Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
5. november 2015 opdateret af: Adocia
Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits.
At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal [(t=0 min) start of the meal].
Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region.
Subjects will be asked to consume a standardised meal (e.g.
pizza) for dinner at home in the evening before each dosing visit.
Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h).
The two dosing visits will be separated by a wash-out period of 5-15 days.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Neuss, Tyskland, 41460
- Profil Institut für Stoffwechselforschung GmbH
-
-
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:
- Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
- Treated with multiple daily insulin injections or CSII >= 12 months.
- Current total daily insulin treatment < 1.2 (I)U/kg/day.
- Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
- Usual Insulin bolus dose between 0.8 and 2 (I)U per 10 g CH (both inclusive). Expecting prandial insulin dose range for standardised meal test between 5 and 12 (I)U.
- BMI 18.5-28.0 kg/m^2 (both inclusive).
- HbA1c <= 9.0% by local laboratory analysis
- Fasting C-peptide <= 0.3 nmol/L.
Exclusion Criteria:
- Known or suspected hypersensitivity to trial products or related products.
- Type 2 diabetes mellitus.
- Previous participation in this trial. Participation is defined as randomised.
- Participation in any Clinical Trial within 3 months prior to this trial.
- Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
- Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
- Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
- Women of child bearing potential, not willing to use contraceptive methods.
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: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: BioChaperone® Combo
1 single dose 400 U/mL
|
Subcutaneous injection of an individualized dose
|
|
Aktiv komparator: Humalog® Mix25
1 single dose 100 U/mL
|
Subcutaneous injection of an individualized dose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Delta AUCBG,0-2h
Tidsramme: 2 hours
|
Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal
|
2 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Delta AUCBG,0-6h
Tidsramme: 6 hours
|
Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal
|
6 hours
|
|
BGmax
Tidsramme: 6 hours
|
Maximum blood glucose concentration after a standardised meal (0-6 hours)
|
6 hours
|
|
tBGmax
Tidsramme: 6 hours
|
Time to maximum blood glucose concentration after a standardised meal (0-6 hours)
|
6 hours
|
|
AUCLisp,0-6h,
Tidsramme: 6 hours
|
Area under the plasma insulin lispro concentration-time curve from 0-6 hours
|
6 hours
|
|
AUCGlarg,0-6h
Tidsramme: 6 hours
|
Area under the plasma insulin glargine concentration-time curve from 0-6 hours
|
6 hours
|
|
Cmax,Lisp
Tidsramme: 6 hours
|
Maximum observed plasma insulin lispro concentration
|
6 hours
|
|
Cmax,Glarg
Tidsramme: 6 hours
|
Maximum observed plasma insulin glargine concentration
|
6 hours
|
|
Adverse events
Tidsramme: Up to 7 weeks
|
Number of adverse events
|
Up to 7 weeks
|
|
Local tolerability
Tidsramme: Up to 7 weeks
|
Number and intensity of injection site reactions
|
Up to 7 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ulrike Hövelmann, MD, Profil Institut Für Stoffwechselfforschung GmbH
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 2015
Primær færdiggørelse (Faktiske)
1. november 2015
Studieafslutning (Faktiske)
1. november 2015
Datoer for studieregistrering
Først indsendt
29. juli 2015
Først indsendt, der opfyldte QC-kriterier
31. juli 2015
Først opslået (Skøn)
4. august 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BC3-CT019
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 .