New GLP-1 Medication Lowers A1c Six Months after Treatment Stopped

Transition Therapeutics, Inc., announced the results from a Phase 2 clinical study of gastrin analogue, TT-223, in patients with Type 2 diabetes. Patients who received the highest daily dose of TT-223 for 12 weeks and completed the entire study without adjusting their diabetes therapies experienced a statistically significant reduction in HbA1c of 1.13%, 6 months after completing TT-223. Patients who had received placebo treatment experienced a 0.22% HbA1c reduction 6 months post-treatment. HbA1c is a reflection of a person's average glucose level and is used by doctors as a measure of glucose management. Post prandial and AUC (area under the curve) glucose showed improvement versus placebo but not against baseline at 3 and 6 months post-treatment, while fasting blood glucose and mixed meal tolerance insulin parameter tests did not show improvement. No detectable changes in weight were observed. 

There were no treatment-related serious adverse events. The most common adverse event was nausea, which was generally mild to moderate and decreased in frequency and severity over the treatment period. 

"These data are very encouraging and supports the gastrin based approach. The progressive reduction in HbA1c levels six months after completion of treatment suggests potential disease-modifying properties of gastrin based therapies and differentiates them from other diabetes treatments," said Dr. Tony Cruz, Chairman and Chief Executive Officer. 

The study was a randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability and efficacy of once-daily subcutaneous injections of TT-223. The study enrolled Type 2 diabetes patients who were unable to achieve adequate glucose control.  

The study consisted of two main stages, a 12 week treatment period and a 6 month follow-up period. Patients continued their current background diabetes therapy through both stages. 

The once-daily dose of TT-223 was titrated as tolerated to the maximum dose during the first three weeks, and patients remained on the highest tolerated dose for the remaining nine weeks of the treatment period. 

After the completion of the treatment period, patients were followed for an additional six months to monitor the safety and efficacy of the TT-223 therapy. 

Transition and Eli Lilly and Company have entered into a licensing and collaboration agreement granting Lilly exclusive worldwide rights to develop and commercialize gastrin based therapies. 

Gastrin based therapies are an emerging class of potential disease-modifying therapies for patients with diabetes, and have been shown to provide sustained improvement in glycemic control in preclinical models and early clinical studies. Sustained improvement in glycemic control is a key goal for patients with diabetes in order to alleviate the symptoms of hyperglycemia, prevent diabetic complications, and improve their overall quality of life.

News Release – Transition Therapeutics Jan. 25, 2010