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

>Regarding the combination with insulin, the manufacturer submitted a study that directly compared saxagliptin/metformin and insulin with metformin und human insulin. But the results of this study cannot be used for the assessment of the added benefit.

The main reason for this is that the insulin therapy could not be tailored sufficiently to the individual patient in the first treatment phase: even though their current insulin therapy was insufficient, patients were neither supposed to change the insulin nor to adapt the dose. But to be able to draw conclusions about the added benefit, the combination of saxagliptin/metformin and insulin would have to be compared with other strategies for optimizing treatment, for example optimizing insulin use.

Not tailoring treatment to the individual patient does not meet the current standard of diabetological practice anyway. Instead, insulin therapy is optimized for the individual patient so that hyperglycaemia and hypoglycaemia do not occur in the first place. So in the study, insulin was not used in a way that would be necessary and appropriate in this indication.

Therefore, there are no study results for either of the two therapeutic indications of the fixed combination saxagliptin/metformin from which an added benefit could be derived.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.


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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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