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]
Topline results of EDITION II are consistent with EDITION I findings. EDITION II demonstrated that investigational new insulin U300 achieved similar blood sugar reduction while fewer patients experienced night-time low blood sugar events compared with Lantus®.
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."
About investigational new insulin U300
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®.
About the EDITION Phase 3 Program
The EDITION program is a worldwide and comprehensive series of Phase 3 studies evaluating the efficacy and safety of new insulin U300 in broader and diverse populations of people with diabetes. The full EDITION I (basal + mealtime insulin) and EDITION II (basal Insulin + oral therapy) results are expected by the end of this year. Additionally, the following Phase 3 studies from the EDITION program are ongoing: EDITION III in insulin-naïve type 2 diabetes patients, EDITION IV in type 1 diabetes patients, EDITION JP I in Japanese type 1 diabetes patients (basal + bolus insulin) and EDITION JP II in Japanese type 2 diabetes patients (basal insulin + oral therapy).
About Lantus (insulin glargine [rDNA origin] injection)
Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and children (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.
Do not use Lantus to treat diabetic ketoacidosis.
Important Safety Information for Lantus
Do not take Lantus if you are allergic to insulin or any of the inactive ingredients in Lantus.
You must test your blood sugar levels while using insulin, such as Lantus. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix Lantus with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus must only be used if the solution is clear and colorless with no particles visible. Do not share needles, insulin pens or syringes with others.
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