Princeton, NJ (July 12, 2005) – Novo Nordisk today announced its GlucaGen® HypoKit™ (glucagon [rDNA origin] for injection), is now available for use to treat severe hypoglycemic reactions that may occur in individuals who have insulin-dependent diabetes. The GlucaGen HypoKit is fully portable and can be used wherever it is needed, in any setting.
GlucaGen HypoKit is an emergency kit consisting of a syringe prefilled with sterile water for mixing and a vial of GlucaGen powder. The hard-shell, bright orange case provides product protection, does not require refrigeration, and is easily identifiable in an emergency. GlucaGen HypoKit also has comprehensive picture instructions for the administrator during an emergency situation and holds no danger of overdose. Family members or caregivers should practice and become familiar with the technique of preparing glucagon before an emergency arises. Additionally, GlucaGen HypoKit is safe for use in children.
"Making GlucaGen available to people living with diabetes in a non-hospital setting addresses a huge unmet medical need because a vast majority of patients on insulin therapy do not currently own a glucagon emergency kit," said Peter Aurup, M.D., vice president of Clinical Development, Medical, and Regulatory Affairs, Novo Nordisk Inc. "GlucaGen HypoKit is an important and potentially life-saving addition to our U.S. portfolio, demonstrating our commitment to leadership in diabetes care," he added.
Hypoglycemia, also called low blood sugar, occurs when the body's insulin level is too high and blood glucose (sugar) level drops too low to provide enough energy for the body's normal functions.1, 2 If mild or moderate hypoglycemia is not treated promptly with some form of glucose, it can develop into severe hypoglycemia.3
Sixty-five percent of people living with type 1 diabetes4, 5 intensively treated with insulin over 6.5 years experienced severe hypoglycemia, this risk being three times higher with intensive insulin therapy vs. conventional insulin therapy. Eleven percent of people living with type 2 diabetes6 treated with insulin had major glycemic episodes requiring third-party assistance or hospital admission over six years.
"The fear of hypoglycemia is a major barrier to patients achieving optimal blood glucose control, particularly in patients who have had severe hypoglycemia including a convulsive or unconscious episode," commented Francine R. Kaufman, M.D., author of Diabesity (Bantam). "GlucaGen HypoKit will provide people living with diabetes an immediate first choice solution to severe hypoglycemia."
GlucaGen is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes treated with insulin. GlucaGen should be used with caution in patients with conditions such as prolonged fasting, starvation, adrenal insufficiency, or chronic hypoglycemia because these conditions result in low levels of releasable glucose in the liver and an inadequate reversal of hypoglycemia by GlucaGen treatment. Nausea and vomiting may occur especially with doses above 1 mg. Allergic reactions may occur and include generalized rash. Do not use GlucaGen if you are allergic to glucagon or to one of the inactive ingredients in GlucaGen. Hypoglycemia may occur again following glucagon treatment.7
GlucaGen is the Novo Nordisk brand name for recombinant biosynthetic glucagon. Novo Nordisk's GlucaGen (glucagon) was approved June 22, 1998 as a diagnostic aid during radiological examinations and for treating severe hypoglycemia in patients with diabetes treated with insulin. GlucaGen HypoKit includes a vial containing 1 mg of freeze-dried glucagon (rDNA) with a disposable prefilled syringe containing 1 ml Sterile Water for Reconstitution (SWFR).
In the treatment of severe hypoglycemia in people living with insulin-dependent diabetes, GlucaGen raises blood glucose by promoting the release of glucose from glycogen stores in the liver. Blood sugar levels increase within 10 minutes and peak at 30 minutes post peak at 30 minutes post injection.
For more information regarding GlucaGen HypoKit, please contact Novo Nordisk Inc. at 1-800-727-6500 or visit www.novonordisk-us.com.
About hypoglycemia and diabetes
Severe hypoglycemia occurs when blood glucose level decreases to a point and remains at that level too long, where the brain becomes deprived of sufficient energy to function properly.2, 8 This level of hypoglycemia results in a loss of consciousness and/or seizure, coma or death.2
The causes of hypoglycemia in people with diabetes1 taking certain blood-glucose lowering medications include inadequate, delayed, or skipped meals or snacks; excessive doses of insulin or some diabetes medications; increased activity or exercise; and excessive alcohol consumption.
Left untreated, severe hypoglycemia can cause prolonged loss of consciousness, a life-threatening condition.
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GlucaGen® is a registered trademark of Novo Nordisk A/S.
HypoKit™ is a trademark of Novo Nordisk A/S.
Novo Nordisk is a healthcare company with an 80-year history of innovation and achievement in diabetes care. With the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems, Novo Nordisk is a world leader in diabetes care. In the United States, Novo Nordisk's ambition is to change the course of diabetes for good. Working as a catalyst to improve diabetes prevention and treatment, the company strives to be the preferred partner for employees, patients, healthcare providers, and others in the healthcare system who share its vision to defeat diabetes. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs approximately 21,000 full-time employees in 78 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit www.novonordisk.com; for United States information, visit www.novonordisk-us.com.
For further information please contact:
Mads Veggerby Lausten
1 National Diabetes Information Clearinghouse (NDIC). Hypoglycemia.
http://diabetes.niddk.nih.gov/dm/pubs/hypoglycemia/. Accessed June 21, 2005.
2 Mayo Clinic. Hypoglycemia and diabetes: What to watch out for.
http://www.mayoclinic.com/invoke.cfm?objectid=EA9AC880-CF40-4B85-B17EC482744767F4&locID=. Accessed June 21, 2005.
3 American Diabetes Association. Preventing & treating Severe Hypoglycemia.
http://www.diabetes.org/preventing.jsp. Accessed June 21, 2005.
4 The Diabetes Control and Complications Trial Research Group. Hypoglycemia in the Diabetes Control and Complications Trial. Diabetes. 1997;46:271-286.
5 The DCCT Research Group. Epidemiology of severe hypoglycemia in the diabetes control and complications trial. Am J Med. 1991;90:450-459. (FROM Novo Nordisk HCP Brochure)
6 UK Prospective Diabetes Study Group. UK (FROM Novo Nordisk HCP Brochure) prospective diabetes study16. Overview of 6 years' therapy of type 2 diabetes: A progressive disease. Diabetes. 1995;44:1249-1258. (ALSO FROM Novo Nordisk HCP Brochure)
7 Novo Nordisk Inc., GlucaGen® HypoKit Physician Brochure
8 Aetna InteliHealth. Health A To Z: Hypoglycemia.
http://www.intelihealth.com/IH/ihtIH/WSIHW000/9339/10169.html. Accessed June 21, 2005.