Evaluating henagliflozin in patients with type 2 diabetes

This study tested the ability of henagliflozin (SHR3824) in controlling blood glucose levels in patients with type 2 diabetes (T2D). The authors found that henagliflozin alone was able to control glucose levels, reduce body weight and blood pressure in these patients.

Insulin is a hormone produced by the pancreas to deliver sugar (glucose) from the blood into the cells. In T2D, insulin is not able to bring glucose into the cells, resulting in increased blood glucose levels. Metformin (Glucophage) is commonly the first drug used in T2D. Metformin works by reducing the amount of glucose released by the liver. In addition, it helps the body to respond better to insulin.

However, metformin cannot be used by all patients with type II diabetes, because it can cause gastrointestinal effects like diarrhea and stomach ache. Sodium-glucose co-transporter-2 (SGLT2) inhibitors are a new class of antidiabetic drugs able to control glucose levels. SGLT2 inhibitors help excess blood glucose to be eliminated from the body through the kidney into the urine. They also seem to reduce body weight and blood pressure through diuresis.

Henagliflozin is a new SGLT2 inhibitor under development that can be taken orally. Its effectiveness and safety as single therapy in patients with T2D is not known.

This study enrolled 458 patients with T2D that was not controlled with diet and exercise alone. They were divided into 3 groups. Group 1 included 153 patients treated with a placebo. Group 2 was given 5mg henagliflozin. Group 3 was given 10mg henagliflozin. Treatments were given for 24 weeks once a day in the morning. After this period, patients in group 1 were switched to henagliflozin 5 or 10mg for 28 weeks, while patients in groups 2 and 3 kept their initial treatment. The HbA1c level was evaluated as a measure of blood glucose control.

After 24 weeks, groups 2 and 3 had a significant reduction of HbA1c levels compared to group 1 (by 0.91% and 0.94%). 20.8% more patients in group 2 and 22.5% more patients in group 3 achieved HbA1c levels below 7% compared to group 1. 

Henagliflozin in both doses also reduced body weight and blood pressure levels compared to placebo after 24 weeks. These benefits were maintained for all duration of the study. Also, patients who switched from placebo to henagliflozin saw the same reductions in blood glucose, weight and blood pressure as patients in groups 2 and 3. 

Henagliflozin was safe and well tolerated by patients. 3.9% of patients in groups 2 and 3 and 6.5% of group 1 experienced serious side effects. 

The authors found that henagliflozin may reduce glucose blood levels, body weight, and blood pressure in patients with T2D.

This study had a short follow-up period. Also, it only included Chinese patients. More studies are needed to evaluate this drug in other populations. This study was funded by Jiangsu Hengrui Medicine Co.Ltd, the manufacturer of henagliflozin.