Takeda Announces the Results of Phase 3 Trial of Trelagliptin Succinate (SYR-472) for the Treatment of Type 2 Diabetes Mellitus at the 50th EASD Annual Meeting

September 17, 2014

Osaka, Japan, September 17, 2014 - Takeda Pharmaceutical Company Limited (Takeda) announced the results of a phase 3 trial of trelagliptin succinate (general name, development code: SYR-472) for the treatment of Type 2 diabetes mellitus at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting, which is being held in Vienna, Austria from September 15 - 19, 2014.

Trelagliptin succinate is a once-weekly dipeptidyl peptidase-IV (DPP-4) inhibitor. It controls blood glucose levels by selectively and continually inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, two incretin hormones that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels. Takeda has submitted the New Drug Application to the Ministry of Health, Labour and Welfare for this compound in March 2014.

″The results of this trial have proved the efficacy and safety of this therapeutic agent." said Nancy Joseph-Ridge, M.D., General Manager of Takeda’s Pharmaceutical Development Division. "Because of the complex nature of Type 2 diabetes, it is important to tailor treatment to meet the individual needs and conditions of each patient. I hope that this treatment, a once-weekly DPP-4 inhibitor, will become a new option for Type 2 diabetes patients. ″

[Results of Phase 3 Trial of Trelagliptin Succinate Treatment Announced at the EASD Annual Meeting]

Purpose	Study to evaluate the efficacy and safety of trelagliptin 100mg, once-weekly with alogliptin 25mg daily as a comparator in Japanese Type 2 diabetes patients with inadequate glycemic control despite diet and/or exercise therapy.
Study design	Multi-center, randomised, double-blind and parallel group study
Comparator	Alogliptin and placebo
Number of patients	243 patients (trelagliptin: 101 patients, alogliptin: 92 patients and placebo: 50 patients)
Treatment period	24 weeks
Main evaluation point	Change of HbA1c from the baseline at the end of 24-week treatment.
Efficacy	At the end of the treatment period, the least square mean difference (trelagliptin – alogliptin) of change from baseline in HbA1c was 0.11% (95% CI: -0.054 to 0.281). HbA1c decreased significantly in the trelagliptin and alogliptin groups compared to the placebo group. Non-inferiority of trelagliptin group to alogliptin group was attained (p < 0.0001). The trelagliptin group also showed sustained inhibition of DPP-4 activity throughout the treatment period.
Safety	The frequency of adverse events in the trelagliptin group was similar to those in the alogliptin group. No hypoglycemia was reported in the trelagliptin group.

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