Drug to prevent night lows approved for trial

America’s Food and Drugs Administration (FDA) recently cleared for a phase 2 clinical trial a new drug for Type 1 diabetes which would be the first therapy to specifically address low blood glucose at night.

Diabetes-focused life sciences company Zucara Therapeutics claim that the drug, an injectible medication currently known as ZT-01, attempts to restore the body’s natural ability to respond to low blood sugar levels. ZT-01 is a first-in-class somatostatin receptor 2 antagonist – somatostatin is a hormone made by the pancreas that prevents the body from releasing glucagon.

Glucagon counteracts insulin and raises glucose levels, and having Type 1 diabetes may affect the body’s ability to release glucagon during a low; the goal of ZT-01 is to restore the body’s glucagon response, which could make it easier to recover from lows.

The planned clinical trial will evaluate the ability of the drug to blunt hypoglycemia caused by insulin in Type 1 diabetes and will primarily look at rates of overnight hypoglycemia, as measured by a continuous glucose monitor, while participants take the drug every evening before bed for four weeks.

This trial follows positive results from the company’s earlier phase 1 study which included 18 participants with Type 1 diabetes: of these, 16 (89%) had a meaningful increase in glucagon production after being given ZT-01, with no serious health events during the trial.

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