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GKA shows improved type 2 glyceamic control

By Editor
14th June 2016
Latest news, Pharmaceutical Research

A new type of liver-selective glucokinase activator (GKA) has shown improved glyceamic control and insulin resistance in people with type 2 diabetes.

At the American Diabetes Association‘s 76th Scientific Sessions in New Orleans, vTv Therapeutics Inc presented results from an earlier pilot clinical study of with TTP399.

Unlike previous GKAs without liver selectivity, TTP399 did not induce hypoglycemia or have detrimental effects on plasma lipids, adding to the body of evidence demonstrating TTP399’s potential as an effective and sustainable treatment option for type 2 diabetes.

‘Clinical evidence’

In a poster presentation titled, “TTP399, a Novel, Liver Selective Glucokinase Activator: Results from a 10 Day Pilot Study in Patients with Type 2 Diabetes Mellitus (T2DM) Naïve to Drug”, researchers from vTv reviewed results showing that TTP399, currently being evaluated in the Phase 2b AGATA study, improved glyceamic control and insulin resistance in treatment-naïve diabetes patients. Importantly, TTP399 did not induce hypoglycemia or have detrimental effects on plasma lipids, as seen with previous GKAs that do not target the liver.

Dr Carmen Valcarce, chief scientific officer of vTv Therapeutics, said: “These results add to the body of preclinical and clinical evidence that support the potential of TTP399 for the treatment of diabetes.

“We hope to confirm the efficacy and safety of this approach and to demonstrate the durability of the effect in our ongoing Phase 2b AGATA study, and expect to report topline data in mid-2016.”

“Dual-acting GK activators developed by others caused high rates of hypoglycaemia and hyperlipidemia.

“We believe TTP399’s liver selectivity and preservation of the physiological regulation of GK—a unique attribute of our GKA—mitigates these side effects, making this compound potentially useful early in the disease in prediabetes or to intensify therapy without risk of hypoglycaemia.

“We hope to confirm the efficacy and safety of this approach and to demonstrate the durability of the effect in our ongoing Phase 2b AGATA study, and expect to report topline data in mid-2016.”

The study, part of the TTP399 clinical development plan, reported data collected from three doses of TTP399 compared to placebo in treatment-naïve, mild type 2 diabetes patients (A1c < 7 per cent) over a 10-day treatment period (16 patients received 50 mg, 200 mg or 400 mg oral doses of TTP399, 6 received placebo).

Results showed statistically significant improvements over placebo in insulin and glucose measures in patients receiving the two higher doses of TTP399, while reporting similar adverse events as those receiving placebo.

No hypoglycaemia or detrimental effects on plasma lipids were seen in any of the TTP399-treated patients.

The company expects to report top-line results in mid-2016 from the AGATA study, a 180-patient, Phase 2b randomised, placebo controlled, six-month duration study of TTP399 in type 2 diabetes patients.

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