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 ![Identificador ORCID](/img/uab/orcid.ico)
(Institut d'Investigació Biomèdica Sant Pau)
Carrasco-Sánchez, Francisco Javier ![Identificador ORCID](/img/uab/orcid.ico)
(Hospital Juan Ramón Jiménez (Huelva))
González, Carlos (Hospital Universitario 12 de Octubre (Madrid))
Seguí-Ripoll, José Miguel ![Identificador ORCID](/img/uab/orcid.ico)
(Hospital Universitario San Juan de Alicante)
Trescolí, Carlos (Hospital Universitari de la Ribera (València))
Ena, Javier ![Identificador ORCID](/img/uab/orcid.ico)
(Hospital Marina Baixa (La Vila Joiosa, Alacant))
Borrell, Mireia
(Sanofi)
Gomez Huelgas, Ricardo (Instituto de Investigación Biomédica de Málaga)
Universitat Autònoma de Barcelona
Fecha: |
2020 |
Resumen: |
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. |
Derechos: |
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Lengua: |
Anglès |
Documento: |
Article ; recerca ; Versió publicada |
Materia: |
Blood glucose ;
Hypoglycemia ;
Insulin glargine ;
Diabetes mellitus ;
Type 2 |
Publicado en: |
BMJ open diabetes research and care, Vol. 8 (september 2020) , ISSN 2052-4897 |
DOI: 10.1136/bmjdrc-2020-001518
PMID: 32928792
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Registro creado el 2022-02-07, última modificación el 2023-11-30