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Long-acting insulin analogues in type 2 diabetes: advantage over human insulin not proven
Date:4/3/2009

n patients who also use oral antidiabetics. In addition, the 5-year study provides an indication that in patients using insulin glargine, severe hypoglycaemia occurs less frequently than in those using NPH insulin.

In the direct comparison of the two LAIAs, neither drug was clearly better than the other. However, study participants who used insulin detemir discontinued the study more often due to adverse events than those using insulin glargine. On average, patients in the detemir group put on less weight than those in the glargine group. However, the differences were small (0.9-1.3 kg). As the studies only lasted 6-12 months, it is unclear anyway whether this effect is long term.

Manufacturers provide previously unpublished data

Both manufacturers of LAIAs, Sanofi-Aventis (insulin glargine) and Novo Nordisk (insulin detemir), agreed to provide IQWiG with previously unpublished data during the preparation of the report. Data subsequently requested by IQWiG were supplied. These data referred in part to studies still completely unpublished and in part to additional information (clinical study reports) on comparative clinical trials already published. In addition, the manufacturers agreed that all of these data could be documented in the final report. A large amount of previously unpublished data could thus be incorporated in the final report.

During the course of the hearing procedure on the preliminary report, the manufacturers also supplied further analyses based on individual patient data (IPD). However, these data only changed the conclusions of the preliminary report in a few cases.

Procedure of report production

The preliminary results (preliminary report) were published by IQWiG at the end of March 2008 and interested parties were invited to submit comments. Following the commenting procedure, the preliminary report was revised and the final report sent to the contracting agency, the Feder
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Contact: Dr. Anna-Sabine Ernst
info@iqwig.de
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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