versus placebo or glimepiride in type 2 diabetes mellitus: a phase 2, randomised, double-blind, placebo-controlled trial.
Takeda Pharmaceutical, a Japan-based pharmaceutical company, has decided to voluntarily terminate the development activities of its type 2 diabetes investigational drug, fasiglifam (TAK-875
), it was reported on Friday.
The oral, highly potent, and selective free fatty acid receptor 1 agonist TAK-875 significantly improved glycemic control in patients with type 2 diabetes without increasing treatment-emergent hypoglycemic events in a phase II, randomized, controlled trial comparing TAK-875, glimepiride, and placebo.
At weeks 4, 8, and 12 of treatment, all of the 303 patients who were randomized to receive treatment with TAK-875 at doses ranging from 6.25 to 200 mg once daily, as well as all of the 62 patients randomized to receive treatment with 4 mg glimepiride (a sulphonylurea that acts as an insulin secretagogue) once daily, achieved significant least-squares mean reductions from baseline in hemoglobin Alc, compared with the 61 patients randomized to a placebo group.
Additionally, the percentage of patients reaching the American Diabetes Association target of Hb[A.sub.1c] less than 7.0% by 12 weeks was generally similar in the 25- to 200-mg TAK-875 and glimepiride groups, and changes, relative to the placebo group, were significant, they said.
About 2% and 3% of the TAK-875 patients and the placebo patients, respectively, had treatment-emergent hypoglycemic events during treatment, compared with 19% of the glimepiride patients, and the events were mild to moderate in intensity in all groups.
Burant and his colleagues promise to raise many questions about the potential of TAK-875 in the treatment of type 2 diabetes, according to Dr.
TAK-875 appeared to have no effect on insulin resistance in this study.
18 October 2011 - Japan's Takeda Pharmaceutical Company Limited (TYO:4502) said today it had commenced a Phase III clinical study programme for its investigational Type 2 diabetes therapy TAK-875.
The programme will be carried out across the US, Latin America, and Europe, Takeda said, noting that TAK-875 is the first GPR40 agonist to reach late stage (Phase III) clinical development.
M2 PHARMA-September 12, 2011-Takeda advances TAK-875 into Phase III studies for Type 2 diabetes treatment(C)2011 M2 COMMUNICATIONS
12 September 2011 - Japanese Takeda Pharmaceutical Company Limited (TYO:4502) said today it had advanced TAK-875 into Phase III studies for the treatment of Type 2 diabetes in Japan.