Biosimilar insulin lispro shown not inferior to Humalog in efficacy or safety

August 9, 2017
Credit: Mary Ann Liebert, Inc., publishers

A study comparing the safety and efficacy of SAR342434, a biosimilar (follow-on form) of insulin lispro-Humalog, found it to be comparable to that of the brand name drug in patients also using insulin glargine. The phase 3, randomized SORELLA 1 trial evaluated changes in HbA1c, fasting plasma glucose, and self-monitored plasma glucose levels, as well as hypoglycemic events, and the results are published in Diabetes Technology & Therapeutics.

Coauthors Satish Garg, University of Colorado Denver (Aurora), Karin Wernicke-Panten and Yvonne Kirchhein, Sanofi-Aventis Duetschland (Frankfurt, Germany), Maria Rojeski, Sanofi (Bridgewater, NJ), Suzanne Pierre, Sanofi (Paris, France), and Krystyna Jedynasty, Centrum Diabetologiczne (Warsaw, Poland) collaborated on the article entitled "Efficacy and Safety of Biosimilar (SAR342434 Insulin Lispro) in Adults with Type 1 Diabetes also Using Insulin Glargine—SORELLA 1 Study."

Throughout the 6-month main study and additional 6-month extension period, the incidence and prevalence of hypoglycemia, treatment-emergent adverse events, and anti- antibodies did not differ significantly between the two treatment groups.

"This is the first long-term study of biosimilar (follow-on) rapid-acting insulin (insulin lispro), evaluated for 1 year, which clearly shows the safety and efficacy of the biosimilar insulin being similar to the original insulin," says DTT Editor-in-Chief Satish Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver (Aurora). "The costs of insulin products have skyrocketed, especially in the U.S. The availability of biosimilars will reduce the cost of insulin and make it possible for more patients with diabetes to reach target HbA1c values."

Explore further: Risks of diabetics fasting during Ramadan: Hypoglycemia rates with insulin pump v. injections

More information: Satish Garg et al, Efficacy and safety of Biosimilar (SAR342434 insulin lispro) in adults with type 1 diabetes also using insulin glargine-SORELLA 1 study, Diabetes Technology & Therapeutics (2017). DOI: 10.1089/dia.2017.0117

Related Stories

Risks of diabetics fasting during Ramadan: Hypoglycemia rates with insulin pump v. injections

April 7, 2017
A new study examining the risk of fasting during Ramadan for people with type 1 diabetes compared blood glucose control and the rates of hypoglycemia and hyperglycemia between users of insulin pump therapy versus multiple ...

Studies compare types of insulin for reducing episodes of low blood sugar for patients with Type 1 or 2 diabetes

July 3, 2017
Treatment with the insulin degludec compared to glargine U100 for 32 weeks resulted in a reduced rate of hypoglycemic (low blood sugar) episodes among patients with type 1 or 2 diabetes and at least one risk factor for hypoglycemia, ...

Home use of hybrid closed-loop insulin delivery system shown safe and effective

February 13, 2017
A pivotal registration trial to evaluate in-home use of the Medtronic MiniMed 670G hybrid closed-loop insulin delivery system over 3 months showed a significant reduction in HbA1c levels for both adolescents and adults with ...

Basal insulin peglispro beats glargine for glycemic control

November 30, 2015
(HealthDay)—For patients with type 2 diabetes, basal insulin peglispro (BIL) provides better glycemic control than insulin glargine, with increased triglycerides, aminotransferases, and liver fat content, according to a ...

Clinical efficacy and future development of continuous glucose monitoring highlighted in DTT

June 7, 2017
A growing body of data from clinical studies of continuous glucose monitoring (CGM) in type 1 diabetes supports the value of CGM for reducing variability in blood glucose levels and the risks of both hypo- and hyperglycemia, ...

Case report describes insulin autoimmune syndrome

May 7, 2017
(HealthDay)—In a case report published online May 1 in Diabetes Care, resolution of hypoglycemia and cardiovascular dysfunction after rituximab treatment of insulin autoimmune syndrome is described.

Recommended for you

Smart mat detects early warning signs of foot ulcers

August 16, 2017
While completing his residency in anesthesiology at Massachusetts General Hospital in the mid-2000s, Jon Bloom saw his fair share of foot amputations among patients with diabetes. The culprit: infected foot ulcers.

The best place to treat type 1 diabetes might be just under your skin

August 14, 2017
A group of U of T researchers have demonstrated that the space under our skin might be an optimal location to treat type 1 diabetes (T1D).

New measure of insulin-making cells could gauge diabetes progression, treatment

August 10, 2017
Researchers at the University of Wisconsin-Madison have developed a new measurement for the volume and activity of beta cells, the source of the sugar-regulating hormone insulin.

Pioneering immunotherapy shows promise in type 1 diabetes

August 9, 2017
It may be possible to 'retrain' the immune system to slow the progression of type 1 diabetes, according to results of a clinical trial published today in the journal Science Translational Medicine.

Online team-based game helps patients with diabetes lower blood glucose

August 8, 2017
Researchers from Brigham and Women's Hospital and the Veterans Affairs Boston Healthcare System have found that an online, team-based game designed to teach patients about diabetes self-management had a sustained and meaningful ...

Oxidative stress biomarkers don't always signal diabetes risk

August 7, 2017
High levels of compounds found in the body that are commonly associated with oxidative damage may actually be a good sign for some people, according to a recent review of multiple human studies led by an epidemiologist at ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.