Levemir® Approved In Europe For Use In Combination With Oral Antidiabetic Drugs

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Mar 2007 - 0:00 PDT


Novo Nordisk today announced that the European Commission has approved Levemir® (insulin detemir) for once-daily use in combination with oral antidiabetic drugs (OADs).

Levemir® initiated once daily significantly improves blood glucose levels, with less weight gain compared to NPH insulin and insulin glargine.(1-3) Levemir® is the first long-acting insulin associated with less weight gain and the weight benefit of Levemir® has been shown to increase with increasing baseline body mass index (BMI).(4) This makes Levemir® an appealing long-acting insulin for initiating early insulin treatment for people with type 2 diabetes.

"Our findings showed that not only did Levemir® given once daily improve glycaemic control, but unlike many other forms of insulin, it actually led to weight loss and this benefit was even greater for the more obese people with diabetes," says Dr Anne Dornhorst, Department of Metabolic Medicine, Imperial College, London, and leading investigator of the PREDICTIVE™ study.(5)

The weight benefit of Levemir® is both confirmed by clinical trials and in clinical practice. Thirteen out of thirteen trials have consistently confirmed significantly less weight gain with Levemir® compared to NPH insulin.(1,2,6-16) In a clinical practice study the fact is that patients treated with Levemir® did not gain weight.(4)

Furthermore, Levemir® provides effective blood glucose control with a reduced risk of hypoglycaemia (too low blood sugar), which is one of the most serious concerns for people with diabetes. A recent trial shows that Levemir® reduces the relative overall risk of hypoglycaemia by 53% while the relative risk of nocturnal hypoglycaemic events is reduced by 65% compared to NPH insulin.(1) Therefore, the new approval of Levemir® once-daily use in combination with OADs provides a new treatment option for people with type 2 diabetes who have difficulties in maintaining acceptable blood glucose levels when treated with OADs alone.

About Levemir®

Levemir® is a long-acting modern insulin (insulin analogue) that covers the body's basal insulin need. Levemir® is released gradually and therefore it entails less fluctuation in blood glucose levels and better predictability com­pared to traditional long-acting NPH insulins. Levemir® delivers up to 24-hour duration of action with a single daily dose.(17) The dose should be taken in the evening, at dinner or before bedtime.(1) Injections can easily be managed with the simple and discreet FlexPen®, prefilled insulin pen.(18,19)

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.

References

1 - Philis-Tsimikas A et al. Study 1632. A comparison of once-daily insulin detemir with NPH insulin when added to oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006; 28: 1569-81.

2 - Hermansen K, et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006; 29(6): 1269 74.

3 - Rosenstock J, Davies M, Home PD, Larsen J, Tamer SC, Schernthaner G. Insulin Detemir Added to Oral Anti-Diabetic Drugs in Type 2 Diabetes Provides Glycemic Control Comparable to Insulin Glargine with Less Weight Gain. Diabetes 2006; 55: A132.

4 - Dornhorst A et al. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE™ European cohort. Intl Journal of Clin Practice 2007.

5 - PREDICTIVE™ (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation) is a multinational, open-label, prospective, observational study to evaluate the safety and efficacy of Levemir® in people with type 1 and type 2 diabetes in 19 countries.

6 - Russell-Jones D, Bolinder J, Simpson R et al. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type 1 diabetes mellitus using a basal-bolus regimen. Clin Ther 2004; 26(5): 724 36.

7 - Vague P, Selam JL, Skeie S et al. Insulin detemir is associated with more predictable glycaemic control and reduced risk of hypoglycaemia than NPH insulin in patients with type 1 diabetes on a basal bolus regimen with premeal insulin aspart. Diabetes Care 2003; 26(3): 590 596.

8 - De Leeuw I, Vague P, Selam JL et al. Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin. Diabetes Obes Metab 2005; 7(1): 73 82.

9 - Pieber T, Grill V, Kristensen A et al. Comparison of three multiple injection regimens for Type 1 diabetes: morning plus dinner or bedtime administration of insulin detemir vs. morning plus bedtime NPH insulin. Diabetic Medicine 2005; 22(7): 850 57.

10 - Standl E, Roberts A, Lang H et al. The 12-month efficacy and safety of insulin detemir and NPH insulin in basal-bolus therapy for the treatment of type 1 diabetes. Diabetes Technology Therapeutics 2004; 6(5): 579 88. 11 - Home P, Bartley P, Russell-Jones D et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabetes Care 2004; 27(5): 1081 1087.

12 - Hermansen K, Fontaine P, Kukolja KK et al. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal bolus therapy for patients with type 1 diabetes. Diabetologia 2004; 47(4): 622 629.

13 - Rašlova K, Bogoev M, Raz I et al. Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes. Diabetes Res Clin Pract 2004; 66(2): 193 201.

14 - Haak T, Tiengo A, Draeger E et al. Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes. Diabetes Obes Metab 2005; 7(1): 56 64.

15 - Robertson K, Schönle E, Gucev Z et al. Insulin detemir compared with NPH insulin in children and adolescent with type 1 diabetes, Diabetes Medicine 2007; 24(1):27

16 - Pieber TR, Treichel H-C, Robertson LI, et al. Insulin detemir plus insulin aspart is associated with less risk of major as well as nocturnal hypoglycaemia than insulin glargine plus insulin aspart at comparable levels of glycaemic control in type 1 diabetes. Diabetic Medicine 2007. In press.

17 - Klein O, Lynge J, Endahle L, et al. Insulin detemir and insulin glargine: similar time-action profiles in subjects with type 2 diabetes. American Diabetes Association: 66th Annual Scientific Sessions, 2006, Washington DC, Oral presentation 325-OR.

18 - Lawton S. Diabetes 2001; 50(Suppl 2): A440.

19 - Asakura T. Clin Ther/New Technology 2005; Abstract 2069-PO.

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