Novapio is indicated as second-line or third-line medicament for the treatment of type 2 diabetes as described below:
in monotherapy — for adult patients (especially overweight) with insufficient physical activity and dietary compensation, to whom metformin cannot be given for intolerance or contraindication.
in oral therapy in combination
with metformin for adult patients (particularly overweight) with inadequate glycemic control despite the maximum tolerated dose of metformin in oral monotherapy,
with sulphonylurea for adult patients with insufficient glycemic control despite the maximum tolerated dose of sulphonylurea in oral monotherapy, only for patients who cannot receive metformin due to intolerance or contraindications,
in oral therapy in triple-combination:
with metformin and a sulphonylurea for adult patients (particularly overweight) with inadequate glycemic control with dual oral therapy.
Novapio is also indicated in combination with insulin for adult patients with type 2 diabetes with insufficient glycemic control by insulin itself where metformin cannot be used due to contraindications or intolerance.
After initiation of the treatment with Novapio, patients’ response to the treatment should be assessed after 3-6 months (eg reduction of HbA1c). Novapio should not be used anymore if patients do not respond adequately. Due to the potential risk of long-term treatment, the duration of the benefit of the treatment should be confirmed during routine follow-ups.
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