The study is designed to evaluate whether TTP399 is well tolerated when administered as an add-on to insulin therapy and can improve daily glucose profiles and HbA1c in people living with type 1 diabetes.
(Republished from the UNC Health Care and UNC School of Medicine Newsroom)
John Buse, MD, PhD, director of the North Carolina Translational and Clinical Sciences Institute and of the UNC Diabetes Center at the UNC School of Medicine, is the principal investigator in a new Phase 1b/@ study evaluating a compound called TTP399 for the treatment of type 1 diabetes.
“It is very exciting to launch this effort to potentially develop a completely novel pill therapy for type 1 diabetes,” Buse said. “This disease is characterized by a huge burden of care on more than one million Americans affected and with limited treatment options. The UNC team is very hopeful that better treatments for type 1 diabetes will be near at hand.”
TTP399 is manufactured by vTv Therapeutics Inc. of High Point, North Carolina, which is sponsoring the trial. The study is being conducted with support from JDRF, the leading global organization funding type 1 diabetes (T1D) research.
The study is designed to evaluate whether TTP399 is well tolerated when administered as an add-on to insulin therapy and can improve daily glucose profiles and HbA1c in people living with T1D. Results from the Phase1b part of the study are expected in early 2018.
TTP399 is an orally available glucokinase enzyme (GK) activator that is designed to target GK activation only in the liver for superior glucose control. In the liver, GK is a key regulator of glucose metabolism, and its activation has been shown to increase glucose utilization, which in turn lowers blood glucose. In a six-month Phase 2b clinical trial of TTP399 in patients with type 2 diabetes, TTP399 demonstrated a statistically significant reduction in HbA1c levels in all TTP399 dose groups compared with placebo. TTP399 was also found to be well-tolerated without increased incidences of hypoglycemia and hyperlipidemia compared to placebo.
“We’ve gathered promising data in our clinical studies in type 2 diabetes and are eager to explore the potential of TTP399 as an insulin-adjunctive therapy in type 1 diabetes,” said Carmen Valcarce, Ph.D., executive vice president, chief scientific officer, vTv Therapeutics. “We are in a unique position to develop next-generation therapies with JDRF and the UNC team in our corner, and the simplici-T1 study is a very important stepping stone on the way to reaching our goal to improve the treatment of type 1 diabetes.”