TAK-875 versus placebo or glimepiride in type 2 diabetes mellitus: a phase 2, randomised, double-blind, placebo-controlled trial
The Lancet, 04/30/2012
Burant CF et al. - TAK-875 significantly improved glycaemic control in patients with type 2 diabetes with minimum risk of hypoglycaemia. The results show that activation of free fatty acid receptor 1 (FFAR1) is a viable therapeutic target for treatment of type 2 diabetes.
The authors undertook a phase 2, randomised, double-blind, and placebo-controlled and active-comparator-controlled trial in outpatients with type 2 diabetes who had not responded to diet or metformin treatment.
Patients were randomly assigned equally to receive placebo, TAK-875 (6.25, 25, 50, 100, or 200 mg), or glimepiride (4 mg) once daily for 12 weeks.
Patients and investigators were masked to treatment assignment.
The primary outcome was change in haemoglobin A1c (HbA1c) from baseline.
Analysis included all patients randomly assigned to treatment groups who received at least one dose of double-blind study drug.
426 patients were randomly assigned to TAK-875 (n=303), placebo (n=61), and glimepiride (n=62).
At week 12, significant least-squares mean reductions in HbA1c from baseline occurred in all TAK-875 (ranging from -1.12% [SE 0.113] with 50 mg to -0.65% [0.114] with 6.25 mg) and glimepiride (-1.05% [SE 0.111]) groups versus placebo (-0.13% [SE 0.115]; p value range 0.001 to <0.0001).
Treatment-emergent hypoglycaemic events were similar in the TAK-875 and placebo groups (2% [n=7, all TAK-875 groups] vs 3% [n=2]); significantly higher rates were reported in the glimepiride group (19% [n=12]; p value range 0.010—0.002 vs all TAK-875 groups).
Incidence of treatment-emergent adverse events was similar in the TAK-875 overall (49%; n=147, all TAK-875 groups) and placebo groups (48%, n=29) and was lower than in the glimepiride group (61%, n=38).
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