vTv Therapeutics Announces Positive Study Results of Potential First-in-Class Oral Adjunctive Therapy for T1D
This news coverage was created in partnership with JDRF through the JDRF – Beyond Type 1 Alliance.
On February 10, vTv Therapeutics announced positive study results from the second part of the Phase 2 Simplici-T1 Study of TTP399. TTP399 is a glucokinase activator taken once a day as a potential add-on therapy for those with type 1 diabetes. The trial spanned 12 weeks and studied the effectiveness and safety of the drug in those with type 1 using insulin therapy, comparing results with a placebo group. Participants taking TTP399 demonstrated meaningful reductions in HbA1c levels, fewer episodes of hypoglycemia and improved time in range. The study was completed with support from JDRF.
The main objective of the trial was to evaluate TTP399’s effect on HbA1c and overall, statistical analysis demonstrated significant improvements in HbA1c by week 12 in those taking TTP399 compared to those on placebo. There were no reports of diabetic ketoacidosis (DKA) in either group. Patients taking TTP399 did not experience any severe hypoglycemia and reported fewer hypoglycemic episodes overall compared to the other group.
Those conducting the study wanted to remove the possibility that excess insulin could be the cause of the A1c reductions, and performed another analysis as a result. In that analysis, patients taking TTP399 saw a 0.32 percent reduction in A1c, which the FDA classifies as clinically meaningful. These patients also demonstrated improved time in range by approximately two hours and a reduced daily mealtime bolus by 11 percent.
“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 principal investigator for this study.
It’s necessary to develop these adjunctive therapies because people with type 1 diabetes still find it hard to achieve optimal blood sugars and demonstrate an HbA1c of less than 7 percent. This glucokinase activator works by increasing the utilization of glucose in the liver and lowering blood sugar levels as a result. Simplici-T1 is the first study of its kind, testing the activation of glucokinase (GK) in type 1 diabetes (T1D) patients T1D with TTP399.
“The development of a safe and effective therapy that improves blood glucose control is a critical step toward eliminating the dangerous highs and lows associated with type 1 diabetes,” said Sanjoy Dutta, Ph.D., vice president of Research at JDRF. “The results from the Simplici-T1 trial indicate that TTP399 is a promising oral treatment option to help people with type 1 diabetes keep their HbA1c levels within a healthy range, and stay in a desirable blood glucose range for most of the day, while simplifying the daily management of the disease.”
To learn more about all the great T1D research being funded by JDRF, visit their research and impact page here.