Introduction and Objectives: Metformin is the first line drug recommended for management of T2DM. Intolerable GI side effects of metformin leads to its discontinuation in 15-20% of patients leading to miss out of its multiple benefits. Imeglimin shares the insulin sensitizing MOA similar to metformin with and additional effect on insulin secretion without untoward side effects of metformin. Objective of this study was to observe efficacy and safety of Imeglimin in metformin intolerant participants.
Methods: Fifty-three subjects above their glycemic targets, on OHAs without metformin due to its intolerance were enrolled for this study. It was a prospective observational study. Imeglimin in a dose of 1 gm BD/day started in all participants for the 24 weeks without changing the existing regimen. HbA1c & weight was observed before and after the completion of study duration. Participants were asked to visit every week during observation period and sos if any side effects appeared.
Results: All participants completed the observation period. Male: female = 1:0.7, Average age was 46.7±7 years, Duration of diabetes was 4.1±3.1 years. Average HbA1c at start was 8.3±0.5 whereas after 24 weeks was 7.3±0.5 (The t-value is 9.95663. The p-value is < .00001. The result is significant at p < .05.). Average weight at start was 69±12.4 Kg whereas at completion was 69.5±12.5 Kg (The t-value is -0.21796. The p-value is .413944. The result is not significant at p < .05). Three out of 7 whereas 1 out of 10 subjects with BMI above and less than 28 respectively, observed weight reduction of >10% (The chi-square statistic is 1.4852. The p-value is .222969. The result is not significant at p < .05.) Side effects observed were: withdrawn Imeglimin 1 (1.8%), Bloating: 5, increased Stool frequency: 3, Burning abdomen: 1.
Conclusion: Imeglimin show better GI tolerability as compared to metformin and significant Hba1c reduction with no effects on weight.
P.K. Agrawal: None. A. Gautam: None. N. Pursnani: None. A. Yadav: None.
