NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes.
NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is important for controlling insulin levels. Insulin, another hormone, is also important for controlling blood glucose levels, which are higher than normal in people who have type 2 diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations. These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes. Also, various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn.
One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study, and the effects of this dose will be compared to a placebo (inactive substance that looks like the active drug). This is a crossover study, which means that subjects will be treated both with NNC 90-1170 and with placebo. The order in which subjects will receive the treatments will be determined by chance (randomly).
The study will be conducted as a so-called "double-blind" study, meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over.
The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in the United States.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
Subjects with Type 2 Diabetes
- Signed and dated informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject.
- Subjects diagnosed with type 2 diabetes according to the American Diabetes Association (ADA) criteria (6): fasting plasma glucose ?126 mg/dL (7.0 mmol/L) or 2-hour plasma glucose ? 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT).
- Subjects with type 2 diabetes either newly diagnosed with at least 2 months of diet or on oral anti-diabetic monotherapy for at least 3 months.
- Age 30-75 years inclusive. Body Mass Index 24 to 35 kg/m2 inclusive.
Healthy Volunteers
- The subject must give signed and dated informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject.
- Age 30-75 years inclusive.
- Body Mass Index 24 to 35 kg/m2 inclusive. Must meet the ADA criteria for normal glucose tolerance (6): fasting plasma glucose below 110 mg/dL (6.1 mmol/L) and 2-hour plasma glucose < 140 mg/mL (7.8 mmol/L) during an OGTT.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCRR-M01RR00042-1749
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 NNC 90-1170
-
Novo Nordisk A/STerminadoDiabetes Mellitus, Tipo 2 | DiabetesEstados Unidos
-
Novo Nordisk A/STerminado
-
Novo Nordisk A/STerminadoDiabetes Mellitus, Tipo 2 | DiabetesDinamarca
-
Novo Nordisk A/STerminadoDiabetes Mellitus, Tipo 2 | DiabetesDinamarca
-
Novo Nordisk A/STerminadoSaludable | Diabetes Mellitus, Tipo 2 | DiabetesReino Unido
-
Novo Nordisk A/STerminadoDiabetes Mellitus, Tipo 2 | DiabetesDinamarca
-
Novo Nordisk A/STerminadoDiabetes Mellitus, Tipo 2 | DiabetesEstados Unidos
-
Novo Nordisk A/STerminadoDiabetes Mellitus, Tipo 2 | DiabetesJapón
-
Novo Nordisk A/STerminadoDiabetes Mellitus, Tipo 2 | DiabetesAlemania
-
Novo Nordisk A/STerminado