The study evaluated patients with type 1 diabetes and was presented at the Meeting of the European Association for the Study of Diabetes
vTv Therapeutics (NASDAQ:VTVT) has announced positive data from its Phase 2 Simplici-T1 study in type 1 diabetes patients.
As quoted in the press release:
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.”