Positive results from Phase III trial of Vokanamet/Invokamet (canagliflozin) plus metformin in Type 2 Diabetes-Janssen

Janssen R&D has announced results of a Phase III, randomized study showing that the use of initial combination therapy of Vokanamet/Invokamet (canagliflozin) plus metformin extended release (XR) in people with type 2 diabetes with higher A1C levels and who treat their type 2 diabetes with diet and exercise only � where monotherapy is unlikely to be adequate to reach glycemic goals � was effective and generally well tolerated. In the study, patients treated with canagliflozin in combination with metformin XR experienced greater reduction in A1C levels in comparison to those treated with either single agent. Additionally, from a pre-specified secondary endpoint, patients treated with the combination therapy showed significant weight reduction when compared with those treated with metformin XR.

Canagliflozin monotherapy at 100mg and 300mg showed similar and non-inferior results in lowering A1C and greater body weight reduction versus metformin XR alone. Canagliflozin as a monotherapy and in combination with metformin is not indicated for weight reduction. Overall, rates of serious adverse events (AEs) were low. Incidences of genital mycotic infections and osmotic diuresis, volume depletion and renal-related AEs and hypoglycemia were higher in the patients with canagliflozin. The data were accepted as a late-breaking poster for presentation during the 75th Annual Scientific Sessions of the American Diabetes Association.