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- Ensayo clínico NCT01600950
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
3 de octubre de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Neuss, Alemania, 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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 60 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximum Glucose Infusion Rate (Rmax)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2012
Finalización primaria (Actual)
1 de julio de 2012
Finalización del estudio (Actual)
1 de julio de 2012
Fechas de registro del estudio
Enviado por primera vez
15 de mayo de 2012
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2012
Publicado por primera vez (Estimar)
17 de mayo de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de octubre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
3 de octubre de 2014
Última verificación
1 de octubre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13831
- I4L-MC-ABEE (Otro identificador: Eli Lilly and Company)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Diabetes Mellitus, Tipo 1
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University of California, San FranciscoJuvenile Diabetes Research FoundationTerminadoDiabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMEstados Unidos, Australia
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University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes autoinmune | Diabetes Mellitus, Insulino-Dependiente | Diabetes de inicio juvenil | Diabetes Autoinmune | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | Diabetes Mellitus... y otras condicionesEstados Unidos
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Capillary Biomedical, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes Mellitus, Insulino-Dependiente, 1Australia
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Spiden AGDCB Research AGReclutamientoDiabetes mellitus tipo 1 | Diabetes mellitus tipo 1 con hipoglucemia | Diabetes mellitus tipo 1 con hiperglucemiaSuiza
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Instytut Diabetologii Sp. z o.o.National Center for Research and Development, Poland; Nalecz Institute of Biocybernetics...DesconocidoDiabetes mellitus tipo 1 con hiperglucemia | Diabetes mellitus tipo 1 con hipoglucemiaPolonia
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Capillary Biomedical, Inc.TerminadoDiabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMAustria
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National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)TerminadoDiabetes mellitus tipo 1 | DM1 | DT1 | Diabetes mellitus tipo 1 de nueva apariciónEstados Unidos, Australia
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Shanghai Changzheng HospitalReclutamientoDiabetes mellitus frágil tipo 1Porcelana
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SanofiTerminadoDiabetes Mellitus Tipo 1-Diabetes Mellitus Tipo 2Hungría, Federación Rusa, Alemania, Polonia, Japón, Estados Unidos, Finlandia
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Hoffmann-La RocheRoche DiagnosticsTerminadoDiabetes Mellitus Tipo 2, Diabetes Mellitus Tipo 1Alemania
Ensayos clínicos sobre LY2963016
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Eli Lilly and CompanyTerminado
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Eli Lilly and CompanyTerminadoUn estudio de insulina glargina (LY2963016) en participantes adultos con diabetes tipo 2 en la IndiaDiabetes mellitus tipo 2India
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Eli Lilly and CompanyRetiradoDiabetes tipo 2 | Diabetes tipo 2 tratada con insulinaEstados Unidos
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Eli Lilly and CompanyTerminado
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Eli Lilly and CompanyBoehringer IngelheimTerminadoDiabetes Mellitus, Tipo 2Estados Unidos, Puerto Rico, México, Corea, república de, Alemania, Polonia, Taiwán, España, Grecia, Francia, República Checa, Hungría
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Eli Lilly and CompanyTerminado
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Eli Lilly and CompanyBoehringer IngelheimTerminadoDiabetes Mellitus, Tipo 1Japón, Estados Unidos, Grecia, Bélgica, Polonia, Alemania, Hungría, México, Rumania
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Eli Lilly and CompanyTerminado
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Eli Lilly and CompanyTerminadoDiabetes mellitusSingapur
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Eli Lilly and CompanyTerminadoDiabetes mellitusSudáfrica