FDA Approves 2 New Options for Diabetes
Tresiba, a long—acting insulin analog, is indicated for the improvement of glycemic control in patients with both type 1 and type 2 diabetes mellitus, and is administered via a once-daily injection.
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The safety and efficacy of Tresiba in patients with type 1 diabetes was evaluated in 2 26-week and 1 52-week active-controlled clinical trials involving a total of 1102 participants. Its treatment of patients with type 2 diabetes was evaluated in 4 26-week and 2 52-week active-controlled trials involving a total of 2702 participants.
In both patients with type 1 and 2 diabetes with inadequate blood sugar control at the beginning of the trials, Tresiba reduced HbA1c as well as other, previously approved long-acting insulin products.
Ryzodeg 70/30 for patients with type 1 diabetes was evaluated in 1 26-week active-controlled trial of 362 participants, and in 4 active-controlled 26-week clinical trials involving 998 participants for patients with type 2 diabetes.
Overall, Ryzodeg 70/30 reduced HbA1c levels as well as previously approved long-acting insulin products.
Both medications should not be used in patients with diabetic ketoacidosis. The most common side effects were hypoglycemia, allergic reactions, lipodystrophy, rash, edema, and weight gain.
FDA. FDA approves two new drug treatments for diabetes mellitus [press release]. September 25, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm464321.htm.