NovoLog insulin analog now available in disposable prefilled pen
PRINCETON, N.J., March 3, 2003 -- Novo Nordisk announced that NovoLog (insulin aspart, (rDNA origin) injection), the company's rapid-acting insulin analog, is now available nationwide in the new FlexPen prefilled syringe for the treatment of diabetes.
"We are pleased to make NovoLog available in FlexPen, our most advanced insulin pen device, as another treatment option for people with diabetes," said Martin Soeters, president of Novo Nordisk Pharmaceuticals, Inc. "The convenient mealtime dosing of NovoLog, combined with the accuracy and flexibility of FlexPen, can help people with diabetes more easily achieve glycemic control," he said.
NovoLog has faster absorption, a faster onset, and shorter duration of action than regular human insulin, making it well suited for mealtime bolus dosing to control postprandial glycemia, the rise in blood sugar following food consumption. Regular human insulin acts more slowly so patients usually must administer it 30 minutes before eating.
Soeters said that a number of features make NovoLog FlexPen easy to learn, easy to use, and easy to train patients to use. Once in use, the 3 mL prefilled pen can be used for 28 days without refrigeration -- an advantage for many patients. The pen's large, clear scale allows for simple, single-step dose settings that can be accurately made and adjusted.
The mechanism does not allow a dose larger than that remaining in the pen, permits dose corrections without loss of insulin, and provides doses in one-unit increments up to 60 units per injection (each pen contains 300 units total). The dose scale automatically returns to zero after injection to allow visual confirmation of dose delivery. Finally, he said that many patients find the short, ultra-thin NovoFine disposable needles used with FlexPen help make injections more comfortable.
A dual-acting formulation of insulin aspart, NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, (rDNA origin)), was also made available with FlexPen (NovoLog Mix 70/30 FlexPen) in September of 2002. A study (1) in people with type 2 diabetes showed a marked preference for NovoLog Mix 70/30 FlexPen over the lispro mix pen (75% insulin lispro protamine suspension and 25% insulin lispro injection (rDNA origin)), another premixed insulin and prefilled pen.
While the researchers found the two devices comparable in terms of safety and efficacy, participants reported preference for the NovoLog Mix 70/30 FlexPen, in terms of overall ease of use, by more than an 8-to-1 margin (73.6% preferred the NovoLog Mix 70/30 FlexPen, compared to 9.1% who preferred the lispro mix pen). The researchers also found that 75% of the participants said they wanted to continue using the NovoLog Mix 70/30 FlexPen when the trial ended. The multinational, multicenter, open labeled, randomized two-period crossover study included 137 people with type 2 diabetes. (1)
NovoLog is indicated for the treatment of adult patients with diabetes mellitus, for the control of hyperglycemia. Because it has a more rapid onset and shorter duration of action than regular human insulin, NovoLog should normally be used in regimens together with an intermediate or long-acting insulin, and injection of NovoLog should immediately be followed by a meal. NovoLog is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog or one of its excipients. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog. See package insert for more details. (2)
NovoLog is available in PenFill 3 mL cartridges for administration in InDuo, the world's first combined blood glucose monitoring and insulin dosing system; Innovo, the world's first insulin doser with built-in memory; NovoPen 3, one of the most popular insulin delivery devices in the world; and NovoPen Junior, an insulin delivery system that features half-unit dosing increments. NovoLog is the first and only insulin analog approved for pump use and is the first of several insulin analogs developed by Novo Nordisk. Other products in development include long-acting insulin analogs.
Full prescribing information for NovoLog and NovoLog Mix 70/30 is available by contacting Novo Nordisk Pharmaceuticals, Inc.
(1) Vora JP, Nygaard-Pedersen L, Erichsen K, Hansen AB, Niskanen L. Patients with type 2 diabetes using biphasic insulin analog prefer NovoMix 30 FlexPen to the HumaLog Mix 25 Pen. Abstract 546-P (Poster presentation at: American Diabetes Association annual meeting, San Francisco, CA, June 14-18, 2002) Diabetes 2002; 51 (suppl 2): A135.
(2) Novo Nordisk Pharmaceuticals, Inc. NovoLog (insulin aspart [rDNA origin] injection). Package insert. Novo Nordisk Pharmaceuticals, Princeton New Jersey. March 2001.
Source: Novo Nordisk www.novonordisk-us.com
Posted: March 2003