A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue
6. november 2018 oppdatert av: Eli Lilly and Company
Use of Open-Flow Microperfusion to Measure LY2605541 and Human Insulin Concentrations in Adipose Tissue Interstitial Fluid
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.
This study is designed to understand how the body handles the investigational drug, and to measure the quantity of LY2605541 in fat tissue.
The study has two parts.
It involves intravenous (IV) infusion of the investigational drug and a procedure to measure concentrations in the fat tissue.
Both parts of the study will be conducted in participants with type 1 diabetes mellitus (T1DM).
Part A and B of the study might take up to 7 weeks to complete.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
24
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Graz, Østerrike, 8036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
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 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment
- Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening
- Have a serum creatinine value within normal limits at screening
- Have a haemoglobin A1c (HbA1c) value ≤75 millimoles per mole (mmol/mol) (9.0%) at screening
- Have a body mass index (BMI) of 20.0-30.0 kilograms per meter squared (kg/m^2), inclusive, at screening
Exclusion Criteria:
- Have known or suspected allergies or hypersensitivities to LY2605541, human insulin, sinistrin, related compounds or any components of the formulations
- Are women who are pregnant or lactating
- Have an abnormal blood pressure for the population as determined by the investigator
- Have renal insufficiency or major renal disorders
- Have proliferative retinopathy or maculopathy
- Have lipodystrophy
- Have any wound healing disorder or are prone to keloid or hypertrophic scar formation
- Have results of screening prothrombin time (PT) and international normalized ratio (INR) tests that are significantly prolonged
- Have a fasting triglycerides value > 4.52 millimoles per liter (mmol/L) (400 milligrams/deciliter (mg/dL))
- Are receiving chronic systemic or inhaled glucocorticoid or have received such therapy within the 4 weeks before dosing
- Have a total daily insulin dose greater than 1.2 units per kilogram (U/kg)
- Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
- Regular use or intended use of non-selective beta blockers
- Regular use or intended use of monoamine oxidase (MAO) inhibitors
- Are currently participating in a weight loss program or plan to do so during the course of the study
- Are unwilling to avoid excessive sun exposure, steam baths, saunas, and swimming during the study. Sun cream should be used during sun bathing for the 6-month period following the study
- Are unwilling to avoid extensive consumption of food containing inulin during the study and in the 48-hour period leading up to the clamp
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Insulin Peglispro (LY2605541)
Part A Cohort 1: (low dose) priming dose (PD) of 2.00 units (U), 0.92 U/hour (U/h) constant infusion of insulin peglispro Part A Cohort 1: (high dose) PD of 8.00 U, 4.50 U/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 1) PD of 4.00 U, 1.84/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 2) PD of 6.0 U, 2.76 U/h constant IV infusion of insulin peglispro Part B Insulin Peglispro: PD of 6.00 U, 2.76 constant IV infusion of insulin peglispro and a constant infusion of 6 pico moles per kilogram per minute (pmol/kg/min).
IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours).
|
Administered IV
Andre navn:
|
|
Aktiv komparator: Human Insulin
Constant IV infusion ( 6 pico moles per kilogram perminute [pmol/kg/min]) of human insulin for up to 36 hours.
IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours).
|
Administered IV
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)
Tidsramme: 16, 20, 24, and 28 hours postdose
|
16, 20, 24, and 28 hours postdose
|
|
|
Part B: Pharmacokinetics: ISF-to-Serum Concentrations
Tidsramme: 16, 20, 24, and 28 hours postdose
|
Absolute concentration of ISF of insulin peglispro and human insulin.
|
16, 20, 24, and 28 hours postdose
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
1. april 2014
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. mars 2015
Datoer for studieregistrering
Først innsendt
7. april 2014
Først innsendt som oppfylte QC-kriteriene
7. april 2014
Først lagt ut (Anslag)
9. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. november 2018
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14873
- I2R-MC-BIDP (Annen identifikator: Eli Lilly and Company)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com
This access is provided in a timely fashion after the primary publication is accepted.
Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com.
Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .