Is PEX168 alone effective in improving blood glucose control in patients with type 2 diabetes?

Posted by Medivizor on Jan 10, 2021 in Diabetes mellitus |

In a nutshell

This study looked at the effect of treatment with polyethylene glycol loxenatide (PEX168) alone in patients with poorly controlled type 2 diabetes (T2D). They found that PEX168 significantly improved blood glucose control in these patients.

Some background

Blood glucose is controlled by many hormones. The most important ones are insulin and glucagon produced by the pancreas. There are also gut hormones such as GLP-1 that regulate the amount of insulin or glucagon secreted by the pancreas. Newer diabetes medications aim to imitate these hormones. 
PEX168 is a GLP-1 analogue that works by increasing the amount of natural insulin secreted by the body. It is given by weekly injection, which may be more convenient for patients than daily treatment.  A previous short-term study showed promising effectiveness of PEX168 for patients with T2D. However, its long-term effectiveness and safety are still not clear.

Methods & findings

361 patients with poorly controlled T2D were included in this study. They were divided into 3 groups. Group 1 (121 patients) received a placebo, group 2 (124 patients) received low-dose (100 μg) PEX168 and group 3 (116 patients) received high-dose (200 μg) PEX168. Patients were monitored for 24 weeks. After this period, patients in group 1 were randomly assigned to group 2 or 3 for another 28 weeks. The main outcome evaluated was a change in HbA1c levels, which is a measure of blood glucose control over the past 2-3 months.
After 24 weeks, the was a significantly higher reduction in HbA1c levels in groups 2 (by 1.02%) and 3 (by 1.34%) than in group 1 (by 0.17%) compared to the beginning of the study. This reduction was consistent also after 1 year of treatment.
Significantly more patients in group 2 (34.7%) and group 3 (46.6%) achieved an HbA1c level lower than 7% after 24 weeks compared to group 1 (15.7%). After 52 weeks, 37.2% of group 1 who switched to group 2 and 42.7% of those in group 1 who switched to group 3 achieved HbA1c levels below 7%.
Overall, the proportions of patients who reported side effects were similar between the 3 groups. The most common side effect of PEX168 was nausea, which affected 10% of group 3 and 5.6% of group 2.

The bottom line

This study showed that treatment with PEX168 alone improves diabetic control in patients with poorly-controlled T2D.

The fine print

6 months is a relatively short follow-up time for T2D. Longer studies are needed to confirm these results. Also, this study excluded patients with serious complications of diabetes. More studies are needed to see how these patients react to treatment. This study was funded by Hansoh Pharma, the manufacturer of PEX168.

Published By :
Diabetes, Obesity and Metabolism

Original Title :
Efficacy and safety of polyethylene glycol loxenatide (PEX168) monotherapy in type 2 diabetes patients: a multicenter, randomized, double-blind, placebo-controlled, phase 3a clinical trial.

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