A Multicentre, Randomised, Controlled, Open‐Label Study of Continuous Subcutaneous Insulin Infusion Plus Henagliflozin for Treating Type 2 Diabetes Mellitus Patients With Severe Hyperglycaemia
Authors' conclusion
Henagliflozin + CSII achieved better glycaemic control, reduced insulin dosages and had a comparable safety profile versus CSII alone in severely hyperglycaemic T2DM patients.
Study context
- Population
- Adults with T2DM diagnosed within the past 2 years, with severe hyperglycaemiarandomised 1:1
- Participants
- 210 adults
- Comparison
- Henagliflozin + continuous subcutaneous insulin infusion (CSII) vs CSII alone
- Primary endpoint
- TIR (%) of 3.9-10.0 mmol/L blood glucose
Methodological detailsmulticentre, open-label, parallel-group, 7-day
- Multicentre
- Open-label
- Parallel-group
- 7-day
Primary result
As reported in the abstract
TIR
P = 0.005
Secondary outcomes
Time to achieve target glucose level (TIR > 70%)
- Shorter with henagliflozin+CSII than CSII
Time above range (TAR), insulin dosage, mean glucose and glucose management indicator (GMI)
- Significantly lower with henagliflozin+CSII than CSII
Time below range (TBR), mean amplitude of glycaemic excursions (MAGE), coefficient of variation (CV) and mean of daily differences (MODD)
- Not significantly different between the two groups
Safety
Adverse events (urinary tract infection, DKA, hypoglycaemic events)
- Did not differ between the two groups
Original publication
A Multicentre, Randomised, Controlled, Open‐Label Study of Continuous Subcutaneous Insulin Infusion Plus Henagliflozin for Treating Type 2 Diabetes Mellitus Patients With Severe Hyperglycaemia. Diabetes Obes Metab. Published 19 March 2026. doi:10.
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