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Follow-on biologic insulin lispro safe, effective in type 1 diabetes
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Patients with type 1 diabetes on multiple daily injection therapy assigned a follow-on biologic rapid-acting insulin for 1 year, in combination with insulin glargine, experienced a reduction in HbA1c and fasting plasma glucose that was similar to patients assigned to insulin lispro, according to findings published in Diabetes Technology and Therapeutics.
In the first study evaluating long-term use of a follow-on biologic rapid-acting insulin, researchers also observed no between-group differences in hypoglycemia, other treatment-related adverse events or anti-insulin antibodies.
“This is the first follow-on to insulin lispro (Humalog, Eli Lilly) that shows similar efficacy and safety to the original,” Satish Garg, MD, professor of medicine and pediatrics at the University of Colorado Denver, told Endocrine Today. “Let us hope that this will help patients, once approved by the FDA, in terms of [insulin] cost, which is increasing exponentially.”
A follow-on biologic insulin product has an identical amino acid sequence, but is not considered to be a biosimilar due to its FDA regulatory submission pathway via the federal Food, Drug and Cosmetic Act. No insulin products are currently licensed under the Public Health Service Act; insulins are approved and regulated as chemical drugs, so there is no “reference product” for a proposed biosimilar, according to the FDA.
Garg and colleagues analyzed data from 507 patients with type 1 diabetes who were treated before screening with a multiple daily injection therapy of insulin lispro or insulin aspart (NovoLog, Novo Nordisk) in combination with insulin glargine (Lantus, Sanofi), as part of the phase 3 SORELLA 1 study, a multicenter, two-arm, parallel-group, open-label randomized controlled trial. Participants were randomly assigned to insulin lispro (n = 254) or SAR342434 (n = 253), a follow-on biologic to insulin lispro (mean age, 43 years; mean BMI, 26 kg/m²; mean diabetes duration, 19.05 years). At screening, 60.9% of patients had an HbA1c of at least 8%. At baseline, all participants were using insulin glargine; 60.6% had used insulin lispro in the 6 months before screening. The study consisted of a 26-week period to evaluate the primary efficacy endpoint of change in HbA1c from baseline to week 26, followed by a 26-week safety extension period. Follow-up visits occurred at weeks 4, 8, 12, 20 and 26, and weeks 40 and 52 for the extension period.
During the first 26 weeks, HbA1c decreased similarly in both insulin groups; the least squares mean change in HbA1c from baseline to week 26 was –0.47% for insulin lispro and –0.42% for the follow-on biologic. In both groups, the decrease in HbA1c occurred during the first 12 weeks, remaining stable through week 26; a small increase in HbA1c occurred in both groups between weeks 26 and 52, according to researchers.
Additionally, FPG also decreased in both groups at similar rates. At week 52, least squares mean change was –0.12 mmol/L for insulin lispro and –0.07 mmol/L for the follow-on biologic. The 7-point self-monitored blood glucose profiles for both groups improved at week 52 when compared with baseline, according to researchers.
In both groups, researchers observed similar rates of hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia; a similar percentage in both groups reported treatment-related adverse events, the most common of which was nasopharyngitis. – by Regina Schaffer
Disclosures: Sanofi funded this study. Garg reports receiving consulting fees or research grants from Dario, Eli Lilly, JDRF, Lexicon, Medtronic, Merck, NCI, Novo Nordisk, Roche, Sanofi and T1D Exchange. Three authors are employees and shareholders of Sanofi; one author reports serving as an investigator in clinical trials sponsored by Bayer, Eli Lilly, Merck, Novo Nordisk, Pfizer and Sanofi.
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