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Dapagliflozin is not suitable for people who have type 1 diabetes, have low kidney function, are galactose intolerant, have low salt levels in their body, are under the age of 18 or over the age 75, people on a course of Actos (pioglitazone) or loop diuretics.
How has Forxiga been studied? The effects of Forxiga were first tested in experimental models before being studied in humans. Forxiga on its own has been compared with placebo (a dummy treatment) in two studies in 840 patients. A third study compared Forxiga with a sulphonylurea (glipizide), both taken in combination with metformin in 814 patients. Four other studies compared Forxiga with placebo, when used as an add-on to either metformin, a sulphonylurea (glimepiride), a thiazolidinedione or insulin in 2,370 patients.
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In all of the studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. What benefit has Forxiga shown during the studies? Forxiga was more effective than placebo at reducing the levels of HbA1c when used alone and in combination with other antidiabetes medicines. When Forxiga was used on its own at a dose of 10 mg, it decreased HbA1c levels by 0.66% more than placebo after 24 weeks. When Forxiga was added to other antidiabetes medicines, Forxiga 10 mg decreased HbA1c levels by 0.54-0.68% more than placebo after 24 weeks. When compared with a sulphonylurea, Forxiga was at least as effective and both medicines reduced HbA1c levels by 0.52% after 52 weeks.