Evaluation of TTP399 in Patients With Type 1 Diabetes (SimpliciT1)
Sponsored by vTv Therapeutics, in collaboration with JDRF
Focus Areas: Glucose Control Therapies
What is This Study?
This Phase 1 and Phase 2 study measured the effectiveness and safety of TTP399, a glucokinase activator taken once a day as a potential add-on therapy for those with type 1 diabetes. Phase 1 evaluated the safety of different TTP399 dosage regimens over one week of daily dosing, and Phase 2 evaluated the safety and efficacy of a TTP399 dosing regimen over 12 weeks of daily dosing.
Why do We Care?
Currently no oral medications are approved for the treatment of type 1 diabetes in the United States. While SGLT inhibitors are often used off-label for glycemic control, the FDA has not approved them for use in type 1 diabetes (T1D) because of the risk of diabetic ketoacidosis (DKA). If this drug is shown to be safe and effective for treating T1D, it could become the first oral medication approved in the U.S.
When Might we See Results?
Preliminary results were presented in February of 2020 and they were very positive. Statistical analysis demonstrated significant improvements in HbA1c by week 12 in those taking TTP399 compared to those on placebo. There were no reports of DKA in either group. Patients taking TTP399 did not experience any severe hypoglycemia and reported fewer hypoglycemic episodes overall compared to the other group.