Observational Study on Safety of Self-titration of Once Daily Levemir® (SOLVE™)
2 de febrero de 2017 actualizado por: Novo Nordisk A/S
Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents
This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time. The study will also look at the blood glucose control, frequency of dose adjustment, clinic visits, and time spent training patients to self-titrate.
The objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid late stage diabetic complications. Self-titration (where patients adjust insulin dosage themselves) offers the potential for better blood glucose control than titration only at clinic visits. In recent years treatment of type 2 diabetes in the United Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2 diabetes, in general, have not been trained in self-titration to the same degree as patients with type 1 diabetes. Less experience in self-titration could impact the level of blood glucose control and outcome for these patients.
Data from this study will be pooled with data from NN304-3714 (NCT00825643) and will be reported in the final study report for NN304-3714.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
882
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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Crawley, Reino Unido, RH11 9RT
- Novo Nordisk Investigational Site
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients from a primary care setting who have been deemed appropriate to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing health care professional.
Descripción
Inclusion Criteria:
- After the participating physician/nurse's decision has been made to initiate once daily Levemir® therapy (within the license of the product), any patient with type 2 diabetes of 18 years or older who is currently treated with diet, exercise and one or more OADs can be offered to participate
Exclusion Criteria:
- Patients unable to give written informed consent
- Current treatment with insulin
- Patient deemed unable or unwilling to self-titrate
- Known or suspected allergy to study product or related products
- Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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A
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Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of serious adverse drug reactions including major hypoglycaemic events
Periodo de tiempo: during treatment
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during treatment
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of serious adverse events and all adverse events
Periodo de tiempo: during treatment
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during treatment
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Incidence of hypoglycaemic events
Periodo de tiempo: in the 4 weeks preceding the baseline, 12 and 20 week visits
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in the 4 weeks preceding the baseline, 12 and 20 week visits
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HbA1c
Periodo de tiempo: at the interim study visit at 12 weeks and the end of the study visit at 20 weeks
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at the interim study visit at 12 weeks and the end of the study visit at 20 weeks
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Variability and mean of the patient's self-monitored plasma glucose measurements
Periodo de tiempo: at approximately 12 and 20 weeks
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at approximately 12 and 20 weeks
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Proportion of patients who achieved equal or greater than 1% HbA1c reduction after initiation of insulin detemir without experiencing hypoglycaemic episodes
Periodo de tiempo: at approximately 12 and 20 weeks
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at approximately 12 and 20 weeks
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Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo
Periodo de tiempo: defined by the average of the last three FBGs
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defined by the average of the last three FBGs
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Body weight
Periodo de tiempo: at approximately 12 and 20 weeks
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at approximately 12 and 20 weeks
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Frequency of insulin adjustment
Periodo de tiempo: at approximately 12 and 20 weeks
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at approximately 12 and 20 weeks
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Total number of visits/contacts to the clinic, related to titration
Periodo de tiempo: at approximately 12 and 20 weeks
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at approximately 12 and 20 weeks
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HCP time used on titration training
Periodo de tiempo: at baseline and approximately 12 and 20 weeks
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at baseline and approximately 12 and 20 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
- Khunti K, Damci T, Meneghini L, Pan CY, Yale JF; SOLVE Study Group. Study of Once Daily Levemir (SOLVE): insights into the timing of insulin initiation in people with poorly controlled type 2 diabetes in routine clinical practice. Diabetes Obes Metab. 2012 Jul;14(7):654-61. doi: 10.1111/j.1463-1326.2012.01602.x. Epub 2012 Apr 22.
- Ross S, Dzida G, Ji Q, Kaiser M, Ligthelm R, Meneghini L, Nazeri A, Orozco-Beltran D, Pan C, Svendsen AL; SOLVE Study Group. Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice. J Diabetes. 2014 May;6(3):243-50. doi: 10.1111/1753-0407.12091. Epub 2013 Oct 29.
- Vora J, Caputo S, Damci T, Orozco-Beltran D, Pan C, Svendsen AL, Solje KS, Khunti K; SOLVE study group. Effect of once-daily insulin detemir on oral antidiabetic drug (OAD) use in patients with type 2 diabetes. J Clin Pharm Ther. 2014 Apr;39(2):136-43. doi: 10.1111/jcpt.12116. Epub 2013 Dec 13.
- Khunti K, Vora J, Davies M. Results from the UK cohort of SOLVE: providing insights into the timing of insulin initiation in people with poorly controlled type 2 diabetes in routine clinical practice. Prim Care Diabetes. 2014 Apr;8(1):57-63. doi: 10.1016/j.pcd.2013.11.010. Epub 2013 Dec 27.
- Khunti K, Damci T, Husemoen LL, Babu V, Liebl A. Exploring the characteristics of suboptimally controlled patients after 24weeks of basal insulin treatment: An individualized approach to intensification. Diabetes Res Clin Pract. 2017 Jan;123:209-217. doi: 10.1016/j.diabres.2016.11.028. Epub 2016 Dec 9.
- Orozco-Beltran D, Pan C, Svendsen AL, Faerch L, Caputo S; SOLVE Study Group. Basal insulin initiation in primary vs. specialist care: similar glycaemic control in two different patient populations. Int J Clin Pract. 2016 Mar;70(3):236-43. doi: 10.1111/ijcp.12776. Epub 2016 Feb 24.
- Damci T, Emral R, Svendsen AL, Balkir T, Vora J; SOLVE study group. Lower risk of hypoglycaemia and greater odds for weight loss with initiation of insulin detemir compared with insulin glargine in Turkish patients with type 2 diabetes mellitus: local results of a multinational observational study. BMC Endocr Disord. 2014 Jul 21;14:61. doi: 10.1186/1472-6823-14-61.
- Yale JF, Damci T, Kaiser M, Karnieli E, Khunti K, Liebl A, Baeres FM, Svendsen AL, Ross SA; SOLVE Study Group. Initiation of once daily insulin detemir is not associated with weight gain in patients with type 2 diabetes mellitus: results from an observational study. Diabetol Metab Syndr. 2013 Oct 2;5(1):56. doi: 10.1186/1758-5996-5-56.
- Liebl A, Andersen H, Svendsen AL, Vora J, Yale JF; SOLVE Study Group. Resource utilisation and quality of life following initiation of insulin detemir in patients with type 2 diabetes mellitus. Int J Clin Pract. 2013 Aug;67(8):740-9. doi: 10.1111/ijcp.12133.
- Karnieli E, Baeres FM, Dzida G, Ji Q, Ligthelm R, Ross S, Svendsen AL, Yale JF; SOLVE Study Group. Observational study of once-daily insulin detemir in people with type 2 diabetes aged 75 years or older: a sub-analysis of data from the Study of Once daily LeVEmir (SOLVE). Drugs Aging. 2013 Mar;30(3):167-75. doi: 10.1007/s40266-013-0054-3.
- Liebl A, Wilhelm B, Kaiser M. [Once daily insulin detemir in patients with type 2 diabetes: results of German centers in a 6-month international observational study (SOLVE)]. MMW Fortschr Med. 2012 Dec 17;154 Suppl 4:102-9. German.
Enlaces Útiles
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 septiembre de 2008
Finalización primaria (Actual)
1 de marzo de 2011
Finalización del estudio (Actual)
1 de marzo de 2011
Fechas de registro del estudio
Enviado por primera vez
19 de agosto de 2008
Primero enviado que cumplió con los criterios de control de calidad
22 de agosto de 2008
Publicado por primera vez (Estimar)
25 de agosto de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
3 de febrero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
2 de febrero de 2017
Última verificación
1 de febrero de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NN304-3573
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. .