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New Data From Head-to-Head Study Confirms Insulin Detemir Is As Effective as Glargine

SAN FRANCISCO, June 8 /PRNewswire-FirstCall/ -- A head-to-head study announced today at the American Diabetes Association (ADA) meeting demonstrated that Levemir(R) (insulin detemir [rDNA origin] injection) can be used once-daily and had a comparable blood glucose response to insulin glargine over a 24-hour period in patients with type 2 diabetes.

"Our study reinforces that once-daily Levemir has a similar 24-hour action profile as once-daily glargine," said Professor Allen B. King, Diabetes Care Center, Salinas, CA, whose research compared 24-hour blood glucose response of Levemir and glargine.

A retrospective study using recent data from a large US health plan database showed that in addition to providing similar blood glucose response as glargine, Levemir had no significant difference vs. glargine in daily average consumption and diabetes related pharmacy costs.

Novo Nordisk Announces the Decision to Conduct the First and Only Safety and Efficacy Study to Compare Once-Daily Levemir(R) vs. Once-Daily Glargine Novo Nordisk also announced today the first and only full scale study of once-daily Levemir versus a single daily dose of glargine to generate the first robust comparative data set of the two treatments.

"By finally establishing the efficacy profiles of these drugs in a direct and fair comparison, we will help physicians choose the best possible treatment for their patients," said Mads Krogsgaard Thomsen, Chief Science Officer. "In clinical trials with patients with type 2 diabetes, once-daily Levemir has repeatedly shown 24-hour glycemic control, improved HbA1c control and a low incidence of hypos, with the addition of a weight benefit. For people with diabetes, once-daily Levemir may offer an attractive package."

Levemir Shows Comparable Blood Glucose Response versus Glargine
The head-to-head, randomized, double-blind crossover study compared the blood glucose response of once-daily Levemir to glargine in a single daily dose over a 24-hour period using continual glucose monitoring system (CGMS), showing that Levemir had a comparable blood glucose response to insulin glargine.

Patients with type 2 diabetes using basal insulin without bolus insulin (N=35) were randomized to receive a single daily injection of Levemir or glargine at 8 p.m. for one week in order to achieve steady state levels of insulin in the body. At the end of the week, subjects were switched to the other insulin.

Both insulins were titrated to achieve blood glucose targets during a pre-specified basal period (12 p.m. to 6 a.m.). No food was eaten between 6 p.m. to ~7 a.m. in order to obtain accurate basal readings.

Once basal blood glucose targets were achieved, CGMS readings for the last 24-hour period were recorded and mean values were compared between treatments using a single-tailed, paired t-test.

Levemir Shows Similar Daily Average Consumption versus Glargine
A retrospective analysis of insulin-naive patients with type 2 diabetes enrolled in a major US health plan compared daily average consumption (DACON) of and glycemic control with the insulins Levemir and glargine, along with associated medical costs. Results showed that there was no difference in HbA1c values between Levemir and insulin glargine cohorts, and no significant difference in DACON.

Researchers monitored insulin-naive patients with type 2 diabetes age 18 and older who were enrolled in a large US health plan. Using propensity score matching, it was found that 48 patients started insulin detemir therapy, and 258 started insulin glargine therapy, over a six-month period. Besides reducing selection bias due to observed baseline characteristics, propensity score matching also ensures that patients in insulin detemir and insulin glargine cohorts have similar distribution of the baseline characteristics. This ensured that patients included in the insulin detemir and insulin glargine cohorts have similar demographic and clinical profiles. Primary outcomes included DACON of insulin detemir or insulin glargine, A1C levels following initiation of insulin therapy, and overall and diabetes-related cost.

Following the six-month analysis period, adjusted DACON for basal only insulin detemir and insulin glargine cohorts were 29.3 and 29.6 units/day respectively (p=0.93). No significant difference in diabetes-related pharmacy cost was observed ($1,277 vs. $1,149; p=0.23).

About Levemir(R) (insulin detemir [rDNA origin] injection)
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 diluted 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 from other intermediate or long-acting insulin preparations. The dose of Levemir may need to be adjusted in patients with renal or hepatic impairment.

Source: Novo Nordisk

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Decision supported by data from more than 4,000 patients