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New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes

Monday, June 9, 2008 General News J E 4
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SAN FRANCISCO, June 8 A head-to-head studyannounced today at the American Diabetes Association (ADA) meetingdemonstrated that Levemir(R) (insulin detemir [rDNA origin] injection) can beused once-daily and had a comparable blood glucose response to insulinglargine over a 24-hour period in patients with type 2 diabetes.

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

A retrospective study using recent data from a large US health plandatabase showed that in addition to providing similar blood glucose responseas glargine, Levemir had no significant difference vs. glargine in dailyaverage 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 ofonce-daily Levemir versus a single daily dose of glargine to generate thefirst robust comparative data set of the two treatments.

"By finally establishing the efficacy profiles of these drugs in a directand fair comparison, we will help physicians choose the best possibletreatment for their patients," said Mads Krogsgaard Thomsen, Chief ScienceOfficer. "In clinical trials with patients with type 2 diabetes, once-dailyLevemir has repeatedly shown 24-hour glycemic control, improved HbA1c controland a low incidence of hypos, with the addition of a weight benefit. Forpeople 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 theblood glucose response of once-daily Levemir to glargine in a single dailydose over a 24-hour period using continual glucose monitoring system (CGMS),showing that Levemir had a comparable blood glucose response to insulinglargine.

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

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

Once basal blood glucose targets were achieved, CGMS readings for the last24-hour period were recorded and mean values were compared between treatmentsusing a single-tailed, paired t-test.

Levemir Shows Similar Daily Average Consumption versus Glargine

A retrospective analysis of insulin-naive patients with type 2 diabetesenrolled in a major US health plan compared daily average consumption (DACON)of and glycemic control with the insulins Levemir and glargine, along withassociated medical costs. Results showed that there was no difference in HbA1cvalues between Levemir and insulin glargine cohorts, and no significantdifference in DACON.

Researchers monitored insulin-naive patients with type 2 diabetes age 18and older who were enrolled in a large US health plan. Using propensity scorematching, it was found that 48 patients started insulin detemir therapy, and258 started insulin glargine therapy, over a six-month period. Besidesreducing selection bias due to observed baseline characteristics, propensityscore matching also ensures that patients in insulin detemir and insulinglargine cohorts have similar distribution of the baseline characteristics.This ensured that patients included in the insulin detemir a
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