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Phase 3 Results Show Canagliflozin As Add-On Therapy To Metformin And Pioglitazone Significantly Lowers Blood Sugar Levels In Adult Patients With Type 2 Diabetes

BARCELONA, Spain, Nov. 9, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced that its investigational medicine canagliflozin substantially lowered blood glucose levels compared to placebo when used as add-on therapy in patients with type 2 diabetes who are inadequately controlled with the antihyperglycemic medications metformin and pioglitazone. These results were presented at the 4th World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy). 

The data presented are the latest Phase 3 results for canagliflozin, which is being evaluated across a spectrum of patients with type 2 diabetes. Results from the study (known as DIA3012) showed that canagliflozin, dosed once daily at 100 mg or 300 mg 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). The overall incidence of adverse events (AEs) was generally similar across all treatment arms.

"Given the global diabetes epidemic and the significant burden faced by patients who suffer from uncontrolled diabetes, it is critical that we evaluate new therapies in combination with existing antihyperglycemic therapies," said Dr. Thomas Forst, lead investigator on the study from the University of Mainz in Mainz, Germany. "The efficacy and safety profile for canagliflozin in this trial is encouraging. This data combined with other results seen to date, show that canagliflozin may provide added benefit in managing important diabetes parameters when used alone or in addition to existing diabetes treatments."

In secondary efficacy endpoint measures of the study, both the canagliflozin 100 mg and 300 mg 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 (-5.3 mmHg, p<0.01 and -4.7 mmHg, p<0.05, vs. -1.2 mmHg, respectively). Reductions in fasting plasma glucose were consistent with the primary endpoint for canagliflozin 100 mg and 300 mg, compared to placebo (-1.49 and -1.84 mmol/L vs. 0.14 mmol/L, respectively, p<0.001). Increases in high-density lipoprotein cholesterol were observed with canagliflozin 100 mg and 300 mg, compared to placebo [7.2% (0.08 mmol/L), p<0.05, and 8.9% (0.10 mmol/L), p<0.001, vs. 2.4% (0.02 mmol/L), respectively], and increases in low-density lipoprotein cholesterol were also seen [7.1% (0.08 mmol/L) and 11.3% (0.19 mmol/L) vs. -0.4% (-0.10 mmol/L), respectively]. Canagliflozin decreased triglyceride levels at the 300 mg dose [-1.7% (-0.16 mmol/L), p<0.01)].  Triglyceride levels increased at the 100 mg dose [3.1% (-0.06 mmol/L), p=ns)], though placebo was associated with a higher increase [15.3% (0.10 mmol/L)].

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