Evaluating the safety and effectiveness of polyethylene glycol loxenatide in patients with T2D

This study examined the effectiveness and risks of polyethylene glycol loxenatide (PEX168) as an add-on to metformin (Glucophage) therapy in patients with type 2 diabetes (T2D).

It found that PEX168 is safe and works effectively in improving the blood sugar levels in these patients.

T2D is a chronic condition where the processing of glucose (sugar) as a main source of energy is impacted. With T2D the function of the hormone insulin is disturbed. Insulin is needed to lower glucose levels in the blood by transporting glucose from the blood to the cells. Stable glucose levels in the blood are essential for a healthy body function. The indicator of blood glucose control is the HbA1c with a goal level of 6.5%.

Besides a healthy lifestyle, there are many drugs used to manage T2D. Metformin is commonly the standard first treatment for T2D. Another option are glucagon-like peptide (GLP-1) receptor agonists (RA) which increase the amount of insulin in the body. 

PEX168 is a new long-acting GLP-1 RA being developed that has shown promise in small studies. It is administered as a subcutaneous (under the skin) injection once a week. However, its safety and effectiveness as an add-on to metformin treatment in patients with uncontrolled T2D remains under investigation.

For this study, 533 patients with uncontrolled T2D treated with metformin alone were included. Patients were randomly placed into one of three groups. All of the groups continued the metformin treatment during the study. Group 1 received an additional placebo. Group 2 received an additional 100 μg of PEX168, and group 3 an additional 200 μg of PEX168. Patients were treated for 24 weeks and monitored for an overall period of 52 weeks. 

At 24 weeks there was a significant decrease in the HbA1c levels in both PEX168-groups compared to the placebo group. Significantly more patients in groups 2 (37.4%) and 3 (40.6%) achieved a HbA1c value lower than 7% at week 24 compared to group 1 (16.8%) in the placebo group reached this value. This decrease in HbA1c levels was maintained up to 52 weeks. Also, significantly more patients in group 2 (17.3%) and 3 (21.1%) achieved a HbA1c below 6.5% at 24 weeks compared to group 1 (6.1%).

The rate of side effects was similar in all 3 groups. The most common side effects were mild and included diarrhea, nausea, bloating and vomiting. 

This study concluded that PEX168 is a low-risk and effective treatment as an add-on to metformin treatment in patients with uncontrolled T2D.  

This study was funded by Hansoh Pharma, the manufacturer of PEX168. Also, this study included only Chinese participants. Therefore, the results may not apply to other populations.