A Multicentre, Randomised, Controlled, Open-Label Study of Continuous Subcutaneous Insulin Infusion Plus Henagliflozin for Treating Type 2 Diabetes Mellitus Patients With Severe Hyperglycaemia.

TL;DR

In a 7-day trial of 210 people with newly diagnosed type 2 diabetes, adding the SGLT2 inhibitor henagliflozin to continuous subcutaneous insulin infusion (insulin pump therapy) improved time in target blood glucose range and reduced insulin requirements compared to insulin pump alone.

What the study found

Researchers at multiple centers enrolled 210 adults with type 2 diabetes diagnosed within the previous 2 years who presented with severe hyperglycemia (very high blood sugar). Half received a combination of henagliflozin, an SGLT2 inhibitor not yet approved in major Western markets, plus continuous insulin infusion via pump. The other half received insulin pump therapy alone. The 7-day observation period was short, but measured multiple glycemic control markers continuously using glucose monitoring technology.

The combination approach produced measurable advantages in glucose control. Time in range (the percentage of time blood glucose stayed between 3.9 and 10.0 mmol/L) reached 79.85% in the henagliflozin plus insulin group versus 74.06% with insulin alone (p = 0.005). This 5.79 percentage point difference means the combination group spent roughly 1.4 more hours per day within target glucose levels. The combination group also reached the 70% time-in-range target faster than the insulin-only group. Mean glucose levels, daily glucose variability, and glucose management indicator scores all favored the combination approach.

An important clinical finding was reduced insulin requirement. Patients in the henagliflozin plus insulin group needed lower total daily insulin doses to achieve these better glucose outcomes. This matters because excessive insulin dosing can increase hypoglycemia risk and weight gain. However, the study found no significant difference in actual hypoglycemic events between groups, nor did serious adverse events like diabetic ketoacidosis differ between treatment arms. Urinary tract infections occurred in both groups at similar rates. Overall, the safety profile appeared comparable between approaches, though the 7-day timeframe limits conclusions about longer-term safety.

One notable gap: glycemic variability metrics (MAGE, coefficient of variation, and mean of daily differences) did not differ significantly between groups. This suggests both approaches achieved similar moment-to-moment glucose stability, with the main benefit being overall time spent in range rather than smoother glucose curves.

What this means for you

This trial specifically examined people with newly diagnosed type 2 diabetes and severe hyperglycemia, so findings apply most directly to that population. The 7-day observation window is quite short for evaluating chronic disease management; longer-term studies would better inform clinical decision-making about combination therapy.

For individuals newly diagnosed with type 2 diabetes requiring insulin pump therapy, adding an SGLT2 inhibitor like henagliflozin showed potential to improve glucose control while reducing insulin doses. This could be particularly relevant if you're in a healthcare system where henagliflozin is available (it's approved in some Asian markets but not yet in the US or EU). The mechanism appears sound: SGLT2 inhibitors lower renal glucose reabsorption threshold, increasing urinary glucose excretion, while insulin pumps deliver precise insulin dosing. Together they complement each other.

That said, the study was open-label, meaning both patients and providers knew who received which treatment, which can introduce bias in measurement or reporting. A placebo-controlled design would strengthen confidence in the results. Additionally, this was a single-center study published in a general diabetes journal; replication across diverse populations would help establish whether benefits hold across different genetic backgrounds and healthcare settings.

The practical takeaway is moderate and evidence-based: in newly diagnosed type 2 diabetes with severe hyperglycemia managed via insulin pump, combination therapy with an SGLT2 inhibitor appears to improve glucose control metrics and reduce insulin requirements without apparent safety concerns in a short-term window.

Study details

Sources

Henagliflozin Combined With Continuous Subcutaneous Insulin Infusion for Type 2 Diabetes With Severe Hyperglycemia. PubMed: https://pubmed.ncbi.nlm.nih.gov/41853855/