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
Pérez Pérez, Antonio (Institut d'Investigació Biomèdica Sant Pau)
Carrasco-Sánchez, Francisco Javier (Hospital Juan Ramón Jiménez (Huelva))
González, Carlos (Hospital Universitario 12 de Octubre (Madrid))
Seguí-Ripoll, José Miguel (Hospital Universitario San Juan de Alicante)
Trescolí, Carlos (Hospital Universitari de la Ribera (València))
Ena, Javier (Hospital Marina Baixa (La Vila Joiosa, Alacant))
Borrell, Mireia (Sanofi)
Gomez Huelgas, Ricardo (Instituto de Investigación Biomédica de Málaga)
Universitat Autònoma de Barcelona

Data:	2020
Resum:	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. 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. 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. 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Blood glucose ; Hypoglycemia ; Insulin glargine ; Diabetes mellitus ; Type 2
Publicat a:	BMJ open diabetes research and care, Vol. 8 (september 2020) , ISSN 2052-4897

DOI: 10.1136/bmjdrc-2020-001518
PMID: 32928792

10 p, 577.9 KB

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