Real world study of short term efficacy, safety, and tolerability of canagliflozin 100 mg initiation in type 2 diabetes mellitus patients during hot humid Indian summer.

BACKGROUND AND AIM

To assess short term (3 months) efficacy, safety, and tolerability of canagliflozin 100 mg among type 2 diabetes mellitus (T2DM) initiated during hot humid Indian summer.

METHODS

A prospective, observational, multi-center study of 300 T2DM patients with inadequate glycemic control (i.e., HbA1c of ≥6.5%) with or without other antihyperglycemic agents (AHA) were enrolled in the study in the month of March. The objective of the study was to assess the efficacy that is changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), blood pressure (BP), lipid profile, body mass index (BMI) and safety of canagliflozin with regards to genitourinary infection, fall, diabetic keto acidosis (DKA) episodes, blood ketone and beta-hydroxybutyrate levels. All patients were initiated on canagliflozin 100 mg once daily for 12 weeks, irrespective of background medications.

RESULTS

At 12 weeks, a significant reduction was observed in all the glycemic parameters,BMI, BP, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C). However, a nonsignificant reduction in estimated glomerular filtration rate (eGFR) was observed at 12 weeks. A total of 9 adverse events were reported including 2 episodes of urinary tract infection (UTI) and 4 episodes of genital infection. The blood ketone, beta-hydroxybutyrate levels were found to be within normal limits and no episode of DKA was reported at 12 weeks. None of our patients had reported any volume depletion related adverse events viz. postural hypotension, giddiness etc. CONCLUSION: Canagliflozin 100 mg can be safely initiated in type 2 diabetes patients during hot humid Indian summer, irrespective of background medications and is effective and well tolerated.