Efficacy and safety of empagliflozin in combination with insulin in Chinese patients with type 2 diabetes and insufficient glycaemic control: A phase III , randomized, double‐blind, placebo‐controlled, parallel study
Authors' conclusion
In Chinese patients with T2D, empagliflozin combined with insulin ± OADs improved glycaemic control and was well tolerated, without an increased risk of hypoglycaemia.
Study context
- Population
- Chinese adults with T2D and insufficient glycaemic control on insulin ± up to two oral antidiabetic drugs (OADs)randomized 1:1:1
- Participants
- 219 adults
- Comparison
- Empagliflozin 10 or 25 mg vs placebo, added to insulin ± up to two OADs
- Empagliflozin 10 mgn = 73
- Empagliflozin 25 mgn = 73
- Placebon = 73reference
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, parallel group, multicentre, phase III
- Double-blind
- Placebo-controlled
- Parallel group
- Multicentre
- Phase III
Primary result
As reported in the abstract
Adjusted mean treatment difference
−0.99
P < 0.0001
Empagliflozin 10 mg
Adjusted mean treatment difference
−0.98
P < 0.0001
Empagliflozin 25 mg
Further findings
Change from baseline in FPG, 2-hour postprandial glucose and body weight
- Significantly larger decreases with both empagliflozin doses vs placebo
Safety
Confirmed hypoglycaemic events — Empagliflozin 10 mg vs Placebo
nominal P = .2422
| Outcome | P value |
|---|---|
| Confirmed hypoglycaemic eventsEmpagliflozin 25 mg vs Placebo | nominal P = .7661 |
Clinical Events Committee-confirmed DKA
- No CEC-confirmed DKA events reported
Original publication
Efficacy and safety of empagliflozin in combination with insulin in Chinese patients with type 2 diabetes and insufficient glycaemic control: A phase III , randomized, double‐blind, placebo‐controlled, parallel study. Diabetes Obes Metab. Published 23 March 2023. doi:10.
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