-- Companies present comprehensive data for LY2963016, new insulin glargine product
SAN FRANCISCO, June 14, 2014 /PRNewswire/ -- For the first time today, Eli Lilly and Company and Boehringer Ingelheim presented data showing that LY2963016, the alliance's investigational new insulin glargine product, has a similar safety and efficacy profile to currently marketed insulin glargine (Lantus()).(1,2,3,4,5,6) Results from these Phase I and Phase III studies were presented at the 74(th) American Diabetes Association Scientific Sessions in San Francisco.
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"Results from six completed clinical trials for this new insulin glargine product showed that it works similarly in the body and produces clinical results similar to Lantus," said Tom Blevins, M.D., endocrinologist with Texas Diabetes & Endocrinology, Austin, TX. "These data are important because Lilly/BI's insulin glargine could serve as an important treatment option in the future when physicians are deciding on an insulin glargine product to help patients meet their treatment goals."
LY2963016 insulin glargine is an investigational basal insulin that is intended to provide long-lasting blood sugar control between meals and at night, an integral part of glycaemic control.(7) It has the same amino acid sequence as Lantus() and, in most geographic regions, will be submitted for approval as a biosimilar. As the term is a regulatory designation, LY2963016 insulin glargine is considered a biosimilar in some regions but not in others, including the United States.
"Lilly and BI are pleased to share our new insulin glargine data with the medical community," said Gwen Krivi, Ph.D., vice president, Lilly Diabetes Development. "Our LY2963016 insulin glargine data package has been submitted to several global regulatory agencies, including the U.S., Europe and Japan. This is one step closer to providing an important insulin glargine option to physicians and patients."
Phase III Study Results
In patients with type 1 and type 2 diabetes, LY2963016 insulin glargine was compared to currently marketed insulin glargine, and both products led to significant decreases in average blood glucose levels (HbA1c). LY2963016 insulin glargine demonstrated non-inferiority compared to marketed insulin glargine, and marketed insulin glargine demonstrated non-inferiority to LY2963016 insulin glargine.(4,5)
--- Patients with type 1 diabetes had HbA1c reductions of -0.4 percent
(LY2963016 insulin glargine) and -0.5 percent (marketed insulin
glargine) at 24 weeks, with similar results at 52 weeks (-0.3 percent
for both insulin glargine treatments).(4)
-- Patients with type 2 diabetes had HbA1c reductions of -1.3 percent in
both insulin glargine treatment groups at 24 weeks.(5 )
Approximately one-third of patients with type 1 diabetes reached target HbA1c levels of less than 7 percent at 24 weeks with LY2963016 insulin glargine (35 percent) and marketed insulin glargine (32 percent) treatment.(4) In patients with type 2 diabetes, about half of patients reached these target levels with LY2963016 insulin glargine (49 percent) and marketed insulin glargine (53 percent) treatment.(5)
In patients with type 1 diabetes, the incidence of adverse events at 52 weeks was the same between the two insulin treatments (62 percent). The total average hypoglycaemia rate (having symptoms attributable to a low blood sugar level and/or blood glucose less than or equal to 70 mg/dL) at 24 weeks was also similar between LY2963016 insulin glargine and marketed insulin glargine (87 and 89 events/patient/year, respectively).(4)
The frequency of adverse events was similar between the two treatments in patients with type 2 diabetes (52 percent and 48 percent, LY2963016 insulin glargine and marketed insulin glargine, respectively), including the total average hypoglycaemia rate (21 vs. 22 events/patient/year, LY2963016 insulin glargine and marketed insulin glargine, respectively).(5)
The Phase III studies also evaluated whether LY2963016 insulin glargine and marketed insulin glargine led to similar development of insulin antibodies and similar effects of immune responses on clinical outcomes. Results showed a similar immunogenicity profile of LY2963016 insulin glargine to marketed insulin glargine.
--- The proportion of patients with type 1 diabetes with detectable
anti-insulin antibodies was similar between LY2963016 insulin glargine
and marketed insulin glargine at baseline (17 percent and 21 percent,
respectively) and throughout treatment to 52 weeks (40 percent and 39
percent, respectively).
-- The proportion of patients with type 2 diabetes with detectable insulin
antibodies was similar between LY2963016 insulin glargine and marketed
insulin glargine at baseline (6 percent and 4 percent, respectively) and
throughout treatment to 24 weeks (15 percent and 11 percent,
respectively).
-- Clinical outcomes, including HbA1c levels, basal insulin dose and total
hypoglycaemia levels, were not affected by whether or not patients
developed antibodies response during the study.(6)
Phase I Study Results
Results from Phase I studies showed that LY2963016 insulin glargine and marketed insulin glargine have similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles, meaning that LY2963016 insulin glargine, when injected under the skin, provided the same amount of insulin in the blood, with similar characteristics and insulin action (how insulin works to control blood glucose levels), compared to marketed insulin glargine.(1,2 )
--- The PK and PD of LY2963016 insulin glargine and the EU- and US-approved
versions of insulin glargine were compared in three studies of healthy
participants who received 0.5U/kg doses of two different insulin
glargine products on two separate occasions. Results showed similar PK
and PD properties of LY2963016 insulin glargine and marketed insulin
glargine.(1 )
-- The PK and PD properties were similar between LY2963016 insulin glargine
and marketed insulin glargine and were consistent across both
administered doses in a study comparing the two insulin treatments at
two different doses (0.3 and 0.6 U/kg) in healthy participants.(2)
In these Phase I studies, LY2963016 insulin glargine was well-tolerated, with no safety concerns noted in adverse events, clinical laboratory tests, vital signs or ECG data. The frequency of adverse events reported was similar between the two treatments.(1,2 )
A further Phase 1 study assessed LY2963016 insulin glargine's duration of action (how long the insulin works to control blood glucose levels) in patients with type 1 diabetes. Results showed that the average duration of action was 24 and 26 hours for LY2963016 insulin glargine and marketed insulin glargine, respectively. LY2963016 insulin glargine was well-tolerated, with no safety concerns noted in adverse events, clinical laboratory tests, vital signs or ECG data. The frequency of adverse events reported was similar between the two treatments.(3)
About the Phase III Studies
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