Date: 2015-06-04
Type of
information: Results
phase: 2
Announcement: results
Company: Poxel (France)
Product: imeglimin
Action
mechanism:
- glimin. Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the glimins. Imeglimin acts on three main target organs involved in glucose homeostasis: the liver, the muscle, and the pancreas and has therefore a distinct mode of action compared to existing treatments for Type 2 diabetes. Imeglimin has shown a significant anti-diabetic efficacy combined with an excellent tolerance in earlier monotherapy clinical trials.
Disease: type 2 diabetes
Therapeutic
area: Metabolic diseases
Country:
Trial
details:
Latest
news:
- • On June 4, 2015, Poxel, a biopharmaceutical company developing innovative drugs to treat type 2 diabetes, announced positive results from a new Phase 2 trial evaluating imeglimin. The results demonstrate that Imeglimin met the primary and secondary endpoints with statistical significance, while confirming safety and efficacy. This Phase 2 trial was an 18-week, randomized, placebo controlled trial in 59 subjects that were treated with either 1500mg of Imeglimin twice daily or placebo.
- In this trial, Imeglimin improves both fasting and post-prandial glucose control by increasing glucose-dependent insulin secretion and by improving insulin action. This unique profile translates into a significant HbA1c (glucose control) reduction of 0.62% (p=0.013) versus placebo,confirming Phase 2b and add-on therapy trial results. A significant effect on post-prandial glucose (reduction of 804 mmol.h/L, p=0.001) and on fasting plasma glucose was shown after treatment with Imeglimin (reduction of 1.22mmol/L, p=0.022). Imeglimin was also able to significantly increase insulin secretion and insulin sensitivity indexes in response to glucose during a challenge test.
- Consistent with the previously released Phase 2b results, as well as results from earlier trials evaluating Imeglimin as an add-on therapy to metformin or sitagliptin, Imeglimin demonstrated in this Phase 2 trial a favorable safety and tolerability profile with less subjects presenting one or more adverse events (AE) when treated with Imeglimin compared to placebo (27% versus 59%). Only one treatment-related AE (hyperglycemia) was described for the Imeglimin group, versus five in the placebo group. No drug-related serious AEs, hypoglycemia, or gastrointestinal events occurred in the Imeglimin group and no subject discontinued the trial for safety reasons.
Is
general: Yes
