Insulin Detemir Is Associated With More Predictable Glycemic Control and Reduced Risk of Hypoglycemia Than NPH Insulin in Patients With Type 1 Diabetes on a Basal-Bolus Regimen With Premeal Insulin Aspart
- Philippe Vague, MD, PHD1,
- Jean-Louis Selam, MD2,
- Svein Skeie, MD3,
- Ivo De Leeuw4,
- Jan W.F. Elte, MD, PHD5,
- Hanne Haahr, PHD6,
- Allan Kristensen, MSC6 and
- Eberhard Draeger, PHD6
- 1Hôpital de la Timone, Service Nutrition Endocrinologie et Maladies Metabolique, Marseilles, France
- 2Hotel Dieu, Service de Diabétologie, Paris, France
- 3Hjertelaget Research Foundation, Stavanger, Norway
- 4Department of Endocrinology, University of Antwerp, Antwerp, Belgium
- 5St. Franciscus Gasthuis, Rotterdam, the Netherlands
- 6Novo Nordisk A/S, Gladsaxe, Denmark.
OBJECTIVE—Insulin detemir is a soluble basal insulin analog with a unique mechanism of protracted action designed to reduce the variability associated with conventional basal insulins. This trial compared the glycemic control, risk of hypoglycemia, and effect on body weight of insulin detemir and NPH insulin in patients with type 1 diabetes treated with rapid-acting insulin aspart at meals.
RESEARCH DESIGN AND METHODS—This study was a 6-month multinational open parallel-group comparison conducted at 46 centers in five countries and included 448 patients with type 1 diabetes randomized 2:1 to insulin detemir or NPH insulin, respectively.
RESULTS—After 6 months, comparable HbA1c levels were found between the two treatment groups. Fasting plasma glucose tended to be lower in patients treated with insulin detemir, but this difference was not statistically significant (−0.76 mmol/l, P = 0.097). Within-subject variation in self-measured fasting blood glucose was lower with insulin detemir than with NPH insulin (SD 3.37 vs. 3.78 mmol/l, P < 0.001). Risk of hypoglycemia was 22% lower with insulin detemir than with NPH insulin (P < 0.05) and 34% lower for nocturnal (2300–0600) hypoglycemia (P < 0.005). Nightly plasma glucose profiles were smoother and more stable with insulin detemir (P = 0.05). Body weight was significantly lower with insulin detemir at the end of the trial (P < 0.001).
CONCLUSIONS—Treatment with insulin detemir resulted in more predictable glycemic control, with smoother plasma glucose profiles than NPH insulin and a significant reduction in the risk of hypoglycemia. The reduction in body weight with insulin detemir is a potential additional advantage. Regimens optimized for insulin detemir may be able to improve glycemic control beyond that possible with NPH insulin.
- DCCT, Diabetes Control and Complications Trial
- FPG, fasting plasma glucose
- IAsp, insulin aspart
- SMBG, self-measured blood glucose
Address correspondence and reprint requests to Prof. Philippe Vague, Hôpital de la Timone, Service Nutrition Endocrinologie et Maladies Metabolique, 264 Rue Saint Pierre, 13385 Marseilles Cedex 05, France. E-mail:.
Received for publication 9 May 2002 and accepted in revised form 11 November 2002.
I.D.L. is a paid consultant for Novo Nordisk, Belgium, and has received laboratory funds from Novo Nordisk. H.H., A.K., and E.D. hold stock in Novo Nordisk. E.D. also holds stock in Aventis.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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