12.10.2021 14:29:30
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VTv: Study Result Shows TTP399 Lowers Blood Glucose Without Increasing Risk Of Diabetic Ketoacidosis
(RTTNews) - vTv Therapeutics Inc. (VTVT) announced positive results of a mechanistic study of TTP399 in patients with type 1 diabetes or T1D. The study demonstrated that patients with T1D taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating no increased risk of ketoacidosis.
The U.S. Food and Drug Administration declined to approve SGLT2 inhibitors as an adjunctive therapy in T1D, with concerns over the potential risks of diabetic ketoacidosis (DKA) in focus. DKA can lead to hospitalization and, if untreated, death.
In order to address the concerns, vTv, following the FDA's recommendation, conducted the mechanistic study to demonstrate that treatment with TTP399, a liver-selective glucokinase activator, will not result in increased production of ketones, a precursor to ketoacidosis.
The company noted that themechanistic study confirmed the hypothesis that treatment with TTP399 lowers glucose, results in less hypoglycemia, and does not increase the formation of ketone.
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