Exploring the risk for severe hypoglycemia in the pool of studied patients with T1D

Objective¹

This meta-analysis explores the risk for severe hypoglycemia with Gla-300 versus Gla-100 in the pool of studied patients with T1D.

Study Design

The following patients with T1D were pooled in the present study:

EDITION 4 (n=549): adult patients (age ≥18 years), worldwide²
EDITION JP 1 (n=243): adult patients (age ≥18 years), Japan³
EDITION JUNIOR (n=463): children and adolescents (age 6−17 years), worldwide⁴

Previous Basal Insulin⁴

Results¹

Gla-300 provides effective and similar glycemic control versus Gla-100 in patients with T1D -0.3% HbA1c reduction LSM difference at week 26 (95% CI): 0.05% (-0.044 to 0.150)

Significant Lower percentage of patients with ≥1 Severe Hypoglycemic event with Gla-300 vs. Gla-100 from baseline to month 6 in pooled analysis -35% From baseline to month 6: OR (95% CI): 0.65 (0.42 to 0.98)

Conclusion¹

Gla-300 showed a lower risk for severe hypoglycemia compared with Gla-100 in a broad spectrum of patients with T1D, especially during the titration phase.
Gla-300 provides effective and similar glycemic control versus Gla-100 in patients with T1D.

Gla-300, insulin glargine 300 U/ml; Gla-100, insulin glargine 100U/ml; T1D, type 1 diabetes; IDet, insulin detemir; NPH, Neutral Protamine Hagedorn insulin; IDeg, insulin degludec; CI, confidence interval; LS, least square; SE, standard error

Danne T, et al. PediatrDiabetes 2019;20 (Suppl28):P236. Poster presented at 45th Annual Conference for the International Society for Pediatric and Adolescents Diabetes (ISPAD) Boston 2019 –P236
Home, P., Bergenstal, R., Bolli, G., Ziemen, M., Rojeski, M., Espinasse, M. and Riddle, M., 2015. New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 1 Diabetes: A Randomized, Phase 3a, Open-Label Clinical Trial (EDITION 4). Diabetes Care, 38(12), pp.2217-2225.
Matsuhisa, M., Koyama, M., Cheng, X., Takahashi, Y., Riddle, M., Bolli, G. and Hirose, T., 2016. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and meal􀆟me insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes, Obesity and Metabolism, 18(4), pp.375-383.
Danne, T., Tamborlane, W., Malievsky, O., Franco, D., Kawamura, T., Demissie, M., Niemoeller, E., Goyeau, H., Wardecki, M. and Batielino, T., 2020. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care, 43(7), pp.1512-1519.