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vTv Therapeutics Announces Publication in Diabetes Care of Results from SimpliciT-1 Study of TTP399 in Patients with Type 1 Diabetes
The Phase 2 study was conducted in two parts under a treat-to-target protocol to evaluate the safety and efficacy of TTP399 in T1D patients over 12 weeks of daily dosing following a multi-week insulin optimization and placebo run-in period.
Published results from the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c, as previously announced. Interestingly, it also resulted in a clinically relevant (~40%) reduction in the frequency of severe or symptomatic hypoglycemia, as compared to placebo. Abnormal serum and urine ketones were detected less frequently in participants in the TTP399 group than in the placebo group. These data suggest the potential of TTP399 to lower HbA1c and reduce hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes. vTv looks forward to initiation of its first pivotal study of TTP399 later this year.
“An adjunctive therapy that protects against the main acute, life-threatening complications of type 1 diabetes while maintaining or improving glycemic control would represent a substantial advancement in clinical standard of care,” said Dr.
The publication, titled “The SimpliciT1 study: A randomized, double-blind placebo-controlled, Phase 1b/2 adaptive study of TTP399, a hepatoselective glucokinase activator, for adjunctive treatment of type 1 diabetes mellitus”, is published online ahead of print at https://care.diabetesjournals.org/lookup/doi/10.2337/dc20-2684.
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 type 1 diabetes and inflammatory disorders, including psoriasis. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy. For more information, please visit https://vtvtherapeutics.com/ or follow us on Twitter: @vTvTherapeutics.
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Source: vTv Therapeutics Inc.