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vTv Therapeutics Announces Completion of Phase 1b Study Evaluating TTP399 for the Treatment of Type 1 Diabetes
Simplici-T1 is an adaptive Phase 1b/2 study being conducted with support from JDRF
The Phase 1b assessment was an open label dose-escalation study in five patients with T1D, designed to determine the tolerability of TTP399 when added to insulin and the appropriate dosing range to be used in Phase 2 of the study. Results showed that TTP399 was found to be well-tolerated and improved or maintained glycemic control while reducing or simplifying an insulin regimen. In a six-month Phase 2b clinical trial of TTP399 in patients with type 2 diabetes, TTP399 demonstrated a statistically significant reduction in HbA1c levels in all TTP399 dose groups compared with placebo. TTP399 was also found to be well-tolerated without increased incidences of hypoglycemia and hyperlipidemia compared to placebo.
“There is a tremendous need for new, safe and effective treatment
options for the millions of people living with T1D,” said Dr.
The glucokinase enzyme (GK) is a key regulator of glucose metabolism, and its activation has been shown to increase glucose utilization, which in turn lowers blood glucose. TTP399 is an orally available GK activator that is designed for superior glucose control by targeting GK activation only in the liver. TTP399 exhibits an insulin-independent mechanism of action which may be suitable as an adjunctive treatment for T1D.
“We are pleased that TTP399 continues to show favorable tolerability and
hope that further exploration of the therapy in T1D will produce the
same positive effects that were evident in previous type 2 diabetes
clinical studies,” said
Simplici-T1 is a multi-center, randomized, double-blind, adaptive study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of TTP399 in adult patients with type 1 diabetes (T1D). This study is being conducted in two phases: Phase 1 evaluated the safety of ascending TTP399 dosage regimens each over one week of daily dosing; Phase 2 will evaluate the safety and efficacy of a TTP399 dosing regimen over twelve weeks of daily dosing.
About Type 1 Diabetes
Type 1 diabetes (T1D) is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. Its onset has nothing to do with diet or lifestyle. There is nothing you can do to prevent T1D, and—at present—nothing you can do to cure it.
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