Bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes in adults: A 24‐week, randomized, double‐blind, placebo‐controlled trial
Primary result · Mean change in HbA1cResult — go to the resultDifference −0.53 % 95% CI −0.74% to −0.32%Authors' conclusion
Bexagliflozin produced clinically meaningful improvement in glycaemic control, estimated glomerular filtration rate and SBP when added to metformin in a population of adults with diabetes.
Study context
- Population
- Adults with T2D on metforminrandomized
- Participants
- 317 adults
- Comparison
- Bexagliflozin vs placebo, added to metformin
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, 24-week, open-label arm (HbA1c >10.5%) analysed separately
- Double-blind
- Placebo-controlled
- 24-week
- Open-label arm (HbA1c >10.5%) analysed separately
Primary result
Mean change in HbA1c
Difference
−0.53 %
95% CI −0.74% to −0.32%
P < 0.0001
Change by group
Bexagliflozin
−1.09
mean · 95% CI −1.24%–-0.94% · %
Placebo
−0.56
mean · CI −0.71%–-0.41% · %
Bexagliflozinvs Placebo
difference −0.53 % (95% CI −0.74% to −0.32%); P < 0.0001
As reported in the abstract
Secondary outcomes
| Outcome | Intergroup difference (%) (CI) | P value | |
|---|---|---|---|
| Change in HbA1c excluding observations after rescue medication | −0.70 (−0.92 to −0.48) | P < 0.0001 | |
| −1−0.500.5Difference, % (linear scale) |
| Outcome | Placebo-adjusted change (mmHg) (CI) | P value | |
|---|---|---|---|
| Placebo-adjusted change from baseline SBP | −7.07 (−9.83 to −4.32) | P < 0.0001 | |
| −10−505Difference, mmHg (linear scale) |
| Outcome | Placebo-adjusted change (mmol/L) (CI) | P value | |
|---|---|---|---|
| Placebo-adjusted change from baseline FPG | −1.35 (−1.83 to −0.86) | P < 0.0001 | |
| −2−101Difference, mmol/L (linear scale) |
| Outcome | Placebo-adjusted change (kg) (CI) | P value | |
|---|---|---|---|
| Placebo-adjusted change from baseline body mass | −2.51 (−3.45 to −1.57) | P < 0.0001 | |
| −4−202Difference, kg (linear scale) |
Change in HbA1c, open-label arm (HbA1c >10.5%)
- Open-label change in HbA1c
- −2.82% (CI −2.41% to −3.23% as printed: −3.23%, −2.41%)
- Analysed separately
Safety
Adverse events
Adverse events
- Fewer subjects with serious adverse events with bexagliflozin
Original publication
Bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes in adults: A 24‐week, randomized, double‐blind, placebo‐controlled trial. Diabetes Obes Metab. Published 6 July 2023. doi:10.
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