Canagliflozin: effects in overweight and obese subjects without diabetes mellitus.
OBJECTIVE
To evaluate the effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on body weight in overweight and obese subjects (body mass index [BMI] ≥27 and <50 kg/m(2) ).


METHODS
This 12-week, Phase 2b, randomized, double-blind study enrolled 376 subjects without diabetes mellitus who received canagliflozin 50, 100, or 300 mg or placebo once daily. The primary endpoint was the percent change in body weight from baseline through Week 12.


RESULTS
Canagliflozin increased urinary glucose excretion in a dose-dependent manner and produced statistically significant reductions in body weight compared with placebo (least squares mean percent changes from baseline of -2.2%, -2.9%, -2.7%, and -1.3% with canagliflozin 50, 100, and 300 mg and placebo; P < 0.05 for all comparisons). Overall adverse event (AE) rates were similar across groups. Canagliflozin was associated with higher rates of genital mycotic infections in women, which were generally mild and led to few study discontinuations. Osmotic diuresis-related AE rates were low and similar across groups.


CONCLUSIONS
In overweight and obese subjects without diabetes mellitus, canagliflozin significantly reduced body weight compared with placebo and was generally well tolerated.
Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA.
Harold E
HE
Bays
Richard
R
Weinstein
Gordon
G
Law
William
W
Canovatchel
D000328:Adult; D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects / Q000502:physiology; D000068896:Canagliflozin; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005947:Glucose / Q000378:metabolism; D005960:Glucosides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000503:physiopathology; D050177:Overweight / Q000188:drug therapy* / Q000503:physiopathology; D051247:Sodium-Glucose Transport Proteins / Q000037:antagonists & inhibitors* / Q000187:drug effects; D013876:Thiophenes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
D019440:Anti-Obesity Agents; D005960:Glucosides; D051247:Sodium-Glucose Transport Proteins; D013876:Thiophenes; D000068896:Canagliflozin; D005947:Glucose