CHICAGO, June 25, 2007 /PRNewswire-FirstCall/ -- Novo Nordisk today announced results of a new study that further demonstrated the safety and efficacy of insulin Levemir(R) (insulin detemir [rDNA origin] injection). Patients with type 2 diabetes were able to adjust their own dosage of Levemir(R) and achieve improvements in blood sugar, comparable to dosing adjusted by their primary care physician. This improvement in A1c levels was observed with minimal weight change and without increases in rates of hypoglycemia.(1) The data were presented at the 67th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois.
"The study is a testament to the safety of Levemir(R), as patients were able to adjust their basal insulin dose on their own and achieve the same level of glycemic control as when guided by their doctor, while reducing the risk of hypoglycemia," said Luigi Meneghini, MD, MBA, Associate Professor of Clinical Medicine and the Director of the Eleanor and Joseph Kosow Diabetes Treatment Center at the Diabetes Research Institute, Miami, FL. "Since having type 2 diabetes requires a great deal of self-management, these findings will help empower patients to work more closely as partners with their physician to take control of their insulin treatment. The potential of improved self- management is made possible by insulin analogs like Levemir(R), which provide effective basal insulin coverage, and, as shown in this study, the added benefit of minimal weight change."
The new data were obtained from the insulin detemir 303 Algorithm tested in a Randomized Clinical Trial: The US PREDICTIVE(TM) 303 Trial (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation), which included 5,604 patients. The data showed that patient sel f-adjustment of insulin treatment with Levemir(R) was as safe and effective when compared to dosing that was adjusted by physicians according to standard-of-care. The patients who self- adjusted their dosage achieved a level of diabetes control that was comparable to that of patients receiving physician-driven adjustments. Minimal weight change was observed in both trial arms.(2)
The findings on weight gain are consistent with previous studies of Levemir(R), the first insulin to show less weight gain versus other basal insulins in 12 of 12 controlled clinical trials*.(3) Weight gain is a common side effect of insulin therapy, which is a concern given that 80 percent of people with type 2 diabetes are overweight or obese.
About the Study (Abstract #197-OR):
The new data presented at ADA were from a six-month analysis of 5,604 type 2 diabetes patients, in a mainly primary care settings, and predominantly treated with Levemir(R) once-daily, as an add-on therapy to any other glucose- lowering regimens, or as replacement of a previous basal insulin. Patients were randomized to either the "303 Algorithm" [self adjusting their Levemir(R) dose every three days based on fasting plasma glucose (FPG)] or "Standard-of- Care" (Levemir(R) dose was physician-adjusted according to standard-of-care) treatment groups.
The study showed that the average A1c, an indicator of long-term blood glucose control, decreased from 8.5 percent at baseline to 7.9 percent at 26 weeks for the 303 Algorithm group, and from 8.5 percent to 8.0 for Standard- of-Care group (p=0.001). Compared to baseline, FPG values decreased by 34 and 21 mg/dL for 303 Algorithm and Standard-of-Care groups, respectively (p<0.0001).
At 26 weeks, 88 percent of all patients remained on once-daily Levemir(R) therapy. In a subset of insulin-naÃ¯ve patients who added Levemir(R) to their standard-of-care therapy, well over 90 percent of patients remained on a once- daily dosing thr oughout the 6-month trial. Both groups had a significant improvement in glycemic control, with no increases in hypoglycemia (major hypoglycemic events were .02 event/patient/month for both groups) and minimal weight change (.2 kg for 303 Algorithm group and -.3 kg for Standard-of-Care group).
Levemir(R) (insulin detemir [rDNA origin] injection) is a long-acting insulin analog indicated for once- or twice-daily subcutaneous administration for the treatment of adults and children with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. Levemir(R) has a relatively flat action profile with up to 24 hours duration of action. It can be added to oral anti-diabetic agents, or used in combination with a rapid-acting insulin. Levemir(R) is available in FlexPen(R), a prefilled disposable insulin pen for easy, discreet dosing and in vials.
Levemir(R) was approved by the U.S. Food and Drug Administration in June 2005 and was launched in the U.S. in March 2006. Levemir(R) has been available for use in Europe since March 2004 and is currently approved in 50 countries worldwide. Levemir(R) is contraindicated in patients hypersensitive to insulin detemir or its excipients. Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir(R). As with all insulins, the timing of hypoglycemic events may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. Other adverse events commonly associated with insulin therapy may include injection site reactions (on average 3-4 percent of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, and inflammation.
Any change of insulin dose should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may require adjustment. Levemir(R) should not be dilut ed or mixed with any other insulin preparations or used in insulin infusion pumps. Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia in patients being switched to Levemir(R) from other intermediate or long-acting insulin preparations. The dose of Levemir(R) may need to be adjusted in patients with renal or hepatic impairment.
*Whether the observed differences in weight represent true differences in the effects of Levemir(R) and other therapies is not known, since these trials were not blinded and the protocols (e.g., diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects. The clinical significance of the observed differences has not been established.
Prescribing information for Levemir(R) is available by contacting Novo Nordisk or visiting novonordisk-us.com.
Levemir(R) and FlexPen(R) are registered trademarks of Novo Nordisk A/S.
Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis 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 more than 23,600 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges i n Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.
(1) Meneghini L, Koehnen C, Weng W, et al. "The Usage of a Simplified Self-titration Dosing Guideline for Insulin Detemir in Patients Type 2 Diabetes - Results of the 303 Algorithm Study." Oral presentation (abstract # 197-OR) at: 67th annual meeting of the American Diabetes Association, Chicago, IL, June 23-26, 2007.
(2) Facts on File, Novo Nordisk, Princeton, NJ.
(3) Weight Control Information Network. "Do You Know the Health Risks of Being Overweight?" http://win.niddk.nih.gov/publications/health_risks.htm. Web site accessed May 2007.
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