Treatment of type 2 diabetes often begins with lifestyle management and/or metformin. As beta-cell function declines in the presence of insulin resistance, this makes maintenance of glycemic control challenging and usually necessitates add-on therapies.
In a recent study, researchers have reported that Henagliflozin, a sodium-glucose cotransporter 2 (SGLT2) as add‐on therapy to metformin effectively achieve glycemic control in patients with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. The research has been published in the journal DIABETES, OBESITY AND METABOLISM on March 26, 2021.
Inhibition of sodium-glucose cotransporter 2 (SGLT2) represents a novel approach to reduce hyperglycemia independently of insulin secretion or action. Henegliflozin is a novel SGLPT2 inhibitor and has been shown to improve glycemic control in patients with type 2 diabetes. However, its combination effect with metformin is understudied. Therefore, Dr Jianping Weng and his team conducted a study to evaluate the efficacy and safety of henagliflozin in patients with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
It was a multicenter, 24 weeks randomized, double‐blind, placebo‐controlled, phase 3 trial, followed by a 28‐week extension period. A total of 483 patients with a hemoglobin A1c (HbA1c) of 7.0%‐10.5% were randomly assigned to receive once‐daily Placebo (n=161), Henagliflozin 5 mg (n=162), or Henagliflozin 10 mg (n=160). After 24 weeks, the researchers switched the patients on placebo to 5 or 10 mg henagliflozin for the additional 28‐week treatment, and patients on henagliflozin during the 24‐week treatment period maintained the initial therapy. The major outcome assessed was a change in HbA1c from baseline to Week 24.
Key findings of the study were:
After 24 weeks, the researchers noted that the least‐squares mean HbA1c changes versus placebo from baseline were ‐0.76% and ‐0.80% for henagliflozin 5 mg and 10 mg.
They noted that compared with the placebo group, both doses of henagliflozin lowered fasting plasma glucose, 2‐hour postprandial plasma glucose, body weight, blood pressure and increased the proportions of patients achieving HbA1c <7.0% at Week 24.
They also noted that these improvements were sustained over additional 28 weeks.
They observed slightly higher proportions of ketosis, urine ketone body present in patients treated with henagliflozin compared to placebo at Week 24.
However, they reported no diabetic ketoacidosis or episode of severe hypoglycemia.
The authors concluded, "Henagliflozin 5 or 10 mg as add‐on therapy to metformin provided a new therapeutic option for treatment of T2DM patients who have inadequate glycemic control with metformin alone, and was generally well tolerated."
For further information:
https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14389