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Why has Forxiga been approved? The CHMP concluded that Forxiga was shown to be effective in lowering blood glucose levels in patients with type-2 diabetes, when given alone or in combination with other antidiabetes medicines with different mechanisms of actions. In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Forxiga.
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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When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). -
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