Efficacy and safety of insulin glargine 300 U/mL (Gla-300) during hospitalization and therapy intensification at discharge in patients with insufficiently controlled type 2 diabetes: results of the phase IV COBALTA trial.
Por:
Perez A, Carrasco-Sánchez FJ, González C, Segui J, Trescolí C, Ena J, Borrell M and Gomez Huelgas R
Publicada:
1 sep 2020
Categoría:
Endocrinology, diabetes and metabolism
Resumen:
INTRODUCTION: This study assessed the efficacy and safety of insulin glargine 300 U/mL (Gla-300) during hospitalization and therapy intensification at discharge in insufficiently controlled people with type 2 diabetes. RESEARCH DESIGN AND METHODS: COBALTA (for its acronym in Spanish, COntrol Basal durante la hospitalizacion y al ALTA) was a multicenter, open-label, single-arm, phase IV trial including 112 evaluable inpatients with type 2 diabetes insufficiently controlled (glycosylated hemoglobin (HbA1c) 8%-10%) with basal insulin and/or non-insulin antidiabetic drugs. Patients were treated with a basal-bolus-correction insulin regimen with Gla-300 during the hospitalization and with Gla-300 and/or non-insulin antidiabetics for 6 months after discharge. The primary endpoint was the HbA1c change from baseline to month 6 postdischarge. RESULTS: HbA1c levels decreased from 8.8%±0.6% at baseline to 7.2%±1.1% at month 6 postdischarge (p<0.001, mean change 1.6%±1.1%). All 7-point blood glucose levels decreased from baseline to 24 hours predischarge (p=0.001, mean changes from 25.1±66.6 to 63.0±85.4 mg/dL). Fasting plasma glucose also decreased from baseline to 24 hours predischarge (p<0.001), month 3 (p<0.001) and month 6 (p<0.001) postdischarge (mean changes 51.5±90.9, 68.2±96.0 and 77.6±86.4 mg/dL, respectively). Satisfaction was high and hyperglycemia/hypoglycemia perception was low according to the Diabetes Treatment Satisfaction Questionnaire at month 6 postdischarge. The incidence of confirmed (glucose<70 mg/dL)/severe hypoglycemia was 25.0% during hospitalization and 59.1% 6 months after discharge. No safety concerns were reported. CONCLUSIONS: Inpatient and intensification therapy at discharge with Gla-300 improved significantly glycemic control of patients with type 2 diabetes insufficiently controlled with other basal insulin and/or non-insulin antidiabetic medication, with high treatment satisfaction. Gla-300 could therefore be a treatment choice for hospital and postdischarge diabetes management.
Filiaciones:
Perez A:
Department of Endocrinology and Nutrition, Hospital de la Santa Creu i Sant Pau, CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Universitat Autònoma de Barcelona, Barcelona, Spain
Carrasco-Sánchez FJ:
Department of Internal Medicine, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain
González C:
Department of Internal Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain
Segui J:
Department of Internal Medicine, Hospital Universitario San Joan d'Alacant, Sant Joan d'Alacant, Spain
:
Department of Internal Medicine, Hospital Universitario de La Ribera, Alzira, Spain
:
Department of Internal Medicine, Hospital Marina Baixa, Villajoyosa, Spain
Borrell M:
Medical Department, Sanofi, Barcelona, Spain
Gomez Huelgas R:
Department of Internal Medicine, Hospital Regional Universitario de Málaga, Málaga, Instituto de Investigación Biomédica de Málaga, Universidad de Málaga
CIBER Fisiopatología de la Obesidad y la Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain
Green Published, gold
|