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Similar Efficacy and Safety of LY2963016 Insulin Glargine and Insulin Glargine (Lantus®) in Patients with T2D in Age Groups (< 65 Yrs, = 65 Yrs)
In elderly patients with type 2 diabetes, according to results of an analysis of the ELEMENT-2 phase 3 study, the efficacy and safety profile of LY2963016 insulin glargine (LY IGlar) is similar to that of insulin glargine (Lantus®; IGlar). LY IGlar is the first “follow-on” insulin glargine product to be approved in the United States and the first biosimilar insulin approved in the European Union and Japan, said Robyn Pollom, NP, senior research scientist, Eli Lilly, Indianapolis, IN, at her 2016 American Diabetes Association poster presentation.
While the similarity of LY IGlar to IGlar has already been demonstrated in prior research with respect to pharmacokinetics and pharmacodynamics, and clinically in patients with type 1 diabetes (ELEMENT-1) and type 2 diabetes (ELEMENT-2), diabetes management priorities and treatment choices may differ between older and younger patients. To determine whether differences exist in the safety and efficacy profiles of LY IGlar and IGlar in older adults (≥65 years) as compared with patients <65 years with type 2 diabetes, investigators examined data from this population in ELEMENT-2, a randomized, double-blind, 24-week study of a patient-driven titration schedule. In that schedule, patients added 1 unit of basal insulin per day until they attained fasting plasma glucose (FPG) levels of ≤100 mg/dL (5.6 mmol/L).
Prespecified analyses included changes from baseline in HbA1c , body weight, and hypoglycemia (total, severe and nocturnal). Adverse events, and treatment-emergent antibody response were evaluated, as well.
The analysis included 214 patients ≥65 years (mean age 70.42 years) and 542 patients <65 years (mean age 54.25 years). Mean baseline BMI was 30.70 in the ≥65 group and 32.37 in the <65 group (p<0.001). Mean baseline HbA1c was 8.06 and 8.43 in the ≥65 and <65 groups, respectively (p<0.001). Older subjects were more likely to be taking basal insulin (45.3% versus 37.3 percent, p=0.047).
At 24 weeks, differences in changes from baseline between LY IGlar and IGlar in HbA1c were nonsignificant in both groups (≥65: Δ=0.028, p=0.814; <65: Δ=0.083, p=0.262). Also, FBG by self-monitored blood glucose at week 24 was similar for LY IGlar and IGlar in both age groups, as was body weight. At week 24, basal insulin dose went up similarly for both agents and in both age groups.
Severe hypoglycemia could not be assessed because there were insufficient events in each treatment arm. Otherwise, total documented symptomatic hypoglycemia and nocturnal hypoglycemia had similar incidence and rates for both insulins and in both age groups.
Treatment-emergent adverse events were reported among 56.3% and 54.9% of patients ≥65 receiving LY IGlar/IGlar, respectively (NS), and in 50.4% and 46.0% of patients <65 receiving LY IGlar/IGlar, respectively (NS).
Ms. Pollom summarized, “No significant treatment differences were observed within each age group for any of the clinical efficacy and safety outcomes, and no significant treatment interactions were observed for any of the clinical efficacy and safety outcomes. LY IGlar and IGlar exhibit similar efficacy and safety in patients with type 2 diabetes who are ≥65 years and in those <65 years.”
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