A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
28. april 2016 opdateret af: Adocia
A Randomised, Monocentric, Double-blind, Multiple Daily Dose, Two-period 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualised Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days.
Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro.
Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14.
Insulin doses will be determined at the screening visit.
During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason).
They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime).
In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
51
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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Mainz, Tyskland, 44116
- Profil Mainz GmbH & Co.KG
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Neuss, Tyskland, 41460
- Profil GmbH
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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 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes mellitus ≥ 12 months
- Treated with stable multiple daily insulin ≥ 3 months (basal-bolus therapy or only bolus insulin therapy)
- Current total daily insulin treatment <1.2 (I)U/kg/day
- Body Mass Index below or equal to 40.0 kg/m²
- HbA1c ≤ 9.0% by local laboratory analysis
Exclusion Criteria:
- Known or suspected hypersensitivity to trial products or related products
- Type 1 diabetes mellitus
- Previous participation in this trial
- The receipt of any investigational product within 60 days 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
- Presence of renal impairment (Estimated Glomerular filtration Rate (eGFR)<60 milliliters/minute/1.73m²)
- Presence of late diabetic complications and/or acute coronary heart disease.
- 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
- Current treatment with corticosteroids
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 |
|---|---|
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Aktiv komparator: Humalog®
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Injection immediately before the start of the individualised standard meal
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Eksperimentel: BioChaperone insulin lispro
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Injection immediately before the start of the individualised standard meal
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pharmacodynamics: ΔAUCBG 0-2h
Tidsramme: 2 hours
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Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro)
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2 hours
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Pharmacokinetics: AUClis 0-30min
Tidsramme: 30 minutes
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Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro)
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30 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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AUClisp_0-6h
Tidsramme: up to 6 hours
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Area Under the serum insulin Lispro concentration-time Curve from 0-6 hours after bolus dose
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up to 6 hours
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Cmax_lisp
Tidsramme: up to 6 hours
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Maximum serum insulin lispro Concentration
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up to 6 hours
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tmax_lisp
Tidsramme: up to 6 hours
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Time to maximum observed serum insulin lispro concentration
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up to 6 hours
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CmaxBG
Tidsramme: up to 6 hours
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Maximum Blood Glucose after an individualised standard meal
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up to 6 hours
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AUCBG_0-6h
Tidsramme: up to 6 hours
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Area Under the Curve under the Blood Glucose concentration time curve from 0-6 hours
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up to 6 hours
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Adverse Events
Tidsramme: up to 8 weeks
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Number of Adverse Events
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up to 8 weeks
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Local tolerability
Tidsramme: up to 8 weeks
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Record of injection site reaction
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up to 8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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. september 2015
Primær færdiggørelse (Faktiske)
1. januar 2016
Studieafslutning (Faktiske)
1. januar 2016
Datoer for studieregistrering
Først indsendt
28. september 2015
Først indsendt, der opfyldte QC-kriterier
28. september 2015
Først opslået (Skøn)
29. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BC3-CT014
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