Efficacy and safety of the sodium‐glucose co‐transporter‐2 inhibitor empagliflozin in elderly Japanese adults (≥65 years) with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, 52‐week clinical trial ( EMPA‐ELDERLY )
Primary result · Change from baseline in HbA1cResult — go to the resultPlacebo-adjusted mean change −0.57 % 95% CI −0.78 to −0.36Authors' conclusion
Empagliflozin improved glucose control and reduced body weight without compromising muscle mass or strength in elderly adults with T2D in this trial.
Study context
- Population
- Elderly Japanese adults with T2D aged ≥65 years, BMI ≥22 kg/m², HbA1c 7.0%-10.0%; 72.4% men, mean age 74.1 yearsrandomized 1:1
- Participants
- 129 adults
- Comparison
- Empagliflozin 10 mg once daily vs placebo
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- Week 52
Methodological detailsdouble-blind, placebo-controlled, 52-week
- Double-blind
- Placebo-controlled
- 52-week
Primary result
As reported in the abstract
Placebo-adjusted mean change
−0.57 %
95% CI −0.78 to −0.36
Empagliflozinvs Placebo
placebo-adjusted mean change −0.57 % (95% CI −0.78 to −0.36)
Secondary outcomes
kg
| Outcome | Empagliflozin | Placebo | Estimate | |
|---|---|---|---|---|
| Change in body weight | −3.26 | −0.90 | placebo-adjusted difference −2.37 kg (95% CI −3.07 to −1.68) | |
| Change in muscle mass | placebo-adjusted change −0.61 kg (95% CI −1.61 to 0.39) | |||
| Change in fat mass | placebo-adjusted change −1.84 kg (95% CI −2.65 to −1.04) | |||
| Change in grip strength | placebo-adjusted change −0.3 kg (95% CI −1.1 to 0.5) | |||
| −4−202Difference, kg (linear scale) |
Original publication
Efficacy and safety of the sodium‐glucose co‐transporter‐2 inhibitor empagliflozin in elderly Japanese adults (≥65 years) with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, 52‐week clinical trial ( EMPA‐ELDERLY ). Diabetes Obes Metab. Published 25 August 2023. doi:10. 1111/ dom. 15249
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