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Posted by on May 9, 2021 in Diabetes mellitus | 0 comments

In a nutshell

This study examined the effectiveness of adding henagliflozin (SHR3824) to metformin (Glucophage) in patients with uncontrolled type 2 diabetes (T2D). The authors concluded that the addition of 5 mg or 10 mg of henagliflozin to metformin was well-tolerated and effective in these patients. 

Some background

The initial management approach for T2D is diet, exercise, and metformin treatment. Effective management means achieving HbA1c levels (blood glucose control for 2-3 months below 7%. Add-on therapy to metformin may be required for patients who do not achieve target HbA1c levels.

Sodium-glucose cotransporter type 2 inhibitors (SGLT2i) are glucose-lowering drugs that remove excess glucose through urine. Henagliflozin is an oral SGLT2i that has shown good effectiveness and safety when used alone in patients with T2D. However, the effectiveness and safety of adding henagliflozin to metformin treatment in patients with inadequately controlled T2D are unknown.

Methods & findings

495 patients with poorly controlled T2D with metformin treatment were included in this study. They were randomly assigned to 1 of 3 groups. Group 1 received a placebo, group 2 received henagliflozin 5 mg, and group 3 received henagliflozin 10 mg for 24 weeks. After this, patients in the placebo group received henagliflozin 5 or 10 mg for another 28 weeks. During the study, all patients continued to receive metformin treatment.

After 24 weeks, patients in group 2 had a reduction of 0.76% in HbA1c levels compared to group 1. Patients in group 3 had a reduction in of 0.8% HbA1c levels compared to group 1. Significantly more patients in group 2 (32.1%) and 3 (32.5%) achieved an HbA1c level below 7% after 24 weeks compared to group 1 (11.2%).

Both henagliflozin doses reduced plasma glucose, body weight and blood pressure compared to placebo. Patients who switched from placebo to henagliflozin achieved similar reductions in HbA1c levels, body weight, and blood pressure as did those who received henagliflozin at the beginning of the study.

Serious side effects were reported in 4.3% of patients in group 1, 7.9% in group 2, and 3.1% in group 1. These included urinary infection, very low blood glucose levels, and high blood fat levels.

The bottom line

The study concluded that henagliflozin add-on therapy to metformin in patients with inadequately controlled T2D was generally well-tolerated and improved blood glucose control, body weight, and blood pressure.

The fine print

Longer durations and comparative studies are needed. The study was based on patients from China and does not necessarily reflect the global population.

Published By :

Diabetes, Obesity and Metabolism

Date :

Mar 26, 2021

Original Title :

Henagliflozin as add-on therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial.

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