JDC Gems

6. Drug/Device Updates

(i) Imeglimin: A new 2 diabetes

      A systematic review and meta-analysis published in the British Journal of Diabetes observed valuable and reliable data for a new drug candidate Imeglimin, as an effective medication for the treatment of diabetes with a novel mechanism of action.

    Imeglimin belongs to a class of glucose-lowering agents called "glimins." In researcher's point of view, mitochondrial dysfunction is a characteristic defect in individuals with T2D, as well as those with obesity. Studies in animal models had showed that the drug targets mitochondrial dysfunction and its likely mechanism of action is via a mitochondrial mechanism to increase glucose uptake by skeletal muscle, decrease hepatic glucose output, and increase glucose-dependent insulin secretion. Imeglimin improves mitochondrial function by reducing the overproduction of reactive oxygen species, protecting mitochondria from excessive oxidative stress. The drug also increases the master regulator of mitochondrial biogenesis, peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) and increases the number of mitochondria. In short, the improvement in mitochondrial function associated with Imeglimin may increase muscle insulin sensitivity and insulin secretion while reducing hepatic glucose production. It may also protect endothelial cells from damage caused by glucotoxicity and have beneficial cardiovascular effects.

      A total of 17 phase 1 clinical trials and 8 phase 2 clinical trials have been completed for this drug. According to results from a phase 2 clinical trial using Imeglimin as an add-on to metformin, imeglimin demonstrated a significantly greater reduction in glycated hemoglobin compared with placebo during a 12-week period (-0.65% vs -0.21%; P <.001). Imeglimin also demonstrated good safety and tolerability up to 6000 mg, with the highest dose (8000 mg) inducing mild gastrointestinal effects.

This drug is currently in phase 3 trials of human studies and is likely to continue in the approval process based on currently available data.

(ii) FDA approval for FreeStyle Libre 2 for adults & children with diabetes

      FDA had approved the next generation integrated continuous glucose monitoring system (iCGM) for adults, children of 4 years and older adults with diabetes. The Freestyle Libre 2 iCGM system is the only system with optional real-time alarms that measures the glucose levels every minute. The system has a 14-day wear time making it the longest-lasting, self-applied iCGM available.

      Using Bluetooth technology, the FreeStyle Libre 2 system automatically alerts users when their glucose is high or low without needing to scan the sensor. Users also have the option of turning off the customisable, real-time alarms. The system has a combined mean absolute relative difference (MARD), a measurement of performance for CGMs, of 9.3 per cent (9.2 per cent for adults and 9.7 per cent for paediatrics), making it the only iCGM sensor sustaining a high level of accuracy over 14 days. With a one-second scan using a handheld reader, users can view their glucose reading, trend arrow and eight-hour history.

With the add-on features this next-generation CGM system can be significant in serving the diabetes community effectively in the diabetes care, management, education and improving the quality of life.

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