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Characterization of the open-label lead-in period of two randomized controlled phase 3 trials evaluating dapagliflozin, saxagliptin, and metformin in type 2 diabetes

Diabetes Therapy Jun 01, 2018

Mathieu C, et al. - Authors attempted to investigate the utility of sequential vs dual add-on approaches in patients who have type 2 diabetes and inadequate glycemic control with metformin therapy alone, they characterized the efficacy and safety of dual therapy with dapagliflozin or saxagliptin added to metformin in the open-label lead-in periods of two phase 3 trials that evaluated triple therapy in patients with inadequately controlled type 2 diabetes. They reported that dual therapy improved glycemic control and was well tolerated. However, most patients needed additional therapy to further improve glycated hemoglobin (HbA1c) towards target, recommending that an early move to triple therapy with oral glucose-lowering drugs rather than a stepwise approach could be useful for patients with high HbA1c levels on metformin therapy.
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