Janssen Research & Development announced results from a Phase 3 study (known as DIA3012) that showed that its investigational medicine canagliflozin substantially lowered blood glucose levels compared to placebo when used as add-on therapy in adult patients with type 2 diabetes who are inadequately controlled with metformin (Glucophage; Bristol-Myers Squibb) and pioglitazone (Actos; Takeda). Canagliflozin is an investigational sodium glucose co-transporter 2 (SGLT2) inhibitor.
Results from the study showed that canagliflozin, dosed once daily at 100mg or 300mg in addition to metformin and pioglitazone, had statistically greater A1C reductions at 26 weeks relative to placebo (change from baseline, -0.89% and -1.03%, vs. -0.26%, respectively, P<0.001).
In secondary efficacy endpoint measures of the study, both the canagliflozin 100mg and 300mg dose groups provided reductions in body weight compared to placebo (-2.8% and -3.8% vs. -0.1%, respectively, P<0.001) and reductions in systolic blood pressure (-5.3mmHg, P<0.01 and -4.7mmHg, P<0.05, vs. -1.2mmHg, respectively). Reductions in fasting plasma glucose were consistent with the primary endpoint for canagliflozin 100mg and 300mg, compared to placebo (-1.49mmol/L and -1.84mmol/L vs. 0.14mmol/L, respectively, P<0.001). Increases in high-density lipoprotein cholesterol were observed with canagliflozin 100mg and 300mg, compared to placebo [7.2% (0.08mmol/L), P<0.05, and 8.9% (0.1mmol/L), P<0.001, vs. 2.4% (0.02mmol/L), respectively], and increases in low-density lipoprotein cholesterol were also seen [7.1% (0.08mmol/L) and 11.3% (0.19mmol/L) vs. -0.4% (-0.1mmol/L), respectively]. Canagliflozin decreased triglyceride levels at the 300mg dose [-1.7% (-0.16mmol/L), P<0.01)]. Triglyceride levels increased at the 100mg dose [3.1% (-0.06 mmol/L), P=ns)], though placebo was associated with a higher increase [15.3% (0.1mmol/L)].
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