Novo Nordisk, a worldwide leader in diabetes care, announced that enrolment has begun for INITIATE plus (Initiation of Insulin to reach A1C Target Phase 4 Open-Label Use Study) to explore if insulin therapy with NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) and nutritional counselling can help glycemic control while reducing the risk of minor hypoglycemic events. Enrolment is expected to be completed by April 2005 and is limited to the first 2000 physicians.
"Many people with type 2 diabetes resist starting insulin therapy, even when it is clearly needed to manage their diabetes and potentially reduce the risk of long-term complications," said Peter Aurup, vice president of drug development of Novo Nordisk Pharmaceuticals, Inc.
INITIATE plus will compare the benefits of conventional dietary intervention (one counselling session with a dietitian) and an intensive dietary intervention (three counselling sessions with a dietician) against no intervention in reducing the rate of minor hypoglycemic events in type 2 diabetes patients starting insulin therapy.
Patients in the study will be treated with a standard titration of NovoLog Mix 70/30, a dual-action insulin analog designed to control both postprandial blood glucose (PPG) and fasting blood glucose (FPG) levels. The treatment will be provided in the NovoLog Mix 70/30 FlexPen, a prefilled, disposable insulin delivery device. Patients also will receive educational materials about adjusting to insulin, the importance of exercise, and the value of healthy eating habits.
"Given the growing awareness of the importance of controlling PPG in addition to FPG in achieving target A1C levels, it is critical patients understand the value of starting insulin therapy as well as the treatment and delivery device options available to them," said Aurup. "As a premix insulin analog that manages both PPG and FPG levels, NovoLog Mix 70/30 may be a treatment option for people starting insulin therapy."
NovoLog Mix 70/30 is indicated for the treatment of patients with diabetes mellitus for the control of hyperglycemia.