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Added benefit of saxagliptin/metformin combination is not proven
Date:4/29/2013

The fixed combination of the drugs saxagliptin and metformin (Komboglyze) has been approved in Germany since November 2011 for the treatment of type 2 diabetes mellitus. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this fixed combination product offers an added benefit versus the current standard treatment. Such an added benefit cannot be derived from the dossier, however, as the manufacturer did not submit any relevant data.

Dual or triple combination therapy possible

The combination is an option for adult patients who do not benefit sufficiently from the commonly used drug metformin or who are already taking saxagliptin and metformin as individual tablets. It can also be used together with insulin if insulin and metformin are insufficient.

Glibenclamide or glimepiride as the appropriate comparator therapy

The Federal Joint Committee (G-BA) has specified metformin in combination with a sulfonylurea (glibenclamide or glimepiride) as the appropriate comparator therapy for saxagliptin/metformin. The triple combination therapy, i.e. saxagliptin/metformin and insulin, was to be compared with metformin and human insulin.

Dual combination: Manufacturer compared saxagliptin/metformin with glipizide

Regarding the dual combination therapy, the manufacturer deviated from the G-BA's specifications and submitted data from an approval study in which the patients in the control group did not receive glibenclamide or glimepiride, but another sulfonylurea, namely glipizide. However, this drug has no longer been approved in Germany since 2007. In addition, the manufacturer did not provide sufficient explanation in its dossier that glipizide is equivalent to the other two sulfonylureas.

Study on triple combination is unsuitable

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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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