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vTv Therapeutics Announces Positive Results from Part 2 of the Phase 2 Simplici-T1 Study of TTP399, Potential First-in-Class Oral Adjunctive Therapy for Patients with Type 1 Diabetes
- TTP399, a novel glucokinase activator, achieves primary objective of a statistically significant reduction in HbA1c, without increases in hypoglycemia or
About this update from Vtv Therapeutics Inc.
[{"type":"text","content":"- TTP399, a novel glucokinase activator, achieves primary objective of a statistically significant reduction in HbA1c, without increases in hypoglycemia or ketoacidosis\n - Company to host investor conference call today at 8:30 a.m. ET HIGH POINT, N.C., Feb. 10, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) today announced positive results from Part 2 of the Phase 2 Simplici-T1 trial assessing TTP399 as an oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D). TTP399 is a novel, liver-selective glucokinase activator taken once a day. The 12-week trial investigated the efficacy and safety of 800 mg of TTP399 compared with placebo in 85 people with type 1 diabetes on optimized insulin therapy. The study was conducted with support from JDRF International (JDRF), the leading provider of T1D research funding globally. The trial successfully achieved its primary objective analyzed using two statistical approaches to evaluating the effect of TTP399. The primary statistical analysis evaluated the effect on HbA1c regardless of treatment adherence or notable changes in insulin administration. Under the primary statistical analysis, the trial achieved its primary objective by demonstrating statistically significant improvements in HbA1c (long-term blood sugar) for TTP399 compared to placebo at week 12 (p=0.03). TTP399 was well tolerated with similar incidences of treatment-emergent adverse events overall and by system organ class in both treatment groups. The study had no report of diabetic ketoacidosis in either treatment group. There was no incidence of severe hypoglycemia in the treated group and one incident in the placebo group. Patients taking TTP399 experienced fewer symptomatic hypoglycemic episodes: two subjects taking TTP399 reported at least one event compared to eight subjects taking placebo. “I am very pleased that part 2 of the study confirmed the positive results and effects we saw in part 1. A once-a-day pill that reduces HbA1c and improves time in range with continuous glucose monitoring, without increasing hypoglycemia or any signal for adverse events, is a big win for the future care of type 1 diabetes,” said Dr. John Buse, Director of the North Carolina Translational and Clinical Sciences Institute and of the Diabetes Center at the University of North Carolina School of Medicine and pri...