Date: 2017-06-10
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Diabetes Association's 77th Scientific Sessions in San Diego
Company: Mylan (USA - PA) Biocon (India)
Product: MYL-1501D (biosimilar version of insulin glargin)
Action
mechanism: biosimilar/insulin analog
Disease: type 1 diabetes, type 2 diabetes
Therapeutic
area: Metabolic diseases
Country: Canada, Czech Republic, Estonia, Germany, Hungary, Latvia, Romania, Slovakia, South Africa, UK, USA (INSTRIDE1), Jordan, Republic of Korea ,Slovakia, South Africa, Taiwan, USA (INSTRIDE2)
Trial
details:
- 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 (including insulin-naïve) patients. In both studies, patients were randomized to receive either once daily MYL-1501D or Lantus® and 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, as well as safety endpoints like systemic reactions, device-related safety issues and immunogenicity.
Latest
news:
- • On June 10, 2017, Mylan and Biocon 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.
- Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Proposed Biosimilar Insulin Glargine and Lantus in Patients with Type 1 diabetes (T1D) (Poster #1019-P)
- Efficacy and safety of MYL-1501D (Mylan's insulin glargine) compared with Lantus® (Sanofi's insulin glargine) in patients with Type 1 diabetes after 52 weeks: The INSTRIDE 1 study (Poster #1018-P)
- Efficacy and safety of MYL-1501D (Mylan's insulin glargine) compared with Lantus® (Sanofi's insulin glargine) in patients with Type 2 diabetes after 24 weeks: The INSTRIDE 2 study (Poster #1017-P)
- Comparable Immunogenicity between MYL-1501D (Mylan's insulin glargine) and Lantus® (Sanofi's insulin glargine) in Patients with Type 1 and 2 Diabetes Mellitus: The Phase 3 INSTRIDE studies (Poster #1028-P)
Is
general: Yes
