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NovoLog (Insulin Aspart) Controls Post-Meal Blood Glucose Better than Regular Insulin in Women with Gestational Diabetes

PRINCETON, N.J. -- December 27, 2002 -- Insulin aspart (rDNA origin) injection (NovoLog®), a rapid-acting human insulin analog, provides better control of blood glucose following meals than regular insulin in women with gestational diabetes, according to new research published this month in Diabetes Care(1).

The findings are important because better control of post-meal blood glucose (postprandial glycemia) in gestational diabetes is associated with improved maternal and neonatal outcomes(1)(2) and with healthier birth weight(3).

"Because insulin aspart acts more rapidly than regular human insulin, we hypothesized it would provide better postprandial glycemic control-which is just what we found," said lead investigator David Pettitt, MD from the Sansum Medical Research Institute in Santa Barbara, California. "Given the link between postprandial glucose levels and pregnancy outcomes shown in other studies, these results suggest insulin aspart may improve outcomes for both mothers and infants," he said.

About Gestational Diabetes
Gestational diabetes mellitus (GDM), diabetes that is first recognized and diagnosed during pregnancy, occurs in about seven percent of pregnancies, though prevalence rates vary with ethnicity and maternal age. Pregnant women should be assessed for risk of GDM at their first prenatal visit, and retested between the 24^th and 28^th week of pregnancy(4).

GDM is associated with an increased risk for preeclampsia, Cesarean delivery, congenital abnormalities, perinatal mortality, maternal hypertension and diabetes, and obesity and diabetes in the offspring(4)(5). The most common neonatal complication of GDM is abnormally large body size (macrosomia), which occurs in as many as 40 percent of cases(6)(7). Neonatal macrosomia, in turn, is associated with increased risk of developing obesity in childhood and adulthood(8). GDM is treated through diet but may require insulin therapy to maintain adequate control of blood glucose levels(4). Oral hypoglycemic agents, used to treat type 2 diabetes, are generally not used to treat GDM because they can be toxic to the fetus(9).

Study and findings
The study included 15 women with GDM who had inadequate glycemic control by diet alone. On three consecutive days, participants consumed breakfast test meals, one with no insulin administered and the others after injection of either insulin aspart or regular human insulin (RHI). Researchers measured levels of plasma insulin, glucose and C-peptide concentrations for four hours after breakfast. C-peptide is a small protein released along with insulin by the pancreas.

Insulin aspart was more effective than RHI in blunting the postprandial glucose peak 60 minutes after the meal (112, 116 and 123 mg/dL for insulin aspart, RHI and no insulin, respectively; p<0.01 and p<0.05 for insulin aspart and RHI, respectively, vs. no insulin). The overall increase in the amount of glucose in the bloodstream following the meal was significantly lower with insulin aspart, but not with RHI, compared to no insulin (7.1, 30.2 and 29.4 mg*hr/dL for the 3-hour area under the curve for insulin aspart, RHI and no insulin, respectively; p=0.018 and 0.997 for insulin aspart and RHI, respectively, vs. no insulin). The peak insulin concentration was higher and the peak C-peptide concentration was lower with both types of insulin compared to no insulin.

Dr. Pettitt noted that regular human insulin is the current standard therapy for gestational diabetes when diet therapy fails to adequately control blood glucose concentrations, and insulin analogs are not currently recommended(4). "But that may change," he said, "if additional studies verify our findings and ensure the safety of insulin aspart in women with gestational diabetes."

The study was supported in part by Novo Nordisk Pharmaceuticals, Inc.

About NovoLog
NovoLog is indicated for the control of hyperglycemia in adult patients with diabetes mellitus. Because it has a more rapid onset and shorter duration of action than regular human insulin, it is recommended to use NovoLog in combination with an intermediate or long-acting insulin, and to eat immediately after injection. 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(10). NovoLog is the first and only insulin analog approved for pump use and is the first of several insulin analogs in development from Novo Nordisk. Other products in development include premixed and long-acting insulin analogs. NovoLog is available 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; and NovoPen® 3 and NovoPen Junior. NovoLog is also available in 10 mL vials.

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. For individual countries, the direct health care costs of diabetes are from 2.5% to 15% of annual national health care budgets, depending on the prevalence of diabetes in the country and the sophistication of the treatment available(11).

Full prescribing information for NovoLog® is available by contacting Novo Nordisk Pharmaceuticals, Inc.

NovoLog, Innovo and NovoPen are registered trademarks of Novo Nordisk A/S.

InDuo is a trademark of Novo Nordisk A/S and Johnson & Johnson. Novo Nordisk is a focused healthcare company and the world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.

With headquarters in Denmark, Novo Nordisk employs approximately 17,900 people in 68 countries and markets its products in 179 countries. For global company information visit <http://www.novonordisk.com> . For United States information, visit <http://www.novonordisk-us.com> .

References:
(1) Pettitt DJ, Kolaczynski JW, Ospina P, Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care 2003;26(1):183-186.
(2) Langer O, Mazze R. The relationship between large-for-gestational-age infants and glycemic control in women with gestational diabetes. Am J Obstet Gynecol 1988;159(6):1478-83.
(3) Jovanovic-Peterson L, Peterson CM, Reed GF, Metzger BE, Mills JL, Knopp RH, Aarons JH. Maternal postprandial glucose levels and infant birth weight: the Diabetes in Early Pregnancy Study. The National Institute of Child Health and Human Development-Diabetes in Early Pregnancy Study. Am J Obstet Gynecol 1991; 164(1 Pt 1):103-111.
(4) American Diabetes Association. Gestational diabetes mellitus: position statement. Diabetes Care 2002 Jan; 25(suppl):S94-S96.
(5) Persson B, Hanson U. Neonatal morbidities in gestational diabetes mellitus. Diabetes Care 1998 Aug;21 Suppl 2:B79-B84.
(6) Jovanovic L, Pettitt DJ. Gestational diabetes mellitus. JAMA 2001;286(20):2516-2518.
(7) de Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, Evans AT. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med 1995; 333(19):1237-1241.
(8) Hediger ML, Overpeck MD, McGlynn A, Kuczmarski RJ, Maurer KR, Davis WW. Growth and fatness at three to six years of age of children born small- or large-for-gestational age. Pediatrics 1999;104(3):1-6.
(9) The Merck Manual of Medical Information-Home Edition. Section 22, Women's Health Issues, Chapter 246. Diabetes. <http://www.merck.com/pubs/mmanual_home/sec22/246.htm>.
(10)Novo Nordisk Pharmaceuticals, Inc. NovoLog® (insulin aspart [rDNA origin] injection). Package insert. Novo Nordisk Pharmaceuticals, Princeton New Jersey. March 2001.
(11)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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