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New insulin detemir shows important benefits over existing basal insulin in treating diabetes (26 Aug 2003)

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Less variability in blood glucose, better glycaemic control, reduced risk of hypoglycaemia and no weight gain

Paris, France, 26 August 2003 – Insulin detemir, a new basal insulin analogue, currently under review by regulatory authorities in the EU and US, offers a number of important, potential advantages over other current basal insulins in treating people with diabetes, according to findings presented at the 18th International Diabetes Federation (IDF) Congress.

A new study has demonstrated that insulin detemir has a more consistent, predictable effect on blood glucose than insulin glargine and NPH (neutral protamine Hagedorn) insulin.[1] Other studies have shown that, compared to NPH insulin, insulin detemir resulted in better glycaemic control, reduced risk of hypoglycaemia, no weight gain and greater flexibility in timing of administration.[2],[3]

Taken together, these findings add to the growing body of evidence showing that insulin detemir offers clinical advantages over NPH insulin in providing more consistent and predictable blood glucose levels and improved glycaemic control without weight gain. Insulin detemir is likely to become an important tool in the treatment of both type 1 and type 2 diabetes.

Unique mechanism of protraction

Insulin detemir is a basal insulin analogue that provides more predictable and consistent control of blood glucose levels (glycaemic control).10  The molecule has a fatty acid attached, enabling it to bind to albumin within the subcutaneous tissue and bloodstream and release insulin detemir at a slow, consistent rate. This unique method of prolonging action (scientifically known as protraction) results in more predictable day-to-day control of blood glucose levels [4],[5],[6],[7],[8] and a reduced risk of hypoglycaemia.[4],[5],[9],[10] Compared to insulin detemir the two currently available basal insulins –  NPH insulin and insulin glargine – produce a more variable blood glucose response.

Studies and findings

One of the studies presented at the conference is the first to systematically compare the properties of insulin detemir, NPH insulin and insulin glargine by examining their action profiles (pharmacodynamics) through measuring variability in glucose response from day to day as well as insulin concentrations in the blood (pharmacokinetics) in people with type 1 diabetes.[1] Insulin detemir showed less variability in insulin action and insulin concentrations than both insulin glargine and NPH insulin, thus indicating that insulin detemir provides a more predictable therapeutic effect.

The risk of hypoglycaemia was calculated for the three treatments, based on the probability of an individual experiencing double the effect on blood glucose when given the same insulin dose on a different day. The risk of hypoglycaemia for insulin detemir was 0.1%, while for NPH insulin and insulin glargine the risk was dramatically higher: 6.5% and 2.7% respectively.[1]

A further study confirms that a basal-bolus regimen of insulin detemir plus the rapid-acting insulin analogue, insulin aspart, provided improved and more consistent glycaemic control as well as a reduced risk of hypoglycaemia compared to a conventional regimen of NPH insulin plus short-acting human insulin.[11] Designed to mimic natural insulin release and provide a high level of glycaemic control, a basal-bolus regimen consists of bolus injections of short-acting insulin – in this study, insulin aspart – with each meal to control the blood glucose surge following food consumption. In addition, a basal injection of intermediate- or long-acting insulin – in these studies, insulin detemir – controls blood glucose levels between meals and during the night.

The insulin detemir/insulin aspart group demonstrated:

  • 25% lower overall risk of hypoglycaemia [p=0.014] and 85% lower overall risk of  nocturnal hypoglycaemia [p<0.001], after adjustment for change in HbA1c;


  • lower levels of HbA1c (7.88% vs 8.11%, p<0.001);


  • lower morning and postprandial blood glucose levels;


  • less variation in individual participants’ fasting blood glucose levels; and


  • 1.0 kg lower body weight, after adjustment for baseline and change in HbA1c (p<0.001).


Two other studies showed similar findings of superiority of insulin detemir compared to NPH insulin as part of a basal-bolus regimen, and further showed that insulin detemir allows for flexibility in the timing of administration. In both studies, all participants received insulin aspart as the mealtime, bolus insulin. Both studies showed that, regardless of timing of administration, insulin detemir, compared to NPH insulin, was associated with lower levels of fasting blood glucose, less variability in fasting blood glucose for each participant, no weight gain and lower night-time blood glucose profiles. Collectively, the two studies concluded that insulin detemir can be flexibly administered at morning and bedtime, morning and dinner or at fixed 12-hour intervals, while providing predictable glucose control.[3],[4]

“Flexibility in the timing of insulin dosing is important for people with diabetes, and these recent studies show that in addition to allowing this flexibility, insulin detemir also provides better glycaemic control compared with NPH insulin,” commented Professor Kjeld Hermansen, Head of Department of Endocrinology and Metabolism, Aarhus University Hospital, Denmark. “Equally important is the fact that the insulin analogues – insulin aspart and insulin detemir – are now proven to be superior to conventional insulins in a basal-bolus regimen in terms of improved glycaemic control, fewer hypoglycaemic events and no weight gain,” he adds.

Current basal insulins provide acceptable glycaemic control, but have a number of shortcomings. Insulin detemir represents significant clinical advantages due the improved and more predictable control, the lower risk of hypoglycaemia and no weight gain.

 

###

Notes to editors:

  • Insulin detemir was submitted to the EMEA and FDA for registration in Q4 2002.


  • Insulin detemir will be available in well-known advanced insulin delivery systems such as FlexPen®, designed with strong safety and simplicity features and overwhelmingly preferred by people with diabetes over other insulin delivery devices.


  • Novo Nordisk is a focused healthcare company. Novo Nordisk holds the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems.


  • Novo Nordisk is 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 18,000 people in 68 countries and markets its products in 179 countries. For further company information visit www.novonordisk.com

 

For further information please contact:

Media:

Investors:

Mike Rulis

Peter Haahr

Tel (direct): (+45) 4442 3573

 

Tel (direct): (+45) 4442 1207

 

Torben Bundgaard

Palle Holm Olsen

Tel (direct): (+41) 79 777 4319

Tel (direct): (+45) 4442 6175

 

 

 

Christian Kanstrup

 

Tel (direct): (+45) 4443 7801

 


References


[1]    Heise T, Nosek L, Draeger E, Stender A, Rønn BB, Heinemann L, Kapitza C., Heinemann L.  Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in subjects with type 1 diabetes.  Oral presentation OP 12 Insulin Therapy at the 18th annual meeting of the International Diabetes Federation, 25 August 2003, Paris, France.

[2]    Home P, Bartley P, Landin-Olsson M, Russell-Jones D, Hylleberg B, Draeger E.  Insulin detemir offers improved glycemic control, less weight gain, and flexible timing of administration compared to NPH insulin.  Oral presentation OP 14 Insulin Therapy at the 18th annual meeting of the International Diabetes Federation, 25 August 2003, Paris, France.

[3]    Pieber T, Grill V, Kristensen A, Draeger E.  Treatment with insulin detemir allows flexible timing of administration in subjects with type 1 diabetes.  Oral presentation OP 13 Insulin Therapy at: 18th annual meeting of the International Diabetes Federation, 25 August 2003, Paris, France.

[4]    Pieber TR, Plank J, Goerzer E, Sommer R, Wutte A, Sinner F, Bodenlenz M, Endahl L, Draeger E, Zdravkovic M. Duration of action, pharmacodynamic profile and between-subject variability of insulin detemir in subjects with type 1 diabetes. Diabetes 2002; 51:(Suppl.2):A53.

[5]    Russell-Jones D, BolinderJ, Simpson R.  Lower and more predictable fasting blood glucose and reduced risk of nocturnal hypoglycaemia with once daily insulin detemir vs. NPH in subjects with type 1 diabetes.  Diabetologia 2002; 45 (suppl. 2): A51.

[6]    Vague P, Selam J-L, Skeie S, DeLeeuw I, Elte JWF, Haahr H, Kristensen A, Draeger E.  Insulin detemir is associated with more predictable glycaemic control and lower risk of hypoglycaemia compared to NPH in subjects with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care 2003;26:590-596.

[7]    Roberts A, Bayer T, Munksgaard E, Lang H, Standl E.  Efficacy and safety of 6- month treatment with insulin detemir in type 1 diabetic patients on a basal/bolus regimen.  Diabetologia 2001;44 (Suppl 1):A207.and Diabetes 2001;50(2):A129.

[8]    Hermansen K, Madsbad S, Perrild H, Kristensen A, Axelsen M. Comparison of the soluble basal insulin analogue insulin detemir with NPH insulin. Diabetes Care 2001,VOL. 24: 296-301.

[9]    De Leeuw I, Vague P, Selam JL, Skeie S, Elte JWF, Lang H, Draeger E.  Lower risk of nocturnal hypoglycaemia and favourable weight development in type 1 diabetic subjects after 12 months treatment with insulin detemir vs. NPH insulin. Diabetologia 2002; 45 (suppl. 2); A257.

[10]   Standl E, Roberts A, Lang H. One-year safety and efficacy of insulin detemir in subjects with type 1 diabetes. Favourable weight development and risk reduction of nocturnal hypoglycaemia compared to NPH. Diabetologia 2002; 45 (suppl. 2): A51

[11]   Data on file. Novo Nordisk

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