Indirect Treatment Comparison (ITC) of ULTRA-RAPID Lispro Insulin (URLI) Versus FAST-Acting Insulin Aspart (FASTER ASPART) in Patients with Type 1 Diabetes (T1DM)
Author(s)
Osumili B1, Paczkowski R2, Spaepen E3, Liao B2, Tobian J2
1Eli Lilly and Company, UK, BRC, UK, 2Eli Lilly and Company, Indianapolis, IN, USA, 3HaaPACS GmbH, Schriesheim, IN, Germany
Presentation Documents
OBJECTIVES : An ITC was performed to estimate between-treatment differences in the efficacy and safety of URLi and faster aspart in adults with T1DM. METHODS : A systematic literature search identified randomised controlled trials examining the efficacy and safety of URLi or faster aspart. No head-to-head trials of these insulins were identified. Key trials identified for URLi (PRONTO-T1D; URLi versus insulin lispro) and faster aspart (onset 1 and 8; faster aspart versus insulin aspart), with basal insulin, reported the endpoints (including primary endpoints) at 26 weeks. The Bucher method was used to perform ITC; clinical equivalence was assumed for the insulin lispro and insulin aspart treatment arms (ITC anchor point). ITC endpoints included changes from baseline in HbA1c, post-prandial glucose (PPG) excursions (1 to 4 hours, following a mixed-meal tolerance test), weight, and incidence of severe hypoglycaemia. RESULTS : ITC of URLi versus faster aspart showed a mean difference (MD) of 0.01% (95% confidence interval [CI] -0.09%; 0.11%) for HbA1c change from baseline at 26 weeks; the 95% CI was within the non-inferiority margin (0.4%). Reduction in PPG excursions (mmol/L) were larger with URLi versus faster aspart at all timepoints, statistically significantly greater from 2 hours onwards (MD: 2 hours, -1.22 [-1.93; -0.51] p<0.01; 3 hours, -1.41 [-2.19; -0.64] p<0.01; 4 hours, -0.87 [-1.66; -0.09] p=0.03). No significant between-treatment differences were observed regarding weight increase (treatment difference -0.36 [-0.81; 0.10] kg) or odds and probability of severe hypoglycaemia (odds ratio for URLi versus faster aspart: 1.08 [0.55, 2.12], risk ratio 1.07 [0.57; 2.03]). CONCLUSIONS : URLi demonstrated non-inferiority in lowering HbA1c at week 26 and superiority in reducing PPG excursions at 2, 3 and 4 hours versus faster aspart in adults with T1DM. Weight increase and severe hypoglycaemia did not differ significantly between URLi and faster aspart.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PDB6
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Diabetes/Endocrine/Metabolic Disorders