Mylan and Biocon have announced the presentation of new data from the insulin glargine clinical program, including the Instride studies at the American Diabetes Association’s 77th Scientific Sessions in San Diego. The studies confirmed the efficacy, safety and immunogenicity of MYL-1501D, insulin glargine, in comparison to Lantus® in patients with Type 1 and Type 2 diabetes. Data demonstrating pharmacokinetic and pharmacodynamic equivalence also was presented.
Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar.
According to Rajiv Malik, president, Mylan, with more than 29 million Americans living with diabetes and the cost of insulin products on the rise, there’s a clear unmet need for more-affordable treatment options for insulin glargine. We are pleased with the positive results of the INSTRIDE clinical program, which demonstrate comparable clinical efficacy and safety of our insulin glargine to Lantus. We have long been deeply committed to supporting this community and advancing treatment for patients as the leading producer of oral diabetes medications in the U.S., and now we are continuing to deliver on our mission through our insulin programs.”
“We are pleased with the outcome of these global clinical studies confirming the safety, efficacy and immunogenicity of our insulin glargine in comparison to the reference product in Type 1 and Type 2 diabetes. This is an important milestone in our development of a more affordable insulin glargine and furthers our mission of enabling access by addressing the needs of diabetes patients globally,” Arun Chandavarkar, CEO & Joint Managing Director, Biocon.
The two Instride studies were randomized, confirmatory clinical trials designed to evaluate comparative efficacy and safety of Mylan’s proposed insulin glargine, MYL-1501D versus branded insulin glargine, Lantus. INSTRIDE1 was a 52-week study in 558 T1DM patients, while INSTRIDE 2 was a 24-week study in 560 T2DM which included insulin-naïve) patients. In both studies, patients were randomized to receive either once daily MYL-1501D or Lantus. The primary endpoint was change from baseline in HbA1c after 24 weeks. Secondary endpoints included glycemic endpoints like change from baseline in fasting plasma glucose and insulin dose and safety endpoints like systemic reactions, device-related safety issues and immunogenicity.