Clinical-stage pharmaceutical company TransTech Pharma's liver-selective glucokinase activator (GKA) for type two diabetes, TTP399, has demonstrated normalised HbA1c and no hypoglycemia in a clinical trial on subjects with stable doses of metformin.
TTP399 shows no GKA activation in the pancreas and does not interrupt the binding of glucokinase (GK) with the GK regulatory protein (GKRP).
TransTech president and CEO Dr Adnan Mjalli said, despite the various treatments that are currently available, many patients struggle to control their type two diabetes mellitus.
"I am thrilled to see the results of this study, which are supportive of the evidence that identifies GK as the 'gatekeeper' of glucose homeostasis," Mjalli added.
"These results suggest TTP399 dosing for longer than six weeks would result in normalising HbA1c in subjects irrespective of their starting HbA1c."
Shown to function in case of plasma glucose above normal levels, TTP399 is viewed to act as a glucose sensor and controller, as the drug demonstrates no effect on plasma glucose if the level is within normal range.
The drug completed a six-week, multicentre, Phase IIa study in type two diabetic subjects on stable doses of metformin.
As it demonstrated a reduction in HbA1c of 0.92 with p1c baseline of 7.5% or less, it achieved the American Diabetes Association's goal of reducing HbA1c values to seven percent or less, and up to 85% of those subjects reached the target of 6.5% or less, set by the American Association of Clinical Endocrinologists (AACE).
While no placebo-treated subjects reached the AACE goal, normalisation of HbA1c was achieved without inducing hypoglycemia and after six-week treatment.