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PARIS – Sanofi (EURONEXT: SAN and NYSE: SNY) said Monday that the first phase 3 study results (EDITION I) for its investigational new insulin U300 showed equivalent blood sugar control with fewer night-time low blood sugar events compared to Lantus?(insulin glargine [rDNA origin] injection). The company also announced topline results of a second Phase 3 study (EDITION II) for investigational new insulin U300 that also demonstrated similar blood sugar reduction while fewer patients experienced night-time low blood sugar events compared with Lantus.
These results are from EDITION I and EDITION II respectively and are part of the EDITION Phase 3 clinical program evaluating the efficacy and safety of the investigational new insulin U300 in people with diabetes. The EDITION I data was presented at the 73rd Scientific Sessions of the American Diabetes Association.
“To properly manage diabetes, it is critical to control blood sugar and to reduce the risk of low blood sugar events, especially at night,’ said Matthew Riddle, professor of Medicine, Division of Endocrinology/Diabetes/Clinical Nutrition, Oregon Health and Science University, and principal investigator for the EDITION I study. “I am encouraged by these findings, and look forward to the results of the full Phase 3 EDITION program, which will further reveal how this investigational basal insulin may help people living with diabetes.”
As the first study of the EDITION Phase 3 program, EDITION I evaluated the efficacy and safety of investigational new insulin U300 vs. Lantus in people with type 2 diabetes using basal plus mealtime insulin. In a multicenter, open-label study 807 people were randomized (1:1) to once daily evening new insulin U300 (n=404) or Lantus? (n=403) while continuing mealtime insulin. The basal insulin was titrated to achieve fasting plasma glucose of 80-100 mg/dL. Primary endpoint was change in HbA 1c from baseline to month 6, and main secondary endpoint was % of people with at least 1 severe or confirmed (≤70 mg/dL) nocturnal hypoglycemic event from month 3 to month 6.
The EDITION I abstract is titled: New Insulin Glargine Formulation: Glucose Control and Hypoglycemia in People with Type 2 Diabetes Using Basal and Mealtime Insulin (EDITION I) (Riddle, MC et al) [Abstract no. 43-LB]
EDITION II evaluated efficacy and safety of new insulin U300 in a type 2 diabetes population (811 patients) treated with basal insulin plus oral antidiabetic therapy. The full EDITION II results will be submitted for presentation at upcoming scientific meetings.
“There remains a substantial unmet need in people with diabetes taking oral medication or insulin as many of them do not reach their glycemic goals,” said Pierre Chancel, senior vice president, Global Diabetes, Sanofi. “With the investigational new insulin U300, we are striving to further enhance the clinical value of basal insulin, while building on the wealth of evidence of Lantus, the world's most prescribed insulin.”
Investigational new insulin U300 is a new formulation based on the glargine molecule, the biological entity of Lantus, with its well established efficacy and safety profile. However, new insulin U300 has unique pharmacokinetic and pharmacodynamic profiles with studies demonstrating it has even flatter and more prolonged profiles than Lantus . [1],[2] New insulin U300 also offers the benefit of a smaller volume of subcutaneous injection compared with Lantus
1 Tillner J et al. Euglycemic ClOff White X Max 98