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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

12 de enero de 2011 actualizado por: Eli Lilly and Company

A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

Descripción general del estudio

Estado

Terminado

Condiciones

Diabetes Mellitus, Tipo 2

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

339

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

Estados Unidos
- Arizona
  - Phoenix, Arizona, Estados Unidos, 85028
    - 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.
- California
  - Concord, California, Estados Unidos, 94520
    - 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.
  - Escondido, California, Estados Unidos, 92026
    - 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.
  - Fresno, California, Estados Unidos, 93720
    - 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.
  - Modesto, California, Estados Unidos, 95355
    - 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.
  - Orange, California, Estados Unidos, 92869
    - 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.
- Florida
  - Inverness, Florida, Estados Unidos, 34452
    - 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.
  - Jacksonville, Florida, Estados Unidos, 32204
    - 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.
  - Lake Worth, Florida, Estados Unidos, 33461
    - 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.
  - Miami, Florida, Estados Unidos, 33183
    - 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.
  - Orlando, Florida, Estados Unidos, 32804
    - 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.
  - Palm Harbor, Florida, Estados Unidos, 34684
    - 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.
  - Pembroke Pines, Florida, Estados Unidos, 33029
    - 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.
  - Plantation, Florida, Estados Unidos, 33324
    - 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.
  - West Palm Beach, Florida, Estados Unidos, 33401
    - 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.
- Hawaii
  - Honolulu, Hawaii, Estados Unidos, 96813
    - 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.
- Idaho
  - Idaho Falls, Idaho, Estados Unidos, 83404
    - 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.
- Indiana
  - Avon, Indiana, Estados Unidos, 46123
    - 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.
  - Bloomington, Indiana, Estados Unidos, 47403
    - 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.
  - South Bend, Indiana, Estados Unidos, 46617
    - 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.
- Iowa
  - Des Moines, Iowa, Estados Unidos, 50314
    - 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.
- Kentucky
  - Lexington, Kentucky, Estados Unidos, 40503
    - 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.
- Louisiana
  - Baton Rouge, Louisiana, Estados Unidos, 70808
    - 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.
  - Lafayette, Louisiana, Estados Unidos, 70503
    - 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.
  - Metairie, Louisiana, Estados Unidos, 70006
    - 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.
- Maine
  - Biddeford, Maine, Estados Unidos, 04005
    - 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.
- Missouri
  - Chesterfield, Missouri, Estados Unidos, 63017
    - 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.
  - Jefferson City, Missouri, Estados Unidos, 65109
    - 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.
  - St Louis, Missouri, Estados Unidos, 63104
    - 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.
- Nebraska
  - Omaha, Nebraska, Estados Unidos, 68131
    - 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.
- Nevada
  - Las Vegas, Nevada, Estados Unidos, 89148
    - 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.
- New Hampshire
  - Nashua, New Hampshire, Estados Unidos, 03063
    - 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.
- New York
  - Rochester, New York, Estados Unidos, 14607
    - 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.
  - Syracuse, New York, Estados Unidos, 13210
    - 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.
- North Carolina
  - Morehead City, North Carolina, Estados Unidos, 28557
    - 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.
- Ohio
  - London, Ohio, Estados Unidos, 43140
    - 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.
  - Mason, Ohio, Estados Unidos, 45040
    - 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.
  - Toledo, Ohio, Estados Unidos, 43606
    - 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.
- South Carolina
  - Greer, South Carolina, Estados Unidos, 29651
    - 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.
  - Myrtle Beach, South Carolina, Estados Unidos, 29572
    - 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.
- Tennessee
  - Kingsport, Tennessee, Estados Unidos, 37660
    - 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.
  - Memphis, Tennessee, Estados Unidos, 38119
    - 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.
- Texas
  - Austin, Texas, Estados Unidos, 78731
    - 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.
  - Dallas, Texas, Estados Unidos, 75231
    - 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.
  - San Antonio, Texas, Estados Unidos, 78229
    - 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.
- Vermont
  - South Burlington, Vermont, Estados Unidos, 05403
    - 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.
- Virginia
  - Virginia Beach, Virginia, Estados Unidos, 23462
    - 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.
- Washington
  - Spokane, Washington, Estados Unidos, 99202
    - 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.
  - Vancouver, Washington, Estados Unidos, 98664
    - 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.
Puerto Rico
- - Ponce, Puerto Rico, 00731
    - 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.
  - Toa Baja, Puerto Rico, 00949
    - 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.
  - Yabucoa, Puerto Rico, 00767
    - 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.

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 74 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Must have type 2 diabetes
Must be at least 18 years of age and less than 75 years of age
Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion Criteria:

Must not have used insulin on a regular basis during the past 2 years
Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
Must not have had more than one episode of severe hypoglycemia in the past 6 months
Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
Must not be pregnant or intend to get pregnant during the course of the study

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: Ninguno (etiqueta abierta)

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Comparador activo: ILPS Insulin Lispro Protamine Suspension (ILPS)	Droga: Insulin Lispro Protamine Suspension Administered subcutaneously once a day at bedtime Otros nombres: LY275585[P]
Comparador activo: Glargine Insulin Glargine	Droga: Insulin Glargine Administered subcutaneously once a day at bedtime Otros nombres: Lantus

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) Periodo de tiempo: Baseline, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.	Baseline, Endpoint (LOCF) up to 24 weeks

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) Periodo de tiempo: 24 weeks, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.	24 weeks, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) Periodo de tiempo: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.	Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5% Periodo de tiempo: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks		Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF) Periodo de tiempo: Baseline, Endpoint (LOCF) up to 24 weeks	SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.	Baseline, Endpoint (LOCF) up to 24 weeks
Glycemic Variability at Baseline and Endpoint (LOCF) Periodo de tiempo: Baseline, Endpoint (LOCF) up to 24 weeks	Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.	Baseline, Endpoint (LOCF) up to 24 weeks
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe) Periodo de tiempo: Baseline to Endpoint (LOCF) up to 24 weeks	Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.	Baseline to Endpoint (LOCF) up to 24 weeks
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year) Periodo de tiempo: Baseline to Endpoint (LOCF) up to 24 weeks	Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.	Baseline to Endpoint (LOCF) up to 24 weeks
Actual Body Weight at Baseline and Endpoint (LOCF) Periodo de tiempo: Baseline, Endpoint (LOCF) up to 24 weeks		Baseline, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Body Weight at Endpoint (LOCF) Periodo de tiempo: Baseline, Endpoint (LOCF) up to 24 weeks		Baseline, Endpoint (LOCF) up to 24 weeks
Total Daily Insulin Dose at Endpoint (LOCF) Periodo de tiempo: Endpoint (LOCF) up to 24 weeks		Endpoint (LOCF) up to 24 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

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 noviembre de 2007

Finalización primaria (Actual)

1 de diciembre de 2009

Finalización del estudio (Actual)

1 de diciembre de 2009

Fechas de registro del estudio

Enviado por primera vez

15 de noviembre de 2007

Primero enviado que cumplió con los criterios de control de calidad

15 de noviembre de 2007

Publicado por primera vez (Estimar)

19 de noviembre de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de enero de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

12 de enero de 2011

Última verificación

1 de enero de 2011

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

11647
F3Z-US-IOPB (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. .

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Aydin Adnan Menderes University; Izmir University of Economics; Buca Seyfi Demirsoy... y otros colaboradores

Aún no reclutando

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Endogenex, Inc.

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Acceso continuo al sistema Endogenex para los participantes en el estudio fundamental recet

Diabetes Mellitus, Tipo 2 | Diabetes | Diabetes mellitus tipo 2 | Diabetes tipo 2 | Diabetes tipo 2
Endogenex, Inc.

Aún no reclutando

Registro de vigilancia posterior al mercado para el sistema Endogenex (Registro de pulso de Endogenex)

Diabetes Mellitus, Tipo 2 | Diabetes | Diabetes tipo 2 | Diabetes mellitus tipo 2 (DM2) | Diabetes tipo 2
Steno Diabetes Center Copenhagen

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Estados Unidos
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Aún no reclutando

Intervención conductual grupal centrada en la emoción para la angustia de diabetes/A1C en la diabetes T2.

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Global Institute of Stem Cell Therapy and Research

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Un ensayo clínico de fase IIa doble ciego, aleatorizado, controlado con placebo para evaluar la seguridad y la eficacia de DT2-SCT en sujetos con diabetes mellitus tipo 2

Diabetes mellitus tipo 2 (DM2)

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

Descripción general del estudio

Estado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Inscripción (Actual)

Fase

Contactos y Ubicaciones

Ubicaciones de estudio

Criterios de participación

Criterio de elegibilidad

Edades elegibles para estudiar

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Géneros elegibles para el estudio

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Plan de estudios

¿Cómo está diseñado el estudio?

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Armas e Intervenciones

Grupo de participantes/brazo

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Medidas de resultado primarias

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Colaboradores e Investigadores

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Fechas de registro del estudio

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Finalización del estudio (Actual)

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

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CROs by country

CROs in Paraguay

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