Novo Nordisk marks 10th year of pre-mixed insulin, pen system

MANILA, Philippines - In 2003, diabetes care pioneer Novo Nordisk launched an accurate and easy-to-use dual-release insulin analogue and pen system designed specifically for people with diabetes starting insulin therapy.

Today, millions of patients have been treated with Biphasic Insulin Aspart 30, equivalent to a total of 10.7 million patient-years.

Since its launch, Biphasic Insulin Aspart 30 has received regulatory approval for use in the elderly, use with oral anti-diabetes drugs (OADs), use in children aged 10 and older, patients shifting from pre-mixed human insulin to pre-mixed analogue insulin, and intensification to three times a day injection.

Biphasic Insulin Aspart 30 is a unique insulin analogue that combines 30 percent ultra rapid-acting insulin aspart and 70 percent intermediate-acting protaminated insulin aspart. It is administered through a patented three-milliliter pre-filled glass cartridge contained in a dial-a-dose insulin FlexPen.

“The dual-release action of Biphasic Insulin Aspart 30 provides patients with three important benefits. First, it mimics physiological insulin release, with the early release of rapid-acting insulin targeting postprandial (after-meal) blood sugar while the sustained release of intermediate-acting insulin fulfills the body’s basal insulin requirement. Second, it has a lower hypoglycemia risk than conventional pre-mixed analogue insulins. Third, its simplified twice-daily dosing provides both satisfactory blood sugar control and convenience,” said Dr. Augusto Litonjua, professor emeritus of the University of the Philippines College of Medicine.

Litonjua, the “father” of Philippine endocrinology, was the guest speaker during the dinner symposium entitled “Biphasic Insulin Aspart 30: Celebrating a 10-year journey toward intensification” organized by Novo Nordisk Pharmaceutical (Phils.) last Oct. 21 at the Sofitel Philippine Plaza Hotel. Around 300 local endocrinologists, diabetes specialists, cardiologists and internists attended the event.

“Biphasic Insulin Aspart 30 targets both fasting and postprandial blood sugar at the same time,” Litonjua said. “This is very important because postprandial hyperglycemia (blood sugar elevation) has a stronger association with cardiovascular mortality than FPG (fasting plasma glucose). In fact, postprandial glucose elevation after lunch predicts cardiovascular risk better than any other glycemic parameters in type 2 diabetes. Moreover, both fasting and mealtime glucose contribute to the overall daily glycemic load at all HbA1c levels.”

Litonjua cited results of various randomized clinical trials (INITIATE, EuroMix, ACTION, OnceMix), which showed that Biphasic Insulin Aspart 30 improves HbA1c, FPG, postprandial glucose (PPG) and rates of hypoglycemia, with simple intensification of the dose.

He also highlighted real-world data from observational studies and clinical experience evaluation studies. Involving a total of more than 100,000 patients on a wide variety of diabetes treatment regimens, the 1-2-3 Study, PRESENT, IMPROVE and A1chieve showed that Biphasic Insulin Aspart 30 produced significant reductions in HbA1c, FPG and PPG with minimal hypoglycemic events and negligible weight gain.

Litonjua concluded his talk by citing ongoing studies on Biphasic Insulin Aspart 30. These include the SimpleMix Trial (investigator-driven vs patient-driven titration of Biphasic Insulin Aspart 30), Sit2Mix Study (addition of Biphasic Insulin Aspart 30 to sitagliptin or substitution with Biphasic Insulin Aspart 30), and EasyMix Extension Study (efficacy of two different dosages of twice-dailyBiphasic Insulin Aspart 30).

“We thank our partner doctors for helping Novo Nordisk change the lives of Filipino patients with diabetes through Biphasic Insulin Aspart 30. Novo Nordisk will continue to discover and develop innovative therapies for diabetes patients around the word,” said Christine Rosal, country manager of Novo Nordisk Pharmaceuticals (Phils.).