Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Once Daily Empagliflozin 25 mg for the Treatment of Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass
Authors' conclusion
Empagliflozin 25 mg reduces glucose excursions but not hypoglycemia in individuals with PBH.
Study context
- Population
- Adults with postbariatric hypoglycemia (PBH) after RYGBcrossover
- Participants
- 22 adults
- Comparison
- Empagliflozin 25 mg once daily vs placebo over 20 days
- Primary endpoint
- Amplitude of plasma glucose excursion (peak to nadir) during a mixed-meal tolerance test (MMTT)
Methodological detailsdouble-blind, placebo-controlled, crossover
- Double-blind
- Placebo-controlled
- Crossover
Primary result
As reported in the abstract
Amplitude of glucose excursion during MMTT
P = 0.807
Further findings
Time with CGM values >10.0 mmol/L · reduced with empagliflozin
P = 0.009
Time with CGM values <3.0 mmol/L
P = 0.457
Mean
| Outcome | Empagliflozin | Placebo | P value |
|---|---|---|---|
| CGM-based mean amplitude of glucose excursion · 20-day periodLower with empagliflozin | 4.8 (SD 1.3) | 5.2 (SD 1.6) | P = 0.028 |
Recorded symptoms
- No significant difference in quantity and quality of recorded symptoms
Safety
| Outcome | Empagliflozin |
|---|---|
| Adverse events | |
| Drug-related | 3 |
Original publication
Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Once Daily Empagliflozin 25 mg for the Treatment of Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass. Diabetes Technol Ther. Published 5 June 2023. doi:10.
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