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Rapid-Acting Insulin Analog Insulin Aspart Equally Effective, Safe in Pump Therapy or Multiple Daily Injections For Treatment of Type 2 Diabetes

Nine out of ten patients in study prefer pump therapy over previous injected insulin regimen for convenience, flexibility, ease of use.

PRINCETON, NJ -- August 26, 2003 -- The rapid-acting human insulin analog insulin aspart (rDNA origin injection; brand name, NovoLog®) is as effective and safe in controlling blood glucose in people with type 2 diabetes when administered by continuous subcutaneous infusion (CSII or "pump therapy") or multiple daily injections, according to new research published in the September issue of Diabetes Care.(1) Among the study participants, more than nine out of ten preferred CSII therapy to their previous injected insulin regimen because of the greater convenience, flexibility and ease of use of CSII.

The study is the first on the use of any insulin analog in CSII therapy in people with type 2 diabetes. Currently, only NovoLog and Velosulin® BR Buffered Regular, Human Insulin Injection (rDNA origin) are approved by the U.S. Food and Drug Administration for use in CSII therapy.

"Our study showed that, in treating type 2 diabetes, insulin aspart was highly effective and compatible with pump therapy, and improved some measures of blood glucose control over multiple daily injection therapy," said lead author said Philip Raskin, M.D., Professor of Medicine at the University of Texas Southwestern Medical Center in Dallas, Texas. He added that, because the study also showed patients can be trained to use pumps on an outpatient basis and greatly prefer it to multiple injection therapy, "CSII therapy may indeed be the preferred method of intensive insulin therapy."

CSII therapy uses a small external pump to infuse insulin continuously throughout the day, and can be programmed to release extra insulin (bolus) before meals, according to the patient's needs. In this way, it is similar to the action of the human pancreas.

Study and findings

The multicenter, open-label study included 132 people with type 2 diabetes who were previously being treated with at least one insulin dose per day with or without an oral anti-diabetic agent but had never before received CSII therapy. They were randomly assigned to receive CSII or multiple daily injection (MDI) therapy for 24 weeks; oral anti-diabetic therapy was discontinued at the start of the study. MDI therapy consisted of mealtime injections of NovoLog and injections of the long-acting insulin Novolin N (NPH, Human Insulin Isophane Suspension [rDNA origin]) once or twice daily. All participants recorded self-monitored blood glucose (SMBG) readings at eight time points during the day as well as insulin doses and any symptoms of hypoglycemia. Participants also completed a questionnaire at the beginning of the study about their satisfaction with their previous insulin regimen, and at weeks 16 and 24 about satisfaction with their therapy during the study.

At the end of the study, both groups showed significant improvements in A1C values from baseline (CSII from 8.2 to 7.6 percent; MDI from 8.0 to 7.5 percent) and daily blood glucose profiles. Blood glucose was consistently lower for the CSII group 90 minutes after breakfast (9.2 + 2.6 mmol/L [167 + 48 mg/dL] vs. 10.7 + 3.6 mmol/L [192 + 65.0 mg/dL], P = 0.019).

Insulin aspart was found to be highly compatible with CSII therapy, based on the relatively infrequent incidence of clogs or blockages of the pump or infusion sets: 82 percent of participants reported only one or less clog or blockage per week and nearly all responded appropriately, evidenced by only one event during the entire study coinciding with a hyperglycemic episode. The rates of hypoglycemia and adverse events were similar for the two groups. The CSII and MDI groups, respectively, reported 0.8 and 1.2 hypoglycemic episodes per participant per 30 days, and adverse events were reported by 77 and 70 percent of participants.

Among participants who received CSII therapy, 93 percent preferred it to their previous injected insulin regimen because of convenience, flexibility, ease of use and overall preference. Additionally, the CSII group showed significantly greater improvement in overall treatment satisfaction than the MDI group, from 59.4 + 2.1 at baseline to 79.2 + 1.8 at the end of the study vs. 63.6 + 1.9 to 70.3 + 2.3, respectively, (P < 0.001 for comparison of the improvement for the two groups). Possible scores ranged from 0 to 100 for least to most satisfaction, respectively. Similarly greater improvements for the CSII group were found for the various subscales of satisfaction, including less social limitations, preference, advocacy, less hassle, less life interference, general satisfaction, flexibility, convenience, less burden and less pain (all differences were significant except for less pain).

"Many people with type 2 diabetes resist going on to insulin therapy and/or poorly comply with it, which can result in less-than-optimal control," said Dr. Raskin. "Therefore, increasing patient satisfaction with insulin therapy -- as we found with insulin aspart pump therapy -- can be both psychologically and clinically very important."

About NovoLog

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 NovoLog FlexPen®, the prefilled pen that's easy to learn, easy to use and easy to train patients to use. NovoLog is also available in PenFill® 3 mL cartridges for administration; 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.

About diabetes

The prevalence of diabetes is skyrocketing in many countries around the world. According to the World Health Organization (WHO), the number of people worldwide with the condition was estimated at 30 million in 1985, 135 million in 1995, and 177 million in 2000, and is expected to increase to at least 300 million by 2025.(3) For individual countries, the direct health care costs of diabetes are from 2.5 percent to 15 percent of annual national health care budgets, depending on the prevalence of diabetes in the country and the sophistication of the treatment available.(3)

Full prescribing information for NovoLog is available by contacting the manufacturer.

NovoLog, Velosulin, Novolin N, FlexPen, PenFill, Innovo, and NovoPen are registered trademarks of Novo Nordisk A/S.

InDuo is a registered trademark of Johnson & Johnson and Novo Nordisk A/S.

References:

1 Raskin P, Bode BW, Marks JB, Hirsch IB, Weinstein RL, McGill JB, Peterson GE, Mudaliar SR, Reinhardt RR. Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes. Diabetes Care 2003; 26(9): 2598-2603.

2 Novo Nordisk Pharmaceuticals, Inc. NovoLog® (insulin aspart [rDNA origin] injection). Package insert. Novo Nordisk Pharmaceuticals, Princeton New Jersey. March 2001.

3 The World Health Organization. The Cost of Diabetes. Fact Sheet number 236, revised September 2002. http://www.who.int/mediacentre/factsheets/fs236/en/.


SOURCE: Novo Nordisk

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