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In health, postprandial glucose elevation triggers pancreatic beta-cell insulin secretion in a biphasic pattern, facilitating glucose uptake in skeletal muscle, adipose tissue, and hepatic suppression of gluconeogenesis

Salisbury, B., Leslie, S., & Tadi, P

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"We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data." FDA noted that two of the nine randomized subjects who received the investigational product were not eligible under the enrollment criteria