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. 2024 Jul 9;16(1):152.
doi: 10.1186/s13098-024-01385-x.

Effect of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL (Gla-300) in Brazilian people with type 1 diabetes

Patricia Medici Dualib  1   2 , Sergio Atala Dib  3 , Gustavo Akerman Augusto  4 , Ana Cristina Truzzi  5 , Mauricio Aguiar de Paula  5 , Rosângela Roginski Réa  6
Affiliations

Effect of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL (Gla-300) in Brazilian people with type 1 diabetes

Patricia Medici Dualib et al. Diabetol Metab Syndr. .

Abstract

Background: Low adherence to the number of insulin injections and glycemic variability are among the challenges of insulin therapy in type 1 diabetes (T1D). The TOP1 study investigated the effect of switching from twice-daily (BID) basal insulin to once daily (OD) insulin glargine 300 U/mL (Gla-300) on glycemic control and quality of life.

Methods: In this 28-week, phase 4 trial, people with T1D aged ≥ 18 years, who were treated with BID basal insulin in combination with prandial rapid-acting insulin for at least 1 year, and had HbA1c between 7.5% and 10.0%, were switched to Gla-300 OD as basal insulin. The present study aimed to evaluate the impact of this change on HbA1c, glycemic profile, treatment satisfaction and safety. The change in HbA1c from baseline to Week 24 was the primary endpoint.

Results: One hundred and twenty-three people with T1D (mean age 37 ± 11 years; 54.5% female) were studied. The disease duration was 20.0 ± 9.8 years, baseline HbA1c and fasting plasma glucose (FPG) were 8.6 ± 0.7% and 201 ± 80.3 mg/dL, respectively. After switching from BID to OD insulin regimen, no significant change in HbA1c was observed from baseline to Week 24 (p = 0.873). There were significant reductions in fasting self-monitoring blood glucose (SMBG) from baseline to Week 24 (175 ± 42 vs. 156 ± 38 mg/dL; p < 0.0001), and in glycemic profile (8-point SMBG) at several time points. There was a significant decrease in the proportion of patients with at least one hypoglycemic event (p = 0.025), in numbers of hypoglycemic events per patient-years of any type (p = 0.036), symptomatic (p = 0.007), and confirmed ≤ 70 mg/dL events (p = 0.049) from run-in to the last 4 weeks on treatment. There were significant improvements in treatment satisfaction (p < 0.0001), perceived hyperglycemia (p < 0.0001) scores and satisfaction with the number of injections between post-run-in and Week 24, and a significant decrease in fear of hypoglycemia.

Conclusions: Switch from BID basal insulin to OD Gla-300 as part of basal bolus therapy in T1D resulted in similar glycemic control as measured by HbA1c, but provided significant improvements in SMBG, daily glucose profile, a lower incidence of hypoglycemia and increased patient satisfaction.

Trial registration: NCT03406000.

Keywords: Dawn phenomenon; Diabetes mellitus, type 1; Glycemic profile; HbA1c; Hypoglycemia; Insulin glargine; Patient-reported outcomes.

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Conflict of interest statement

PMD declares having no conflicts of interest for this manuscript. SAD declares having no conflicts of interest for this manuscript. GAA declares having no conflicts of interest for this manuscript. ACT was a full-time employee of Sanofi during study conduction. MAP is an employee of Sanofi and hold shares and/or stock options in the company. RRR declares having no conflicts of interest for this manuscript.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Patient flow with regards to eligibility and analysis
See this image and copyright information in PMC

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