Insulin aspart biosimilar safe for pump therapy use in type 1 diabetes
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A follow-on therapy to insulin aspart was shown to be safe and effective for pump use among adults with type 1 diabetes, with no increased incidence of unexplained hypoglycemia when compared with the reference product, according to findings from an open-label crossover study published in Diabetes Technology & Therapeutics.
“This study of a follow-on rapid-acting insulin aspart SAR341402 vs. insulin aspart Novolog, when used in people with type 1 diabetes via an insulin pump, showed similar primary outcomes of infusion set occlusions,” James Thrasher, MD, FACE, a partner at Arkansas Diabetes and Endocrinology Center and president of Medical Investigations Inc., a private research center, told Healio. “The two were similar in tolerability as seen in secondary safety outcomes, such as hypoglycemia and adverse events.”
Follow-on insulin aspart SAR341402 (100 U/mL; Sanofi) has the same amino acid sequence and corresponding structure as the currently approved insulin aspart reference product (NovoLog, Novo Nordisk) and is being developed as a biosimilar insulin in accordance with relevant U.S. and European Union guidelines, the researchers wrote in the study background.
In a randomized, open-label, crossover study, Thrasher and colleagues analyzed data from 45 adults with type 1 diabetes using insulin pump therapy for at least 6 months (mean age, 43 years; 28 women; 41 white). Median diabetes duration was 22.7 years, and median duration of pump therapy was 8.2 years (91.1% using Medtronic pumps). Researchers randomly assigned participants to follow-on insulin aspart (3 mL cartridge) for 4 weeks during the first treatment period, followed by NovoLog (3 mL PenFill) for 4 weeks during the second treatment period, or vice versa. Participants used their own insulin infusion pumps; doses were individually titrated and self-administered as required. There was no washout period between treatments. Primary outcome was the number of participants with at least one infusion set occlusion, defined as an infusion set change due to failure-to-correct hyperglycemia by insulin pump bolus, during the 4-week treatment. The main secondary outcome was the number of participants with at least one episode of unexplained hyperglycemia.
The number of participants with at least one infusion set occlusion was similar while receiving insulin aspart biosimilar (14; 32.6%) and Novolog (12; 27.9%). The risk estimate was 32.4% and 28.3% for insulin aspart biosimilar and Novolog, respectively, for a risk difference of 4.1 percentage points (95% CI, –9.3 to 17.4). During the first treatment period, 16 participants experienced at least one infusion set occlusion (nine while receiving follow-on insulin aspart and seven while receiving NovoLog) vs. 10 participants during the second treatment period (five while receiving follow-on insulin aspart and five while receiving NovoLog).
There were no between-group differences in episodes of hypoglycemia, treatment-emergent adverse events, hypersensitivity or injection site reactions.
“The clinical implication for this study is to provide additional safety and tolerability data about a second follow-on insulin when administered via an insulin pump,” Thrasher said. “With more choices for rapid-acting insulin with these follow-on products, this could help alleviate the rising cost of insulin.”
Thrasher said more studies are underway using follow-on insulins as injections, and additional data are needed regarding the safety and tolerability of use with insulin pumps. – by Regina Schaffer
For more information:
James Thrasher, MD, FACE, can be reached at Medical Investigations Inc., 11400 Huron Lane, Little Rock, AR 72211; email: jthrashermd@yahoo.com.
Disclosures: Sanofi funded this study. Thrasher reports he has received advisory or consultant fees from Lexicon, Medtronic, Novo Nordisk, Pfizer and Sanofi, research grants from Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Lexicon, Medtronic, Novo Nordisk and Sanofi, and speaking fees from Amylin, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Janssen, Medtronic, Novo Nordisk, Sanofi and Takeda. Please see the study for all other authors’ relevant financial disclosures.
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