IDDT challenges insulin manufacturer over discontinuation of Semilente MC insulin

3 November 2008

The Insulin Dependent Diabetes Trust (IDDT) continues to voice its concern over Novo Nordisk’s announcement that it plans to discontinue the manufacture of Semilente MC by the end of 2008.

Semilente has a high therapeutic standing particularly, in the area of paediatric diabetology - and as a rule, children and teenagers with Type 1 diabetes who show a distinctive “dawn phenomenon,” (i.e. very high blood sugars in the early morning) are treated with Semilente. There are currently thousands of patients being treated with Semilente around the world and experience has shown that patients using Semilente, have significantly better morning blood sugars than with other insulins. However, no statistically relevant studies on transfers from Semilente to Glargin, NPH or Detemir insulins have yet been published. Although Semilente’s superiority over NPH insulin was scientifically proven in the 1990’s. (Ref 1,2).

IDDT’s co-chair, Jenny Hirst commented, “the planned discontinuation of Semilente is unique in the history of pharmaceutics – as this is the first time that a safe, effective, successful drug (which has been established for several decades) is being withdrawn by a manufacturer without any replacement drug with an equivalent, or superior pharmacokinetics and pharmacodynamics being made available. Nor is there any cheaper insulin available to treat the same “dawn phenomenon” indication.”

She continued, “we demand that relevant and informative studies on the transfer of children and teenagers, with the ‘dawn phenomenon,’ onto other insulins be carried out before Semilente is discontinued. There are no long-term studies available for newer drugs such as Detemir insulin, but there are studies on the side effects such as a Type 3 allergy. (Ref 3)

In view of the considerable number of people likely to be affected if this insulin is discontinued, and the current lack of therapeutic alternatives, we demand that the manufacturer shows more responsibility in the sector of paediatric diabetology. And if they cannot guarantee to extend the supply of Semilente after the end of 2008, then arrangements should be put in place for another company to licence and continue to manufacture this insulin.

- ends -

Notes:

The Insulin Dependent Diabetes Trust is a registered charity and is concerned with listening to the needs of people who live with diabetes, understanding those needs and doing its utmost to offer help and support.
www.iddtinternational.org or email enquiries@iddtinternational.com

References:

1) Holl RW, Teller WM, Heinze E. Semilente insulin at bedtime is superior to NPH insulin for the suppression of the dawn-phenomenon in adolescents with Type-1-diabetes. Exp Clin Endocrinol Diabetes. 1996;104(5):360-4
2) Strasser D, Nutzi E, Spinas GA, Berger W. Treatment of early-morning hyperglycemia in Type 1 diabetics with amorphous zinc insulin (Seilente) at bedtime. Horm Res. 1993;39(5-6):173-8.
3) Darmon P, Casters V, Koeppel M-C, Petitjean C, Dutour A. Type III allergy to insulin Detemir. Diabetes Care 2005;28(12):2980.

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