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Levemir® demonstrates a 24-hour duration of action and significant weight loss in obese patients – new studies announced

Rome, Italy – Data released today at the European Association for the Study of Diabetes (EASD) Annual Meeting concludes that Levemir® (insulin detemir [rDNA origin] injection) is a once-daily treatment for diabetes patients after demonstrating a 24-hour duration of action in both type 1 and type 2 diabetes.1,2 Results from two other studies announced today reveal that Levemir® can lead to significant weight loss for insulin-naïve patients with type 2 diabetes3, and provides a similar blood glucose response as glargine with no significant difference in daily average consumption (DACON) or diabetes-related pharmacy costs4.

Once-daily Levemir® demonstrates 24-hour duration of action

The randomised, double-blind study by Bock et al1 demonstrates that once-daily Levemir® is effective over a 24-hour period (mean duration 23.3 hours) in type 1 diabetes patients and has a more consistent duration of action compared to insulin glargine1. This reflects other published research in which patients with type 2 diabetes achieve 24-hour glycaemic control with once-daily Levemir®.5

Weight benefit beyond glycaemic control

In another study presented today, a subset analysis of the PREDICTIVE™ study3, it was shown that insulin-naïve patients with type 2 diabetes and a BMI >35 kg/m2 experienced an average weight loss of up to -3.46 kg after 52 weeks of Levemir® treatment3.

“This data confirms that Levemir® provides a significant weight benefit for overweight or obese patients who are being initiated into insulin treatment. This weight advantage is important because weight gain is a common barrier to insulin initiation,” said Professor Helene Hanaire, Hospital Rangueil, Toulouse, France. “This weight advantage combined with the efficacy and convenience of Levemir®, which can be taken once daily, makes it a good option for overweight or obese diabetes patients who need to take insulin.”

Levemir® shows similar daily average consumption versus glargine

A retrospective analysis of insulin-naïve patients with type 2 diabetes enrolled in a major US health plan compared daily average consumption (DACON) of and glycaemic 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 DACON4.

About Levemir® (insulin detemir [rDNA origin] injection)

Levemir® (insulin detemir [rDNA origin] injection) is a long-acting modern insulin (insulin analogue) 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 hyperglycaemia. Levemir® has a relatively flat action profile with up to 24-hour duration of action. It can be added to oral antidiabetic agents, or used in combination with rapid-acting insulin. Levemir® is available in FlexPen®, a prefilled insulin pen for easy, discreet dosing, and in vials. The dose should be taken in the evening, at dinner or before bedtime. Levemir® has been available for use in Europe since March 2004 and is currently approved in more than 50 countries worldwide.

Prescribing information for Levemir® is available by contacting Novo Nordisk or
visiting novonordisk.com.

Levemir® and FlexPen® are registered trademarks of Novo Nordisk A/S.

Novo Nordisk is a healthcare company and a world leader in diabetes care. 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 approximately 26,300 employees in 80 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 more information, visit novonordisk.com.

Further information:

Abstract Summaries

Bock G et al, Pharmacodynamics and pharmacokinetics of long-acting insulin analogues detemir and glargine after 7 days of use and after its first administration in subjects with type 1 diabetes – this randomised, double-blind clamp study investigated the pharmacodynamics and pharmacokinetic properties of detemir and glargine after a single dose and under steady state conditions after seven once-daily injections with prolonged glucose clamp experiments in patients with type 1 diabetes. Thirty six patients were randomised to receive 0.4 U/kg of either detemir or glargine s.c. The duration of action (insulin injection to end of insulin action) was 23.3 hours (range 10.5 – 29.0) for detemir and 27.1 hours for glargine (range 4.0 – 30.0) after multiple dosing. The end of insulin action after a single dose was earlier for glargine (19.8 hours) than for detemir. A larger variability for glargine was seen during both clamps in comparison to detemir.

Hanaire H et al, Insulin-naïve patients with type 2 diabetes and higher BMI experience weight loss when initiated onto insulin detemir: 12-week, 26-week and 52-week follow-up data from PREDICTIVE™ - this trial was a subset analysis of the multi-national PREDICTIVE study, and evaluated weight change associated with insulin detemir in patients treated over 12, 26 or 52 weeks. After 12 weeks, patients lost ~0.6 kg of weight (SD=3.4kg, p<0.0001) when initiated onto detemir and after 26 and 52 weeks patients on average lost a small (non-significant) amount of weight. However, after stratification according to BMI, it was found that those in the highest BMI categories (=30 kg/m2) lost significant weight when initiated onto insulin detemir. Those with a BMI >35 kg/m2 experienced an average weight loss of -1.52 kg after 12 weeks, -1.20 kg after 26 weeks and -3.46 kg after 52 weeks.

Borah B et al, Comparative analysis of treatment outcomes of patients on insulin detemir (Levemir®) and insulin glargine (Lantus®) – this trial assessed the differences in glycaemic control, daily average consumption (DACON) and overall and diabetes-related costs associated with glargine and detemir. The study looked at 48 detemir patients and 258 glargine patients. The results showed that there were no significant differences in adjusted DACON or HbA1c between the detemir and glargine cohorts. However, adjusted diabetes-related costs and total medical costs for detemir patients were lower than the glargine cohort ($2,262 vs. $3,049; p<0.03) and ($707 vs. $1,510, p<0.03) respectively. Adjusted overall medical costs were not statistically different, but the trend also suggested lower costs for the detemir cohort ($2,319 vs $3,704; p=0.07). No differences in overall or diabetes-related pharmacy costs were observed.

King A et al, Daily blood glucose profiles in subjects with type 2 diabetes in a randomised, crossover, double-blind comparison of insulin detemir and insulin glargine – this study was designed to compare 24-hour glycaemic control with insulin detemir vs. insulin glargine using a continuous glucose monitoring system. Thirty-five type 2 diabetes patients were randomised to receive a single daily injection of detemir or glargine at 8pm for one week and switched to the other insulin the next week. All subjects achieved basal blood glucose targets in a mean of 3.65 days. Mean blood glucose values during the basal period and the entire 24-hour period were not significantly different between glargine and detemir, except at 2am (p<0.05). The study concluded that once-daily dosing of both treatments provided comparable glycaemic efficacy over a 24-hour period.

Heise T et al, Towards peakless reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies – this review of previous clamp studies aimed to assess available pharmacodynamic data of glargine and detemir as derived with the glucose clamp technique. It was found that, despite differences in methodological details, the results of most clamp studies were very consistent. Glargine and detemir both typically show a gentle rise and fall in glucose-lowering action over time. Duration of action of both analogues is dose dependent, but in the clinically relevant range of 0.35 – 0.8 U/kg both are close to 24-hours in people with type 1 diabetes and in excess of this in people with type 2 diabetes. While both analogues seemed to be very similar with regard to their mean shape of their pharmacodynamic profile and duration of action, detemir showed less within-subject variability in its metabolic effect. These results suggest that both glargine and detemir are suited to routine use in once-daily schedules in type 2 diabetes.

References

1.  Bock, G., et al. Pharmacodynamics and pharmacokinetics of long-acting insulin analogues detemir and glargine after 7 days of use and after its first administration in subjects with type 1 diabetes. Presented at the European Association for the Study for Diabetes, September 2008.

2.  King, A B., et al. A randomized, crossover, double-blind comparison of insulin detemir and insulin glargine daily blood glucose profiles in subjects with type 2 diabetes. Presented at the American Diabetes Association’s 68th Annual Scientific Sessions, June 2008 and at the European Association for the Study for Diabetes, September 2008.

3.  Hanaire, H., et al. Insulin-naïve patients with type 2 diabetes and higher BMI experience weight loss when initiated onto insulin detemir: 12-week, 26-week and 52-week follow-up data from PREDICTIVE™. Presented at the European Association for the Study for Diabetes, September 2008.

4.  Borah, B., et al. Comparative analysis of treatment outcomes of patients on insulin detemir (Levemir®) and insulin glargine (Lantus®). Presented at the American Diabetes Association’s 68th Annual Scientific Sessions, June 2008 and at the European Association for the Study for Diabetes, September 2008.

5.  Heise, T, Pieber, T. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes, Obesity and Metabolism 2007; 9: 648-659.