Stopped: Early terminated after prespecified interim analysis due to lack of efficacy. No relevant safety signals.
This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.
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Change in Quality of life (mental health; as assessed by the SF-36 mental health component score; MCS)
Timeframe: at baseline, at day 29 and at day 60 (+/- 10 days) after baseline
Change in Quality of life (physical health; as assessed by the SF-36 mental physical component score; PCS)
Timeframe: at baseline, at day 29 and at day 60 (+/- 10 days) after baseline
Hypoglycemic events defined as glucose values below 3.0 mmol/l
Timeframe: at 28 days after randomization