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German Study about fast-acting Insulin Analogues

Fast-acting Insulin Analogues with Diabetes mellitus Type 1: Preliminary Report No proof of advantages over human insulin

The German Institute for Quality and Cost Effectiveness in the Health Care Sector (IQWiG) has published its preliminary report “Fast-acting Insulin analogues with Diabetes mellitus Type 1”. There is now a 4-week period within which interested persons and institutions may submit their written statements. Points in the submissions which are unclear shall be clarified in a verbal discussion. Following this, the report shall be revised and passed on to the Joint Government Committee (G-BA). The G-BA shall base its decisions [regarding placement of the drugs on the health insurance list] on the IQWiG recommendations.

The preliminary report is part of the G-BA’s comprehensive mandate to IQWiG which consists of assessing important therapy options for diabetics. A final report on the three fast-acting analogue insulins allowed in Germany was already issued in February and concentrated on patients with type 2 diabetes. Just as with the patients with type 2 diabetes, the researchers found no evidence of any significant advantages for type 1 diabetics with any of the three fast-acting insulin analogues allowed in Germany (Aspart, Glulisin, Lispro) compared to human insulin. During the course of their research, the IQWiG experts came across unpublished studies. Three of the studies were financed by NOVO Nordisk, who manufactures the insulin analogue Aspart. The company had, however, rejected IQWiG’s request to make the data from their research available for the study. It is a unanimous and internationally agreed basic ethical principle of medical research that research results should be published swiftly.

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