LOWER RISK FOR SEVERE HYPOGLYCEMIA WITH GLA-300 VS. GLA-100 IN PATIENTS WITH TYPE 1 DIABETES (T1D): A META-ANALYSIS OF 6-MONTH PHASE 3 CLINICAL TRIALS
- Thomas Danne, Germany
- Thomas Danne, Germany
- Munehide Matsuhisa, Japan
- Christian Sussebach, Germany
- Harmonie Goyeau, France
- Felipe Lauand, France
- Elisabeth Niemöller, Germany
- Geremia B. Bolli, Italy
Abstract
Background and Aims
In this post hoc meta-analysis 6-month data sets from three randomised controlled open-label phase 3 trials with insulin glargine 300 U/ml (Gla-300) versus insulin glargine 100 U/ml (Gla-100) in patients with T1D were pooled for analysis of severe hypoglycaemia.
Methods
All trials were similarly designed and achieved their primary endpoint of HbA1c non-inferiority of Gla-300 versus Gla-100. EDITION 4 (n=549) and JUNIOR (n=463) were conducted worldwide and EDITION JP1 (n=243) was conducted in Japan. EDITION 4 and EDITION JP1 studied adults aged ≥18 years; JUNIOR enrolled participants aged 6–17 years. In total, 629 participants received Gla-300 and 624 received Gla-100 together with prandial insulin. Severe hypoglycemia was defined in adults as a hypoglycaemic event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, and in children and adolescents as having altered mental status and inability to assist in their care, being semiconscious or unconscious, or in coma ± convulsions requiring possible parenteral therapy (glucagon and/or glucose).
Results
During the 6-month treatment period fewer patients experienced severe hypoglycaemic events with Gla-300 (n=39, 6.2%) versus Gla-100 (n=58, 9.3%); Odds Ratio 0.65 (95% CI 0.42–0.98). The Kaplan–Meier plot (Stratified Log-rank-Test: p=0.038) demonstrated persistence of risk reduction over time (Figure). Similarly, the event rate for severe hypoglycaemia was numerically lower with Gla-300 versus Gla-100 (0.23 vs 0.29 events/patient-year; Relative Risk 0.80, 95% CI 0.49–1.29).
Conclusions
Gla-300 showed a lower risk for severe hypoglycemia compared to Gla-100 in people with T1D.