screening visit of this trial.
- History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator.
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days.
- Use of oral antidiabetic drugs (OADs) or GLP-1 receptor agonists (e.g. exenatide, liraglutide) within 3 months prior to screening.
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: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Insulin 287 + placebo
Each dose group will consist of 16 subjects randomised for once-weekly s.c.
(subcutaneous, under the skin) administration of insulin 287 and once daily s.c.
placebo (n=12) or once-weekly s.c.
placebo and once daily s.c.
insulin degludec (n=4)
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Administered once weekly subcutaneously (s.c., under the skin) for 35 days
Andre navne:
Administered once daily subcutaneously for 35 days
Administered once weekly subcutaneously for 35 days
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Aktiv komparator: Insulin degludec + placebo
Each dose group will consist of 16 subjects randomised for once-weekly s.c.
(subcutaneous, under the skin) administration of insulin 287 and once daily s.c.
placebo (n=12) or once-weekly s.c.
placebo and once daily s.c.
insulin degludec (n=4)
|
Administered once daily subcutaneously for 35 days
Administered once weekly subcutaneously for 35 days
Administered once daily subcutaneously for 35 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of treatment emergent adverse events (TEAE)
Tidsramme: From the first trial product administration at day 1 until completion of the post-treatment follow-up visit (day 68 - 79)
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From the first trial product administration at day 1 until completion of the post-treatment follow-up visit (day 68 - 79)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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AUCI287,τ,SS, area under the steady-state serum insulin 287 concentration-time curve
Tidsramme: During one dosing interval at steady-state from 0 to 168 hours after last dose (day 29)
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During one dosing interval at steady-state from 0 to 168 hours after last dose (day 29)
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AUCGIR,0-24h,SS, area under the glucose infusion rate-time curve at steady state
Tidsramme: At day 30 and day 35
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At day 30 and day 35
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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 (Faktiske)
15. november 2016
Primær færdiggørelse (Faktiske)
12. december 2017
Studieafslutning (Faktiske)
12. december 2017
Datoer for studieregistrering
Først indsendt
11. november 2016
Først indsendt, der opfyldte QC-kriterier
11. november 2016
Først opslået (Skøn)
15. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN1436-4314
- 2016-000436-18 (EudraCT nummer)
- U1111-1178-9795 (Anden identifikator: World Health Organization)
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 .