- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01600950
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
3. oktober 2014 opdateret af: Eli Lilly and Company
Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes.
Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time.
There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy.
The duration of this study can be up to 9.5 weeks.
The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
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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Neuss, Tyskland, 41460
- 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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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 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
- have had a duration of diabetes ≥1 year
- have hemoglobin A1c ≤10.0%
- have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
- have a body mass index ≤29 kilograms per square meter (kg/m²)
- have venous access sufficient to allow blood sampling and cannulation for clamp procedures
Exclusion Criteria:
- are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
- have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
- have a history of proliferative retinopathy
- have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
- have an electrocardiogram (ECG) reading considered outside the normal limits
- have an abnormal blood pressure
- have abnormal clinical laboratory tests
- have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
- show evidence of significant active neuropsychiatric disease
- regular use of known drugs of abuse and/or show positive findings on drug screening
- show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
- show evidence of hepatitis C and/or positive hepatitis C antibody
- show evidence of hepatitis B and/or positive hepatitis B surface antigen
- are women with a positive pregnancy test or women who are lactating
- have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)
- had more than 1 episode of severe hypoglycemia within 6 months prior to study
- undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
- had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia
- are receiving systemic glucocorticoid therapy
- have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)
- show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia
- smoke more than 10 cigarettes (or equivalent other tobacco products) per day
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: LY2963016
A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.
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Single 0.3 U/kg dose administered subcutaneously
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Aktiv komparator: Lantus
A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
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Single 0.3 U/kg dose administered subcutaneously
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Tidsramme: Periods 1 and 2: Baseline up to 42 hours postdose
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Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion.
Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Maximum Glucose Infusion Rate (Rmax)
Tidsramme: Periods 1 and 2: Baseline up to 42 hours postdose
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Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
Data presented are the maximum infusion rates, adjusted by body weight.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Total Glucose Infused (Gtot)
Tidsramme: Periods 1 and 2: Baseline up to 42 hours postdose
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Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
Data presented are the total glucose infused, adjusted by body weight.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Time of Maximum Glucose Infusion Rate (tRmax)
Tidsramme: Periods 1 and 2: Baseline up to 42 hours postdose
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tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus
Tidsramme: Periods 1 and 2: Baseline up to 42 hours postdose
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Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus
Tidsramme: Periods 1 and 2: Baseline up to 42 hours postdose
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AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. maj 2012
Primær færdiggørelse (Faktiske)
1. juli 2012
Studieafslutning (Faktiske)
1. juli 2012
Datoer for studieregistrering
Først indsendt
15. maj 2012
Først indsendt, der opfyldte QC-kriterier
15. maj 2012
Først opslået (Skøn)
17. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. oktober 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. oktober 2014
Sidst verificeret
1. oktober 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13831
- I4L-MC-ABEE (Anden identifikator: Eli Lilly and Company)
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 .
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