Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
20 de septiembre de 2017 actualizado por: Animas Corporation
16-week, open-label, multi-center pilot study.
Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of either: 1) ≥ 2 OAs (Cohort A), 2) basal insulin ± OAs (Cohort B), or 3) basal-bolus insulin ± OAs (Cohort C) will initiate basal-bolus therapy with an insulin pump using a rapid-acting insulin analog.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
58
Fase
- No aplica
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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California
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La Jolla, California, Estados Unidos, 92093
- The Regents of the University of California on behalf of its San Diego campus
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San Diego, California, Estados Unidos, 92026
- AMCR Institute, Inc.
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Georgia
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Atlanta, Georgia, Estados Unidos, 30309
- Atlanta Diabetes Associates, Inc.
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
- Rocky Mountain Diabetes and Osteoporosis Center, PA
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Kentucky Diabetes Endocrinology Center
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- DGD Research, Inc.
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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 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Is 18 to 75 years of age, inclusive;
- Has a clinical diagnosis of type 2 diabetes mellitus;
- Is anti-glutamic acid decarboxylase (GAD) antibody negative;
- Has an A1C ≥ 7.0% and ≤ 10.5%;
- Has a body mass index (BMI) ≥ 25 kg/m2 and ≤ 40 kg/m2;
- Is treated with either ≥ 2 oral antidiabetic agents (OA) or basal insulin ± OA(s) or basal-bolus insulin ± OA(s) for at least 3 months (Subjects may also be treated with exenatide [Byetta] or pramlintide [Symlin].
- If on concomitant metformin, has serum creatinine < 1.5 mg/dL (male) or <1.4 mg/dL (female);
- If female, has a negative urine pregnancy test
Exclusion Criteria:
- Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months;
- Has clinical cardiovascular disease (CVD) as evidenced by prior myocardial infarction, stroke, arterial revascularization and/or angina with ischemic changes on ECG at rest, changes on graded exercise test, or positive cardiac imaging test results;
- Has abnormalities on the screening (Visit 1) 12-lead ECG that are deemed by the investigator to be clinically significant;
- Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route or potent inhaled,intrapulmonary, intranasal, or topical steroids that are known to have a high rate of systemic absorption;
- Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be non-compliant;
- Has any significant medical condition, laboratory findings, or medical history that in the investigator's opinion may affect successful completion of the study and/or personal well-being;
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: Viabilidad del dispositivo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: A
Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of ≥ 2 OAs
|
Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
|
|
Otro: B
Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of basal insulin ± OAs
|
Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
|
|
Otro: C
Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen basal-bolus insulin ± OAs
|
Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Insulin doses at Week 16
Periodo de tiempo: Week 16
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To evaluate insulin doses after 16 weeks of insulin pump therapy aimed at achieving normal or near-normal glycemic control in subjects with type 2 diabetes.This included the total daily insulin dose, basal and bolus insulin doses.
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Week 16
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Ratio of Basal-to-Bolus Insulin Dose at Week 16
Periodo de tiempo: 16 weeks
|
Evaluate insulin dosing patterns after 16 weeks of insulin pump therapy aimed at safely achieving normal or near-normal glycemic control in patients with type 2 diabetes
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16 weeks
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Number of daily basal rates at Week 16
Periodo de tiempo: Week 16
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To evaluate insulin dosing patterns, i.e., number of daily basal rates, after 16 weeks of insulin pump therapy aimed at achieving normal or near-normal glycemic control in subjects with type 2 diabetes.
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Week 16
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
A1C (Hemoglobin A1c)
Periodo de tiempo: Week 16
|
To evaluate the effect of 16 weeks of insulin pump therapy in subjects with type 2 diabetes on glycemic outcome
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Week 16
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7 point profile
Periodo de tiempo: Week 16
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Self-monitored 7-point profiles were compared at baseline and Week 16 for each cohort and all cohorts combined.
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Week 16
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CGM Glucose Ranges - Percent of Measurements
Periodo de tiempo: End of study
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The percent of glucose values within the target range of 70-180 mg/dL, as measured by CGM
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End of study
|
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Body Weight
Periodo de tiempo: Week 16
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Weight change was evaluated at Week 16 for each cohort and all cohorts combined.
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Week 16
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Hypoglycemia
Periodo de tiempo: Week 16
|
The incidence (percent of patients with at least one episode of hypoglycemia) of minor hypoglycemia was evaluated respectively.
Minor hypoglycemia was defined as symptoms consistent with hypoglycemia that either resolved spontaneously or upon self-treatment with oral carbohydrate.
Severe hypoglycemia referred to symptoms consistent with hypoglycemia during which the patient required the assistance of another individual and was associated with a documented glucose concentration less than 56 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon.
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Week 16
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Change from baseline to week 16 in Patient Reported Outcomes (PROs)
Periodo de tiempo: Week 16
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PROs were assessed at Baseline, Wk 8 (except for EQ-5D) and Wk 16, including EuroQol-5 Dimensions (EQ-5D) (Generic health-related QoL), Diabetes Symptom Checklist-Revised (DSC-R) (Diabetes-specific QoL), and Insulin Delivery System Rating Questionnaire (IDSRQ) (Treatment Satisfaction with insulin delivery system)
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Week 16
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sunder Mudaliar, MD, University of California, San Diego
- Investigador principal: Timothy Bailey, MD, AMCR Institute, Inc.
- Investigador principal: Bruce Bode, MD, Atlanta Diabetes Associates, Inc.
- Investigador principal: Mark Kipnes, MD, DGD Research, Inc.
- Investigador principal: John Liljenquist, MD, Rocky Mountain Diabetes and Osteoporosis Center, PA
- Investigador principal: Lyle Myers, M.D, Kentucky Diabetes Endocrinology Center
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
- Peyrot M, Rubin RR, Chen X, Frias JP. Associations between improved glucose control and patient-reported outcomes after initiation of insulin pump therapy in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2011 Apr;13(4):471-6. doi: 10.1089/dia.2010.0167. Epub 2011 Feb 28.
- Rubin RR, Peyrot M, Chen X, Frias JP. Patient-reported outcomes from a 16-week open-label, multicenter study of insulin pump therapy in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2010 Nov;12(11):901-6. doi: 10.1089/dia.2010.0075. Epub 2010 Sep 30.
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 (Actual)
1 de febrero de 2008
Finalización primaria (Actual)
1 de diciembre de 2008
Finalización del estudio (Actual)
1 de enero de 2009
Fechas de registro del estudio
Enviado por primera vez
13 de marzo de 2008
Primero enviado que cumplió con los criterios de control de calidad
16 de junio de 2009
Publicado por primera vez (Estimar)
17 de junio de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de septiembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
20 de septiembre de 2017
Última verificación
1 de septiembre de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ANM002
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. .