Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus
Por:
Freemantle, N, Mauricio, D, Giaccari, A, Bailey, T, Roussel, R, Franco, D, Berthou, B, Pilorget, V, Westerbacka, J, Bosnyak, Z, Bonnemaire, M, Cali, AMG, Nguyen-Pascal, ML, Penfornis, A, Perez-Maraver, M, Seufert, J, Sullivan, SD, Wilding, J, Wysham, C, Davies, M, REACH Investigator, REGAIN Investigator
Publicada:
2 abr 2020
Ahead of Print:
1 ene 2020
Resumen:
Objective: To compare real-world outcomes with newer (insulin glargine 300 U/mL; Gla-300) versus standard of care (SoC) basal insulins (BIs) in the REACH (insulin-naive; NCT02967224) and REGAIN (basal insulin-treated; NCT02967211) studies in participants with uncontrolled type 2 diabetes (T2DM) in Europe and Brazil. Methods: In these open-label, parallel-group, pragmatic studies, patients (HbA(1c) > 7.0%) were randomized to Gla-300 or SoC BI for a 6-month treatment period (to demonstrate non-inferiority of Gla-300 vs SoC BIs for HbA(1c) change [non-inferiority margin 0.3%]) and a 6-month extension period (continuing with their assigned treatment). Insulin titration/other medication changes were at investigator/patient discretion post-randomization. Results: Overall, 703 patients were randomized to treatment in REACH (Gla-300, n = 352; SoC, n = 351) and 609 (Gla-300, n = 305, SoC, n = 304) in REGAIN. The primary outcome, non-inferiority of Gla-300 versus SoC for HbA(1c) change from baseline to month 6, was met in REACH (least squares [LS] mean difference 0.12% [95% CI -0.046 to 0.281]) but not REGAIN (LS mean difference 0.17% [0.015-0.329]); no between-treatment difference in HbA(1c) change was shown after 12 months in either study. BI dose increased minimally from baseline to 12 months in REACH (Gla-300, +0.17 U/kg; SoC, +0.15 U/kg) and REGAIN (Gla-300, +0.11 U/kg; SoC, +0.07 U/kg). Hypoglycemia incidence was low and similar between treatment arms in both studies. Conclusions: In both REACH and REGAIN, no differences in glycemic control or hypoglycemia outcomes with Gla-300 versus SoC BIs were seen over 12 months. However, the suboptimal insulin titration in REACH and REGAIN limits comparisons of outcomes between treatment arms and suggests that more titration instruction/support may be required for patients to fully derive the benefits from newer basal insulin formulations.
Filiaciones:
Freemantle, N:
UCL, Inst Clin Trials & Methodol, 90 High Holborn, London WC1V 6LJ, England
Mauricio, D:
Hosp Santa Creu & Sant Pau, Dept Endocrinol & Nutr, CIBERDEM, Barcelona, Spain
Giaccari, A:
Univ Cattolica Sacro Cuore, Fdn Policlin Univ A Gemelli IRCSS, Ctr Endocrine & Metab Dis, Rome, Italy
Bailey, T:
AMCR Inst, Escondido, CA USA
Roussel, R:
Hop Xavier Bichat, AP HP, Dept Diabetol Endocrinol & Nutr, Paris, France
Ctr Rech Cordeliers, INSERM U1138, Paris, France
Paris Univ, UFR Med, Paris, France
Franco, D:
CPCLIN Clin Res Ctr, Sao Paulo, Brazil
Berthou, B:
IT&M Stats, Paris, France
Pilorget, V:
Sanofi, Chilly Mazarin, France
Westerbacka, J:
Sanofi, Paris, France
Bosnyak, Z:
Sanofi, Paris, France
Bonnemaire, M:
Sanofi, Paris, France
Cali, AMG:
Sanofi, Paris, France
Nguyen-Pascal, ML:
Sanofi, Chilly Mazarin, France
Penfornis, A:
Sud Francilien Hosp, Dept Diabet, Corbeil Essonnes, France
Univ Paris Sud, Paris, France
Perez-Maraver, M:
Hosp Univ Bellvitge, IDIBELL, Serv Endocrinol & Nutr, Barcelona, Spain
Seufert, J:
Univ Freiburg, Univ Hosp Freiburg, Dept Med 2, Fac Med,Div Endocrinol & Diabetol, Freiburg, Germany
Sullivan, SD:
Univ Washington, Sch Pharm, CHOICE Inst, Seattle, WA 98195 USA
Wilding, J:
Univ Liverpool, Inst Ageing & Chron Dis, Obes & Endocrinol Clin Res, Liverpool, Merseyside, England
Wysham, C:
Multicare Rockwood Clin, Diabet & Endocrinol Ctr, Spokane, WA USA
Davies, M:
Univ Leicester, Leicester Gen Hosp, Diabet Res Ctr, Leicester, Leics, England
Hybrid Gold, Green Published
|