New diabetes monotherapy shows promise
MedWire News: Imeglimin appears to be a well-tolerated and effective monotherapy for Type 2 diabetes, report researchers.
"It combines a safety/tolerability profile that is comparable with placebo, with a benefit in glycemic control that is similar to metformin," say Pascale Fouqueray (Pauls Stradins Clinical University Hospital, Riga, Latvia) and colleagues.
The findings come from two randomized, double-blind trials which tested the safety and efficacy of the new oral antidiabetes agent, and compared it with profiles for placebo and metformin.
During a 4-week study, 58 Type 2 diabetes patients who were either treatment-naïve or on monotherapy (sulfonylurea or metformin) were randomly allocated to receive imeglimin 2000 mg once daily, imeglimin 1000 mg twice daily, or metformin 850 mg twice daily. The patients underwent an oral glucose tolerance test (OGTT) at the end of the treatment period.
In an 8-week study, 118 similar patients were randomly allocated to receive imeglimin 500 mg twice daily, imeglimin 1500 mg twice daily, metformin 850 mg twice daily, or placebo. The patients underwent a 6-hour meal test and other glycemic assessments at the end of the intervention.
As reported in the Journal of Diabetes Investigation, imeglimin 1000 mg twice daily was as effective as metformin 850 mg twice daily at decreasing the areas under the plasma glucose curves in the OGTT, with respective reductions of 33% and 30%. Imeglimin once daily, on the other hand, had a significantly smaller effect than metformin.
In addition, imeglimin 1500 mg twice daily was just as effective as metformin 850 mg twice daily at reducing fasting plasma glucose, glycated hemoglobin, and the area under the curve for glucose during the 6-hour meal test. Imeglimin 1500 mg twice daily was significantly more effective at reducing these parameters than imeglimin 500 mg twice daily.
Furthermore, the researchers found that imeglimin exhibited a more favorable tolerability profile than metformin.
During the 8-week study, treatment-emergent adverse events (TEAEs) were experienced by three (10%), three (9%), and seven (21%) individuals in the imeglimin 500-mg, placebo, and metformin groups, respectively, whereas no individuals in the imeglimin 1500-mg group had TEAEs.
Three (9%) patients in the metformin group reported gastrointestinal-related adverse events including diarrhea, gastro-esophageal reflux disease, and vomiting. By contrast, no serious or severe adverse events were associated with imeglimin.
"This safety profile may offer opportunities for combination with existing medications and increase treatment options for a wide range of populations, including sensitive populations," say Fouqueray and team.
"The effects of imeglimin on glycemic control as well as its good safety and tolerability profile indicate that it has the potential to be a new tool to manage Type 2 diabetes," they conclude.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012
By Sally Robertson