- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02109029
A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue
6 november 2018 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Graz, Österrike, 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.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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).
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Administered IV
Andra namn:
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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).
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Administered IV
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)
Tidsram: 16, 20, 24, and 28 hours postdose
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16, 20, 24, and 28 hours postdose
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Part B: Pharmacokinetics: ISF-to-Serum Concentrations
Tidsram: 16, 20, 24, and 28 hours postdose
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Absolute concentration of ISF of insulin peglispro and human insulin.
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16, 20, 24, and 28 hours postdose
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2014
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 mars 2015
Studieregistreringsdatum
Först inskickad
7 april 2014
Först inskickad som uppfyllde QC-kriterierna
7 april 2014
Första postat (Uppskatta)
9 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 mars 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 november 2018
Senast verifierad
1 november 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14873
- I2R-MC-BIDP (Annan identifierare: Eli Lilly and Company)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .