Article Text
Abstract
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.
- blood Glucose
- hypoglycemia
- insulin glargine
- diabetes mellitus
- type 2
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Footnotes
Presented at This study was presented at the 38th Spanish Society of Internal Medicine (SEMI) Congress (22–24 November 2017; Madrid, Spain); the XXIX Spanish Society of Diabetes (SED) Congress (18–20 April 2018; Oviedo, Spain); the XXXIX SEMI Congress (21–23 November 2018; Burgos, Spain); the XXX SED Congress (24–26 April 2019; Seville, Spain); and the XXXX SEMI Congress (27–29 November 2019; Barcelona, Spain).
Collaborators The following investigators of the COBALTA study group also collaborated in the study: Raquel Díaz (Hospital Universitario 12 Octubre, Madrid, Spain); Antonio Lalueza (Hospital Universitario 12 Octubre, Madrid, Spain); María Soto (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); Mariano Aguayo (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); Juana García (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); Silvia Herrojo (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); María Ángeles García (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); Alicia Hidalgo (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); Esther Ortiz (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); Anabel Ostos (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); Inmaculada Páez (Hospital Universitario Juan Ramón Jiménez, Huelva, Spain); Patricia Platero (Hospital Universitario de La Ribera, Alzira, Spain); Andrea Pérez (Hospital Universitario de La Ribera, Alzira, Spain); José Luis Díaz (Hospital Abente y Lago, A Coruña, Spain); Sonia Ruanova (Hospital Abente y Lago, A Coruña, Spain); Patricia Vázquez (Hospital Abente y Lago, A Coruña, Spain); María Dolores López (Hospital Regional Universitario de Málaga, Málaga, Spain); Sergio Jesús Jansen (Hospital Regional Universitario de Málaga, Málaga, Spain); María Guil (Hospital Regional Universitario de Málaga, Málaga, Spain); Miguel Marcos (Hospital Universitario de Salamanca, Salamanca, Spain); Antonio Javier Chamorro (Hospital Universitario de Salamanca, Salamanca, Spain); Silvio Ragozzino (Hospital Universitario de Salamanca, Salamanca, Spain); Hugo Ternavasio (Hospital Universitario de Salamanca, Salamanca, Spain); Cristina Carbonell Muñoz (Hospital Universitario de Salamanca, Salamanca, Spain); Domingo Acosta (Hospital Universitario Virgen del Rocío, Seville, Spain); Antonio Jesús Martínez (Hospital Universitario Virgen del Rocío, Seville, Spain); Fermín Javier Jiménez (Complejo Hospitalario de Navarra, Pamplona, Spain); Vanesa Antoñana (Complejo Hospitalario de Navarra, Pamplona, Spain); Judith Poblet (Complejo Hospitalario de Navarra, Pamplona, Spain); Lander Badiola (Complejo Hospitalario de Navarra, Pamplona, Spain); David Pérez (Complejo Hospitalario de Navarra, Pamplona, Spain); Leire Huete (Complejo Hospitalario de Navarra, Pamplona, Spain); Cristóbal Morales (Hospital Universitario Virgen de la Macarena, Seville, Spain); Mariola Méndez (Hospital Universitario Virgen de la Macarena, Seville, Spain); Ignacio Jiménez (Hospital Universitario Virgen de la Macarena, Seville, Spain); Miriam Romero (Hospital Universitario Virgen de la Macarena, Seville, Spain); María Riestra (Hospital de Cabueñes, Gijón, Spain); Joaquín Morís (Hospital de Cabueñes, Gijón, Spain); Mercedes Cadenas (Hospital de Cabueñes, Gijón, Spain); Florentino Casal (Hospital de Cabueñes, Gijón, Spain); Brenda Veiguela (Hospital de Cabueñes, Gijón, Spain); Joaquín Antón (Hospital San Pedro de Alcántara, Cáceres, Spain); José Manuel García (Hospital Quironsalud Málaga, Málaga, Spain); Ana María Gómez (Hospital Quironsalud Málaga, Málaga, Spain); Rosario Fernández (Hospital Quironsalud Málaga, Málaga, Spain); Isabel Cornejo (Hospital Quironsalud Málaga, Málaga, Spain); Analía Emilce Ramos (Hospital de la Santa Creu i Sant Pau, Barcelona, Spain); Pedro Gil (Hospital de la Santa Creu i Sant Pau, Barcelona, Spain).
Contributors AP contributed to the study design, conduct/data collection, analysis and writing of the manuscript. FJC-S, JE and RGH contributed to the study design, conduct/data collection and writing of the manuscript. MB contributed to the study design, analysis and writing the manuscript. The remaining authors contributed to the conduct of the study/data collection and writing of the manuscript. All authors gave final approval of the version to be published, participated sufficiently in the work to take public responsibility for appropriate portions of the content and agreed to be accountable for all aspect of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding Financial support for the present study was provided by Sanofi, which was involved in the study design; in the collection, analysis and interpretation of the data; in the writing of the report; and in the decision to submit the paper for publication. Medical writing support was provided by Esther Álvarez-García and Antonio Torres-Ruiz at Dynamic Science S.L. during the preparation of this paper, funded by Sanofi.
Competing interests This work was funded by Sanofi. MB is employed by and has ownership interest in Sanofi. AP has received personal consulting fees and/or speaker honoraria or travel expenses from Sanofi Aventis, Almirall, Novo Nordisk, Eli Lilly, MSD, Boehringer Ingelheim, Esteve, Novartis, Amgen, Menarini, and Astra Zeneca. The remaining authors have no conflict of interest to disclose.
Patient consent for publication Not required.
Ethics approval This study was approved by the ethics committee of the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain; 15/320 (R)), and all patients gave their written informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. Qualified researchers may request access to patient-level data and related study documents, including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found online (https://www.clinicalstudydatarequest.com).