|Clinical Data Should have Positive Phase 2 Results Coming soon|
TTP399 has been studied in a series of phase 1 and phase 2 clinical trials. In all studies, TTP399 has been safe and well tolerated, with no increased incidence of hypoglycemia compared to placebo. The results of these trials, suggest that our approach to glucokinase activation will avoid safety and tolerability issues associated with other GKAs, such as activation of glucokinase in the pancreas, stimulation of insulin secretion independent of glucose, hypoglycemia, increased lipids and liver toxicity. Further, we believe that TTP399 will compare favorably with other products in the market, as our trials have indicated that TTP399 may have higher efficacy than competing products, the ability to normalize HbA1c, and no contraindication for renal impairment.
We have completed a Phase 2 clinical trial of TTP399, a randomized, double-blind, parallel-group, placebo-controlled, six-week, multiple dose study in 151 type 2 diabetic patients whose glycemic parameters were not well-controlled on metformin. The trial was designed to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of TTP399 in formulation 1 and was conducted at 11 centers in the United States. Patients were randomized into four arms: TTP399 400 mg BID, TTP399 800 mg QD, TTP399 800 mg BID, and placebo. All patients remained on consistent doses of metformin throughout the trial.