Patients treated with TTP399 had improved Time in Range (TIR), reduced time in hyperglycemia, fewer hypoglycemic events, and lower bolus insulin dose
HIGH POINT, N.C., Sept. 18, 2019 (GLOBE NEWSWIRE) — vTv Therapeutics Inc. (Nasdaq: VTVT), today presented additional positive data from its phase 2 Simplici-T1 study in patients with type 1 diabetes (T1D) at the 55th Annual Meeting of the European Association for the Study of Diabetes.
In a poster titled “Results from the sentinel and learning phase of the Simplici-T1 study, the first clinical trial to test activation of glucokinase as an adjunctive treatment for type 1 diabetes”, Dr. Carmen Valcarce, Chief Scientific Officer at vTv Therapeutics presented new continuous glucose monitor (CGM) and insulin dose data from the patients with complete CGM profiles in the completed Phase 2 – Part 1 of the study. Key results presented included:
- TTP399 treatment (n=6) increased Time in Range from baseline to end of treatment by 11% (2.7 hours) (p=0.055) per day (24 hours), and by 12% (1.7 hours) (p=0.04) during the critical waking hours (7am-9pm) relative to placebo (n=9).
- TTP399 treatment reduced the total daily mealtime bolus insulin dose by 23% compared to 4% for placebo while significantly improving glycemic control.
- Patients in the treatment group experienced fewer Level 1 (≥54-70 mg/dl) and Level 2 (<54 mg/dl) hypoglycemic events than patients in the placebo group.
“These new clinical data enhance the very promising topline efficacy results we announced for this part of the study in June, where TTP399 reduced HbA1c levels by 0.7% relative to placebo,” said Steve Holcombe, president and CEO, vTv Therapeutics. “We believe that these results, if confirmed in the larger, on-going portion of the study, would strongly position TTP399 for phase 3 development to help address the needs of patients suffering with T1D.”
A copy of the poster is available on the company website at http://vtvtherapeutics.com/publications/.
About the Simplici-T1 Study:
Simplici-T1 is a multi-center, randomized, double-blind, adaptive study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of TTP399 as an adjunct to insulin therapy in adult patients with T1D. The study is being conducted with support from JDRF, the leading global organization funding research in type 1 diabetes.
The Phase 2 learn-and-confirm study is being conducted in two parts to evaluate the safety and efficacy of TTP399 in T1D patients over twelve weeks of daily dosing. Part 1 enrolled 19 patients on both insulin pumps and CGMs. The topline results from Phase 2 – Part 1 were reported in June 2019:
- The study met its primary endpoint of change in A1c from baseline after 12 weeks of treatment. Patients treated with TTP399 (n=8) showed a statistically significant mean reduction in HbA1c of 0.7% (p=0.03) at 12 weeks relative to the placebo group (n=11).
- TTP399 was well tolerated with similar incidences of treatment-emergent adverse events overall and by system organ class. The study had neither a serious adverse event nor an incident of diabetic ketoacidosis reported.
Part 2 is now fully-enrolled with patients utilizing a treatment regimen that includes either insulin pumps or multiple daily injection therapy, with CGMs optional. Topline results from the study are expected in the first quarter of 2020.
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of diabetes, Alzheimer’s disease, and inflammatory disorders. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), and genetic mitochondrial diseases.
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