OSAKA, Japan I May 16, 2013 I Takeda Pharmaceutical Company Limited (“Takeda”) announced today the results of a Phase III clinical trial (CCT-003) of fasiglifam (Development code:TAK-875) for the treatment of type 2 diabetes presented at the 56th Annual Meeting of the Japan Diabetes Society, being held from the 16th through 18th of May 2013 in Kumamoto, Japan. The results show that 25 mg and 50 mg fasiglifam, when administered once-daily, showed statistically significant and clinically relevant HbA1c lowering effect in type 2 diabetes patients.
Discovered by Takeda, fasiglifam is the first GPR40 agonist to reach late stage (phase III) clinical development, and the completed clinical findings to date have demonstrated glucose-lowering effects in patients with type 2 diabetes by stimulating glucose-dependent insulin secretion. The phase III randomized, double-blind, placebo-controlled 24-week study investigated the efficacy and safety of once-daily fasiglifam 25mg and 50mg in 192 Japanese patients with type 2 diabetes.
In the final evaluation at 24 weeks, a statistically significant reduction in HbA1c was found in patients treated with fasiglifam 25 mg (-0.75, 95% CI -0.985; -0.521) and fasiglifam 50 mg (-1.01, 95% CI -1.244; -0.777), respectively, compared to placebo. In subjects whose HbA1c levels reached the National Glycohemoglobin Standard Program (NGSP) glycemic target of under 6.9% accounted for 30.2%, 54.8%, and 13.8% of the fasiglifam 25 mg, fasiglifam 50 mg, and placebo groups, respectively; the higher percentages vs. placebo arm were statistically significant for both arms of fasiglifam. In addition, in patients with a baseline HbA1c below 8.4%, decreases were 0.41 and 0.62% in the fasiglifam 25mg and fasiglifam 50mg groups, respectively compared to decreases of 1.37and 1.40% in those with a baseline of >=8.4%. The study provided additional information regarding safety and tolerability of fasiglifam. Treatment emerging adverse events were mild to moderate, with no significant differences in incidence or types of adverse events between the fasiglifam groups and the placebo group.
“In this 24 week study in Japanese patients with type 2 diabetes, clinically important reductions in HbA1c were seen in patients treated with fasiglifam. If approved, fasiglifam has the potential to become an important new treatment option for diabetics. It is a novel glucose dependent insulin secretagogue with low risk of hypoglycemia,” said Kohei Kaku, M.D., Ph.D., Professor of Kawasaki Medical School who made the presentation at the symposium.
<Outline of the CCT-003 phase III clinical trial for fasiglifam that was presented at the 56th Annual Meeting of the Japan Diabetes Society>
Purpose:
To evaluate the efficacy and safety of fasiglifam in comparison to placebo, when given orally at a dose of 25 mg or 50 mg as once-daily treatment for a period of 24 weeks in Japanese patients with type 2 diabetes who had inadequate glycemic control on the treatment with diet and exercise
Study design:
Multicenter, randomized, double-blind, comparative
Control:
Placebo
No. of subjects:
192
Study period:
24 weeks
Primary endpoint:
Change from baseline in HbA1c levels at 24 weeks
Baseline HbA1c:
fasiglifam 25mg 7.84%, fasiglifam 50mg 7.69%, Placebo 7.83%
Efficacy:
– At 24 weeks, a statistically significant and clinically relevant reduction in HbA1c levels was found in patients treated with fasiglifam 25 mg (0.75%, 95% CI [-0.985, -0.521]) and fasiglifam 50 mg (1.01%, 95% CI [-1.244, -0.777]), respectively, compared to placebo.
– The percentage of patients whose HbA1c levels were reduced to the NGSP glycemic target of <6.9% was statistically significant in both fasiglifam arms
* Fasiglifam 25mg dose = 30.2% of patients
* Fasiglifam 50mg = 54.8% of patients
* Placebo = 13.8% of patients
– HbA1c of both the 25mg and the 50mg doses of fasiglifam maintained glucose-lowering effects at the same levels over the 24-week period.
Safety:
– The study provided additional information regarding safety and tolerability of fasiglifam 25mg and fasiglifam 50mg.
– Treatment emerging adverse events were mild to moderate, with no significant differences in incidence or types of adverse events between fasiglifam 25mg, fasiglifam 50mg and the placebo group.
– Incidence of hypoglycemia was similar to placebo for both fasiglifam 25mg and fasiglifam 50mg.
– The most frequently reported TEAEs (>=5%) were nasopharyngitis and upper respiratory tract inflammation.
SOURCE: Takeda Pharmaceutical
Fasiglifam (TAK-875), a Novel GPR40 Agonist Reduces HbA1c in a 24-Week Clinical Study – Phase III Study Results Presented at the 56th Annual Meeting of the Japan Diabetes Society
Published on: Thursday, 16 May 2013 06:52 PM
OSAKA, Japan I May 16, 2013 I Takeda Pharmaceutical Company Limited (“Takeda”) announced today the results of a Phase III clinical trial (CCT-003) of fasiglifam (Development code:TAK-875) for the treatment of type 2 diabetes presented at the 56th Annual Meeting of the Japan Diabetes Society, being held from the 16th through 18th of May 2013 in Kumamoto, Japan. The results show that 25 mg and 50 mg fasiglifam, when administered once-daily, showed statistically significant and clinically relevant HbA1c lowering effect in type 2 diabetes patients.
Discovered by Takeda, fasiglifam is the first GPR40 agonist to reach late stage (phase III) clinical development, and the completed clinical findings to date have demonstrated glucose-lowering effects in patients with type 2 diabetes by stimulating glucose-dependent insulin secretion. The phase III randomized, double-blind, placebo-controlled 24-week study investigated the efficacy and safety of once-daily fasiglifam 25mg and 50mg in 192 Japanese patients with type 2 diabetes.
In the final evaluation at 24 weeks, a statistically significant reduction in HbA1c was found in patients treated with fasiglifam 25 mg (-0.75, 95% CI -0.985; -0.521) and fasiglifam 50 mg (-1.01, 95% CI -1.244; -0.777), respectively, compared to placebo. In subjects whose HbA1c levels reached the National Glycohemoglobin Standard Program (NGSP) glycemic target of under 6.9% accounted for 30.2%, 54.8%, and 13.8% of the fasiglifam 25 mg, fasiglifam 50 mg, and placebo groups, respectively; the higher percentages vs. placebo arm were statistically significant for both arms of fasiglifam. In addition, in patients with a baseline HbA1c below 8.4%, decreases were 0.41 and 0.62% in the fasiglifam 25mg and fasiglifam 50mg groups, respectively compared to decreases of 1.37and 1.40% in those with a baseline of >=8.4%. The study provided additional information regarding safety and tolerability of fasiglifam. Treatment emerging adverse events were mild to moderate, with no significant differences in incidence or types of adverse events between the fasiglifam groups and the placebo group.
“In this 24 week study in Japanese patients with type 2 diabetes, clinically important reductions in HbA1c were seen in patients treated with fasiglifam. If approved, fasiglifam has the potential to become an important new treatment option for diabetics. It is a novel glucose dependent insulin secretagogue with low risk of hypoglycemia,” said Kohei Kaku, M.D., Ph.D., Professor of Kawasaki Medical School who made the presentation at the symposium.
<Outline of the CCT-003 phase III clinical trial for fasiglifam that was presented at the 56th Annual Meeting of the Japan Diabetes Society>
Purpose:
To evaluate the efficacy and safety of fasiglifam in comparison to placebo, when given orally at a dose of 25 mg or 50 mg as once-daily treatment for a period of 24 weeks in Japanese patients with type 2 diabetes who had inadequate glycemic control on the treatment with diet and exercise
Study design:
Multicenter, randomized, double-blind, comparative
Control:
Placebo
No. of subjects:
192
Study period:
24 weeks
Primary endpoint:
Change from baseline in HbA1c levels at 24 weeks
Baseline HbA1c:
fasiglifam 25mg 7.84%, fasiglifam 50mg 7.69%, Placebo 7.83%
Efficacy:
– At 24 weeks, a statistically significant and clinically relevant reduction in HbA1c levels was found in patients treated with fasiglifam 25 mg (0.75%, 95% CI [-0.985, -0.521]) and fasiglifam 50 mg (1.01%, 95% CI [-1.244, -0.777]), respectively, compared to placebo.
– The percentage of patients whose HbA1c levels were reduced to the NGSP glycemic target of <6.9% was statistically significant in both fasiglifam arms
* Fasiglifam 25mg dose = 30.2% of patients
* Fasiglifam 50mg = 54.8% of patients
* Placebo = 13.8% of patients
– HbA1c of both the 25mg and the 50mg doses of fasiglifam maintained glucose-lowering effects at the same levels over the 24-week period.
Safety:
– The study provided additional information regarding safety and tolerability of fasiglifam 25mg and fasiglifam 50mg.
– Treatment emerging adverse events were mild to moderate, with no significant differences in incidence or types of adverse events between fasiglifam 25mg, fasiglifam 50mg and the placebo group.
– Incidence of hypoglycemia was similar to placebo for both fasiglifam 25mg and fasiglifam 50mg.
– The most frequently reported TEAEs (>=5%) were nasopharyngitis and upper respiratory tract inflammation.
SOURCE: Takeda Pharmaceutical
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