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Henagliflozin monotherapy in patients with type 2 diabetes inadequately controlled on diet and exercise: A
Juming Lu1, Liujun Fu2, Yan Li3
1Department of Endocrinology, Chinese PLA General Hospital, Beijing, China.
Aim:
To evaluate henagliflozin, a novel sodium-glucose co-transporter-2 inhibitor, as monotherapy in patients with type 2 diabetes and inadequate glycaemic control with diet and exercise.
Materials And Methods:
This multicentre trial included a 24-week, randomized, double-blind, placebo-controlled period, followed by a 28-week extension period. Four hundred and sixty-eight patients with an HbA1c of 7.0%-10.5% were randomly assigned (1:1:1) to receive once-daily placebo, or 5 or 10 mg henagliflozin. After 24 weeks, patients on placebo were switched to 5 or 10 mg henagliflozin, and patients on henagliflozin maintained the initial therapy. The primary endpoint was the change in HbA1c from baseline after 24 weeks.
Results:
At Week 24, the placebo-adjusted least squares (LS) mean changes from baseline in HbA1c were -0.91% (95% CI: -1.11% to -0.72%; P < .001) and -0.94% (-1.13% to -0.75%; P < .001) with henagliflozin 5 and 10 mg, respectively; the placebo-adjusted LS mean changes were -1.3 (-1.8 to -0.9) and -1.5 (-2.0 to -1.1) kg in body weight, and -5.1 (-7.2 to -3.0) and -4.4 (-6.5 to -2.3) mmHg in systolic blood pressure (all P < .05). The trends of these improvements were sustained for an additional 28 weeks. Adverse events occurred in 81.0%, 78.9% and 78.9% of patients in the placebo, henagliflozin 5 and 10 mg groups, respectively. No diabetic ketoacidosis or major episodes of hypoglycaemia occurred.
Conclusions:
Henagliflozin 5 mg and 10 mg as monotherapy provided effective glycaemic control, reduced body weight and blood pressure, and was generally well tolerated.
Insights
Henagliflozin effectively lowered blood sugar, body weight, and blood pressure in type 2 diabetes patients. This novel sodium-glucose co-transporter-2 inhibitor demonstrated good tolerability and sustained benefits over 52 weeks.
Area of Science:
- Endocrinology
- Pharmacology
- Metabolic Diseases
Background:
- Type 2 diabetes mellitus (T2DM) affects millions globally, necessitating novel therapeutic strategies.
- Inadequate glycemic control remains a significant challenge, often requiring combination therapies.
- Diet and exercise alone are frequently insufficient for achieving target glycemic control in T2DM.
Purpose of the Study:
- To evaluate the efficacy and safety of henagliflozin as monotherapy in T2DM patients.
- To assess the impact of henagliflozin on glycemic control, body weight, and blood pressure.
- To determine the long-term effects of henagliflozin over a 52-week treatment period.
Main Methods:
- A 24-week, randomized, double-blind, placebo-controlled trial involving 468 T2DM patients with HbA1c between 7.0% and 10.5%.
- Patients received once-daily placebo, 5 mg henagliflozin, or 10 mg henagliflozin.
- A subsequent 28-week extension period allowed for continued treatment or switch to active therapy.
Main Results:
- Henagliflozin (5 and 10 mg) significantly reduced HbA1c by -0.91% and -0.94% respectively, compared to placebo (P < .001).
- Significant reductions in body weight (-1.3 to -1.5 kg) and systolic blood pressure (-4.4 to -5.1 mmHg) were observed.
- These improvements were sustained throughout the 52-week study duration with no major safety concerns like diabetic ketoacidosis or hypoglycemia.
Conclusions:
- Henagliflozin monotherapy offers effective glycemic control in T2DM patients.
- The drug also provides beneficial effects on body weight and blood pressure.
- Henagliflozin is generally well-tolerated, supporting its use as a treatment option.
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