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ADA conference: Janssen's canagliflozin trial success

SGLT2 inhibitor demonstrates superiority to Januvia and Amaryl in diabetes treatment

American Diabetes Association (ADA) Philadelphia meeting 2012

Janssen's canagliflozin demonstrated substantial and sustained glycaemic improvements in five phase III studies of the SGLT2 inhibitor presented at the American Diabetes Association (ADA) meeting in Philadelphia.

Kirk Ways, compound development team leader for canagliflozin at Janssen, said: "The results in each of these studies suggest that canagliflozin could provide an effective therapeutic option for adults with type 2 diabetes in a range of clinical settings."

Two of the stand out trials showcased canagliflozin's potential as a monotherapy, comparing it to the current standard treatments of Januvia and Sanofi's Amaryl (glimepiride).

Phase III trial DIA3015 was a 52-week randomised, double-blind, active-controlled study involving 755 adult patients with inadequate glycaemic control on maximally effective doses of metformin and sulfonylurea.

Patients were given once-daily doses of canagliflozin (300mg) or Januvia (100mg) and those treated with canagliflozin had a "substantial and sustained decrease in A1C levels, with a significantly greater reduction relative to [Januvia] after 52 weeks," Janssen said.

Adverse events related to genital mycotic infections in men and women, and those related to an osmotic diuresis such as increased urination, were more frequent in patients treated with canagliflozin than Januvia.

However, a similar incidence of urinary tract infections was seen in the two treatment groups.

The genital infections and osmotic diuresis related adverse events were generally mild to moderate in intensity and most genital infections responded to topical or oral antifungal therapy. A similar incidence of hypoglycaemic episodes was reported with canagliflozin and sitagliptin.

The second of the trials, known as DIA3009, was a 52-week randomised, double-blind, active-controlled phase III trial in 1,450 adult patients with inadequate glycaemic control on maximally effective doses of metformin.

Patients were randomised and treated once daily with either canagliflozin (100mg or 300mg) or Amaryl (with up-titration of Amaryl allowed throughout the 52-week period). Patients treated with canagliflozin had a sustained decrease in A1C, with statistically greater A1C-lowering for canagliflozin 300mg after 52 weeks when compared to glimepiride (-0.93 per cent and -0.81 per cent, respectively.

The incidence of adverse events and discontinuations due to these incidents were generally similar across all treatment arms.

Adverse events were mild to moderate and the overall incidence was balanced across treatment arms. Adverse events related to osmotic diuresis such as increased urination, genital mycotic infections in men and women, and urinary tract infections were more frequent in patients treated with canagliflozin than Amaryl.

“Canagliflozin has the potential to be administered as monotherapy in patients who are inadequately controlled with diet and exercise alone, as an add-on therapy in patients being treated with metformin alone or in combination with sulfonylureas, and in patients with moderate renal impairment," Ways concluded.

By Dominic Tyer, managing editor, PMLiVE & PME 

11th June 2012

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