Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
21 de octubre de 2016 actualizado por: AstraZeneca
A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications
This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
261
Fase
- Fase 3
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
-
-
Arizona
-
Peoria, Arizona, Estados Unidos
- Research Site
-
Phoenix, Arizona, Estados Unidos
- Research Site
-
-
California
-
Buena Park, California, Estados Unidos
- Research Site
-
Concord, California, Estados Unidos
- Research Site
-
Fresno, California, Estados Unidos
- Research Site
-
Greenbrae, California, Estados Unidos
- Research Site
-
La Mesa, California, Estados Unidos
- Research Site
-
Lancaster, California, Estados Unidos
- Research Site
-
Northridge, California, Estados Unidos
- Research Site
-
Palm Springs, California, Estados Unidos
- Research Site
-
Salinas, California, Estados Unidos
- Research Site
-
-
Florida
-
Hollywood, Florida, Estados Unidos
- Research Site
-
Jacksonville, Florida, Estados Unidos
- Research Site
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos
- Research Site
-
-
Hawaii
-
Honolulu, Hawaii, Estados Unidos
- Research Site
-
-
Idaho
-
Idaho Falls, Idaho, Estados Unidos
- Research Site
-
-
Iowa
-
Des Moines, Iowa, Estados Unidos
- Research Site
-
-
Kansas
-
Wichita, Kansas, Estados Unidos
- Research Site
-
-
Louisiana
-
Baton Rouge, Louisiana, Estados Unidos
- Research Site
-
Lafayette, Louisiana, Estados Unidos
- Research Site
-
Matairie, Louisiana, Estados Unidos
- Research Site
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos
- Research Site
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos
- Research Site
-
-
Missouri
-
Chesterfield, Missouri, Estados Unidos
- Research Site
-
St Louis, Missouri, Estados Unidos
- Research Site
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos
- Research Site
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos
- Research Site
-
-
New Jersey
-
Berkeley Heights, New Jersey, Estados Unidos
- Research Site
-
Teaneck, New Jersey, Estados Unidos
- Research Site
-
-
New Mexico
-
Alburquerque, New Mexico, Estados Unidos
- Research Site
-
-
New York
-
New York, New York, Estados Unidos
- Research Site
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos
- Research Site
-
-
Oregon
-
Bend, Oregon, Estados Unidos
- Research Site
-
-
Texas
-
Dallas, Texas, Estados Unidos
- Research Site
-
El Paso, Texas, Estados Unidos
- Research Site
-
Georgetown, Texas, Estados Unidos
- Research Site
-
San Antonio, Texas, Estados Unidos
- Research Site
-
-
Virginia
-
Richmond, Virginia, Estados Unidos
- Research Site
-
-
Washington
-
Vancouver, Washington, Estados Unidos
- Research Site
-
-
Wisconsin
-
Kenosha, Wisconsin, Estados Unidos
- Research Site
-
-
-
-
-
Athens, Grecia
- Research Site
-
Thessaloniki, Grecia
- Research Site
-
-
-
-
-
Holon, Israel
- Research Site
-
Kfar Sava, Israel
- Research Site
-
Tel Hashomer, Israel
- Research Site
-
-
-
-
-
Coatzacoalcos, México
- Research Site
-
Mexico, México
- Research Site
-
Monterrey, México
- Research Site
-
-
-
-
-
Carolina, Puerto Rico
- Research Site
-
Hato Rey, Puerto Rico
- Research Site
-
Ponce, Puerto Rico
- Research Site
-
San Juan, Puerto Rico
- Research Site
-
-
-
-
-
Birmingham, Reino Unido
- Research Site
-
Guildford, Reino Unido
- Research Site
-
Leicester, Reino Unido
- Research Site
-
Livingston, Reino Unido
- Research Site
-
Middlesbrough, Reino Unido
- Research Site
-
Swansea, Reino Unido
- Research Site
-
Torquay, Reino Unido
- Research Site
-
-
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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Have type 2 diabetes.
- Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.
Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:
- metformin (stable dose for 6 weeks)
- pioglitazone (stable dose for 6 weeks)
a combination of metformin and pioglitazone (stable dose for 6 weeks)
- Have HbA1C between 7.1% and 10.5%, inclusive.
- Have a body mass index (BMI) ≤45 kg/m2.
- Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
Exclusion Criteria:
- Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
- Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
- Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
- Women who are breastfeeding.
- Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
- Have had a kidney transplant or are currently on kidney dialysis.
- Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
- Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
- Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
- Are currently on a weight-loss program or have been on one within 3 months of entering the study.
- Have had a blood transfusion or severe blood loss within 3 months of entering the study.
- Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
- Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
- Have a history of pancreatitis.
- Have received treatment with an experimental drug within 30 days of entering the study.
- If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
- If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
- If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.
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 paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 2
|
inyección subcutánea, dos veces al día, 10 mcg
|
|
Comparador de placebos: 1
|
inyección subcutánea, dos veces al día
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c)
Periodo de tiempo: baseline and 30 weeks
|
Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline).
Unit of measure is percent of hemoglobin that is glycosylated.
|
baseline and 30 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Patients Achieving HbA1c <=7%
Periodo de tiempo: baseline and 30 weeks
|
Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).
|
baseline and 30 weeks
|
|
Percentage of Patients Achieving HbA1c <=6.5%
Periodo de tiempo: baseline and 30 weeks
|
Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).
|
baseline and 30 weeks
|
|
Change in Fasting Serum Glucose
Periodo de tiempo: baseline and 30 weeks
|
Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
|
baseline and 30 weeks
|
|
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Periodo de tiempo: baseline and 30 weeks
|
Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)
|
baseline and 30 weeks
|
|
Change in Total Cholesterol
Periodo de tiempo: baseline and 30 weeks
|
Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
|
baseline and 30 weeks
|
|
Change in Low Density Lipoprotein (LDL) Cholesterol
Periodo de tiempo: baseline and 30 weeks
|
Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
|
baseline and 30 weeks
|
|
Change in High Density Lipoprotein (HDL) Cholesterol
Periodo de tiempo: baseline and 30 weeks
|
Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
|
baseline and 30 weeks
|
|
Change in Triglycerides
Periodo de tiempo: baseline and 30 weeks
|
Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
|
baseline and 30 weeks
|
|
Change in Body Weight
Periodo de tiempo: baseline and 30 weeks
|
Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
|
baseline and 30 weeks
|
|
Change in Waist Circumference
Periodo de tiempo: baseline and 30 weeks
|
Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
|
baseline and 30 weeks
|
|
Change in Daily Insulin Dose
Periodo de tiempo: baseline and 30 weeks
|
Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
|
baseline and 30 weeks
|
|
Change in Daily Insulin Dose (on a Per Body Weight Basis)
Periodo de tiempo: baseline and 30 weeks
|
Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)
|
baseline and 30 weeks
|
|
Change in Systolic Blood Pressure (SBP)
Periodo de tiempo: baseline and 30 weeks
|
Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
|
baseline and 30 weeks
|
|
Change in Diastolic Blood Pressure (DBP)
Periodo de tiempo: baseline and 30 weeks
|
Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
|
baseline and 30 weeks
|
|
Minor Hypoglycemia Rate Per Year
Periodo de tiempo: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
|
Number of minor hypoglycemia events experienced per subject per year.
Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
|
baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
|
|
Percentage of Subjects Experiencing Minor Hypoglycemia
Periodo de tiempo: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
|
Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study.
Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
|
baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
- Buse JB, Han J, Miller S, MacConell L, Pencek R, Wintle M. Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18.
- Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5.
- Rosenstock J, Shenouda SK, Bergenstal RM, Buse JB, Glass LC, Heilmann CR, Kwan AY, MacConell LA, Hoogwerf BJ. Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes. Diabetes Care. 2012 May;35(5):955-8. doi: 10.2337/dc11-1434. Epub 2012 Mar 19.
- Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011 Jan 18;154(2):103-12. doi: 10.7326/0003-4819-154-2-201101180-00300. Epub 2010 Dec 6.
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 octubre de 2008
Finalización primaria (Actual)
1 de enero de 2010
Finalización del estudio (Actual)
1 de enero de 2010
Fechas de registro del estudio
Enviado por primera vez
1 de octubre de 2008
Primero enviado que cumplió con los criterios de control de calidad
1 de octubre de 2008
Publicado por primera vez (Estimar)
3 de octubre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de octubre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2016
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Diabetes Mellitus, Tipo 2
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes contra la obesidad
- Incretinas
- Exenatida
Otros números de identificación del estudio
- H8O-US-GWCO
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. .