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Unacceptable hyperglycemia was determined when any of the fasting plasma glucose (FPG) levels measured at scheduled visits and a confirmatory FPG obtained by the local or central laboratory exceeded the following limits and no inter-current cause of the hyperglycemia could be identified: 15 mmol/L from baseline to week 6 (or to week 7 in SUSTAIN-7) 13.3 mmol/L from week 6 to week 12 (or from week 8 to week 13 in SUSTAIN-7) 11.1 mmol/L from week 12 (or from week 14 in SUSTAIN-7) to end-of-trial Rescue medication referred to intensification of the existing background medication or initiation of new medication, and it was prescribed as add-on to randomized treatment

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Fleur's concept addresses the limitations of current therapies through a biomimetic strategy that leverages the body's natural GLP-1 production mechanisms: Utilize a probiotic oral delivery system to populate the gut microbiome long-term with natural (short-lasting) GLP-1 producing bacteria