Adding once-daily lixisenatide to basal insulin treatment is effective at improving glycemic control in Asian patients with Type 2 diabetes, show study findings.
Over a 24-week period, the drug significantly improved glycated hemoglobin (HbA1c) levels and enhanced postprandial glucose (PPG) control in patients with diabetes that was insufficiently controlled by their established insulin regimen (with or without a sulfonylurea).
"Incretin-based therapies seem to be particularly effective in Asian and Japanese diabetes patients… and there is some evidence to suggest a profound underlying GLP-1 insufficiency in these patients," note Yutaka Seino (Kansai Electric Power Hospital, Osaka, Japan) and colleagues.
However, "of the studies that have evaluated the efficacy and safety of GLP-1 receptor agonists in Japanese patients, only one GLP-1 study to date has included patients on insulin therapy and only 3% of the total population was Asian," they remark.
As reported in Diabetic Medicine, the team's randomized, double-blind, placebo-controlled study of 311 individuals showed that daily administration of add-on lixisenatide (20 µg) over a 24-week period reduced patients' mean HbA1c level by a significant 0.77% from baseline. By contrast, there was a 0.11% increase in mean HbA1c among placebo-treated patients.
Furthermore, a standardized meal test showed that lixisenatide had a pronounced effect on PPG control, significantly decreasing 2-hour PPG values and blood glucose excursions from baseline to week 24, compared with placebo.
"PPG makes a greater contribution to HbA1c as patients start to approach recommended HbA1c goals," explains the team. "At HbA1c <8.5%, FPG [fasting plasma glucose] makes the predominant contribution to overall glycemic control, whereas PPG becomes more relevant at lower HbA1c levels."
Overall, lixisenatide was generally well tolerated, say the authors. The incidence of treatment-emergent adverse events (mainly gastrointestinal and hypoglycemic events) was higher with lixisenatide versus placebo, but the events were mostly mild-to-moderate intensity and resolved spontaneously without sequalae.
"The results support those of other Phase III studies highlighting the potential of lixisenatide for further development as a glucose-lowering agent to treat Type 2 diabetes," concludes the team.
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