A 96‐week, double‐blind, randomized controlled trial comparing bexagliflozin to glimepiride as an adjunct to metformin for the treatment of type 2 diabetes in adults
Primary result · Change in HbA1cResult — go to the resultIntergroup difference −0.55 mmol/mol 95% CI −2.30 to 1.20Authors' conclusion
Bexagliflozin was noninferior to glimepiride in lowering HbA1c, was superior to glimepiride for decreases in body mass and SBP, and was associated with significantly fewer hypoglycaemic events than glimepiride. A favourable effect on eGFR was observed.
Study context
- Population
- Adults with T2D taking metformin, HbA1c 53–91 mmol/mol [7.0%–10.5%]
- Participants
- 426 adults
- Comparison
- Bexagliflozin 20 mg vs titrated glimepiride, as adjunct to metformin
- Primary endpoint
- Intergroup difference in change from baseline in percent HbA1c
- Follow-up
- Week 60
Methodological detailsdouble-blind, noninferiority
- Double-blind
- Noninferiority
Primary result
Change in HbA1c · baseline to Week 60
Intergroup difference
−0.55 mmol/mol
95% CI −2.30 to 1.20
Bexagliflozinvs Glimepiride
intergroup difference −0.55 mmol/mol (95% CI −2.30 to 1.20)
As reported in the abstract
Secondary outcomes
| Outcome | Difference (kg) (95% CI) | P value | |
|---|---|---|---|
| Change from baseline in body massPrespecified test | −4.31 (−5.10 to −3.52) | P < 0.0001 | |
| −10−505Difference, kg (linear scale) |
| Outcome | Difference (mm Hg) (95% CI) | P value | |
|---|---|---|---|
| Change from baseline in SBPPrespecified test | −6.53 (−10.56 to −2.51) | P = 0.0008 | |
| −15−10−505Difference, mm Hg (linear scale) |
Estimated glomerular filtration rate (eGFR) · follow-up visit
- Mean difference in eGFR between arms
- 6.05 mL min-1 per 1.73 m² (95% CI, 3.24, 8.87; P < 0.0001)
Safety
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| Severe or documented symptomatic hypoglycaemiaPrespecified test | 0.12 (0.05–0.28) | P < 0.0001 | |
| 0.050.21520Odds ratio (log scale) |
Original publication
A 96‐week, double‐blind, randomized controlled trial comparing bexagliflozin to glimepiride as an adjunct to metformin for the treatment of type 2 diabetes in adults. Diabetes Obes Metab. Published 23 October 2022. doi:10. 1111/ dom. 14875
Composed by AI from the published abstract and checked against it. How Briefs are made →