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according to the indian council of medical research - india diabetes ( icmr - indiab ) study , india has about 62.4 million people with diabetes and 77.2 million people with prediabetes .
treatment guidelines recommend glycosylated hemoglobin a1c ( hba1c ) goal of 7.0% or less for most of the patients along with the management of other factors that contribute to the complications of type 2 diabetes mellitus ( t2 dm ) viz . ,
however , despite the availability of multiple classes of antihyperglycemic agents ( ahas ) , it was found that only 31% of subjects studied in icmr - indiab study had hba1c of < 7% , underscoring that management of the diabetes remains challenging .
canagliflozin is a new molecule belonging to sodium glucose co - transporter 2 ( sglt2 ) inhibitor class of aha and has been recently approved by dcgi ( drugs controller general of india ) in 2014 for management of t2 dm in india .
sglt2 inhibitors lower the blood glucose levels by blocking the reabsorption of filtered glucose in the kidneys and thereby increasing urinary glucose excretion .
these agents work through a novel insulin - independent mechanism , complementing the other ahas .
their unique mechanism of action , coupled with pleiotropic benefits on weight and blood pressure , make them attractive choices as add - on therapy to manage t2 dm not controlled on other medications .
canagliflozin in various clinical trials has shown to improve glycemic control , body weight , and blood pressure .
this brief communication aims to report the clinical outcomes in indian patients treated with canagliflozin in a real - world setting and the changes in glycemic and other parameters following 3 - 5 months of therapy .
it should be the first report of its kind after canagliflozin was approved for clinical use in india .
data were collected from clinic database and included patients who were taking canagliflozin daily for 3 months since the day of prescription in april 2015 to august 2015 .
all patients were above 18 years of age and had estimated glomerular filtration rate > 45 ml / min/1.73 m with t2 dm .
other medicines were altered as and when required depending on the patient 's clinical and laboratory parameters .
comparisons between baseline and follow - up measures in patients receiving canagliflozin 100 mg were made using paired t - test .
all statistical analyses were conducted using graphpad prism version 6.02 for windows , graphpad software , la jolla california usa , www.graphpad.com .
baseline characteristics of the patients are mentioned in table 1 . in total , nine patients were reviewed in this study of which five were male and four were female .
these patients had a mean age of 47.9 years and mean duration of t2 dm of 6.7 years .
mean baseline fasting blood glucose ( fbg ) and postprandial blood glucose ( ppbg ) of all patients were 226.1 mg / dl and 348.3 mg / dl , respectively .
baseline body weight and body mass index ( bmi ) was available for all patients , and mean values were 69.9 kg and 26.1 kg / m respectively . two - third of patients were not hypertensives while remaining one - third were hypertensives and treated by some antihypertensive agents at the time of initiating canagliflozin .
baseline low - density lipoprotein cholesterol ( ldl - c ) was available for eight patients , and the mean value was 105.5 mg / dl with all patients being on statins .
baseline characteristics of t2 dm patients treated with canagliflozin the mean duration of follow - up was 16 weeks ( standard deviation [ sd ] = 3.5 ) .
n = 9 ) , the mean hba1c was 7.0% ( sd = 1.3 ) . among patients with both baseline and follow - up hba1c results ( n
= 8) , the mean decreased from 9.0% ( sd = 1.9 ) to 6.8% ( sd = 1.3 ) , difference of means being 2.2% ( 95% confidence interval [ ci ] = 3.2 to 1.2 ) ( p < 0.005 ) [ table 2 ] . during the baseline period , most patients had hba1c levels > 7.0% ( 75% of patients ) .
after canagliflozin therapy as add - on to ongoing regimens , the distribution shifted with proportion of patients with hba1c > 7.0% decreasing significantly to 33.3% .
after 16 weeks of mean canagliflozin treatment , 66.7% of patients achieved a hba1c level of 7.0% as compared to 25% of patients at baseline [ figure 1 ] .
follow - up data of t2 dm patients treated with canagliflozin distribution of baseline and follow - up glycosylated hemoglobin ( hba1c ) levels .
cana : canagliflozin efficacy of canagliflozin was further assessed by changes in the fbg , ppbg , bmi , and weight .
after 16 weeks of treatment duration , mean decrease in fbg from baseline was 90.3 mg / dl ( 95% ci = 142.3 to 38.3 ) ( p < 0.005 ) and mean decrease in ppbg from baseline was 137.6 mg% ( 95% ci = 218.6 to  56.55 ) ( p < 0.005 ) .
body weight and bmi decreased significantly by 2.06 kg ( 95% ci = 3.790 to 0.3213 ) ( p < 0.05 ) and 0.78 kg / m ( 95% ci = 1.440 to 0.1219 ) ( p < 0.05 ) , respectively [ table 2 ] . at baseline ,
the mean number of ahas used by the patients were 2.4 ( sd = 0.53 ) .
the most common medications used were metformin ( 100% of patients ) followed by sulfonylureas ( sus ) ( 77.8% ) , thiazolidinedione ( tzd ) ( 33.3% ) , insulin ( 22.2% ) , and alpha - glucosidase inhibitors ( agis ) ( 11.1% ) .
five out of nine patients were on two ahas at baseline while remaining four patients on three ahas . at baseline ,
compared to the use of ahas during the baseline period , there was a downward trend in the use of metformin , tzd , & agi , and sus during the follow - up period [ figure 2 ] .
there was also a downward trend in the dosage requirement of on - going medications .
in one patient metformin and agi had to be discontinued due to gastro - intestinal side effects .
the two patients on insulin had decreased dose requirement by 12% and 25% respectively , as compared to the baseline dose at the end of follow - up period after addition of canagliflozin 100 mg .
in one patient both metformin and agi had to be discontinued due to gastro intesitinal side effects .
agi : alpha glucosidase inhibitors ; tzd : thiazolidinedione ; met : metformin ; su : sulfonylurea ; cana : canagliflozin three out of nine patients were on anti - hypertensive medications , angiotensin receptor blockers ( arbs ) being most common .
both systolic and diastolic blood pressures were within normal limits at the baseline ; however , there was a marginal decrease in the blood pressure after addition of canagliflozin [ table 2 ] .
in one patient , with combination of arb and a diuretic , the dose of arb was reduced to half the dose at baseline and the diuretic was discontinued .
of the patients with follow - up ldl - c results ( n = 9 ) , the mean ldl - c was 88.8 mg% ( sd = 47.9 ) . among patients with both baseline and follow - up ldl - c results ( n
= 8) , the mean decreased from 105.5 mg / dl ( sd = 21.8 ) to 91.4 mg / dl ( sd = 50.6 ) , difference of means being - 14.13 mg / dl ( 95% ci = 56.9 to -28.7 ) ( p = ns ) [ table 2 ] .
three patients out of eight with baseline results for ldl - c had increase in ldl - c values while remaining five patients had decrease in the ldl - c levels .
safety of canagliflozin was assessed by regular follow - up with patients for signs and symptoms of expected adverse events ( aes ) as per the prescribing information of canagliflozin .
patients had also come to the clinic once in 12 weeks for physical check - up and follow - up .
however , in patients with downward trends of glycemic parameters , down - titration of active ahas such as sus and insulin were done as required in order to avoid hypoglycemia .
there were two reports ( 22% of total patients ) of genital mycotic infection ( gmi ) following canagliflozin .
both the patients were continued on the drug and prescribed local and oral anti - fungal medicines .
one patient complained of polyuria while none had any symptoms of volume loss or osmotic changes .
no patient had complaints of hypotension , dehydration or hematuria , thromboembolism , coronary event , or stroke during follow - up .
in this brief communication , we characterize and examine short - term outcomes in patients who received canagliflozin in a real - world setting soon after it became available in india .
all patients with canagliflozin were already on more than one class of ahas at the baseline , and the majority had baseline hba1c levels of 7.5% or higher .
this indicates that prior to treatment with canagliflozin , patients with t2 dm were inadequately managed and did not meet the recommended hba1c levels , despite prior use of multiple ahas .
significant reductions in hba1c levels along with other glycemic parameters such as fbg and ppbg were observed in these patients , after canagliflozin treatment .
decrease in the requirement or dose of other ahas and insulin can add to cost reduction of management of t2 dm in long - term ; however , this will depend on the durability of canagliflozin .
the 104 weeks long study of canagliflozin compared against glimepiride had shown that canagliflozin to be efficacious in reducing hba1c all through the trial in a sustained manner .
the pleiotropic benefits of canagliflozin in terms of weight loss and blood pressure reduction were seen in these patients .
this can be a big advantage in a country like india , where diabetes and obesity are increasing rapidly .
as per the recent data published in icmr - indiab-3 study on prevalence of overweight and obesity in india , the projected figures are alarmingly high with nearly 88 million overweight and 395 million with some obesity
. the mean weight reduction of more than 2 kg from baseline with canagliflozin can reduce some of the burden of obesity and overweight in the patients with t2 dm .
low incidence of aes in this study assures the safety of canagliflozin in management of t2 dm .
though two reports of gmi were reported in follow - up period , both the patients were well managed with local and oral anti - fungal medicines .
the recent warning of diabetic ketoacidosis with sglt2 inhibitors was kept in mind during prescription of canagliflozin , and urinary ketone was assessed in all patients at follow - up .
although this study had assessed use of canagliflozin in real - world setting , the follow - up period was limited to short timeframe of 16 weeks , and the number of patients were very few . while this dataset is not mature enough to thoroughly investigate persistence , 100% of patients in this study were continued on canagliflozin till the next follow - up .
the patients in this study might not be a representative of larger t2 dm population , but baseline characteristics and disease profile were similar to most t2 dm patients .
this review provides insights into the real - world prescriptions and short - term outcomes of patients treated with canagliflozin 100 mg daily during the early days after dcgi approval .
further research should investigate both short - term and long - term follow - up in larger patient population , and whether canagliflozin use has significant impact on t2 dm patients from india in real - world setting .
manash p. baruah has received honorarium from jenssen metabolics , johnsons and johnsons pvt . ltd .
dr . manash p. baruah has received honorarium from jenssen metabolics , johnsons and johnsons pvt . ltd .
objective : this study is aimed to evaluate the characteristics , treatment , and outcomes of patients treated with canagliflozin in the real - world setting within the first 4 months of the product 's availability in india.patients and methods : it is a retrospective study with data collected from indian clinical database . 
 patients aged 18 and above who were prescribed canagliflozin were included in this study . 
 all the patients were on other antihyperglycemic agents ( ahas ) before the initiation of canagliflozin.results:overall , nine patients were included in the study , and data for these patients with mean duration of follow - up of 16 weeks was analyzed . 
 mean age was 47.9 years and mean duration of type 2 diabetes was 6.7 years . among patients with available laboratory data at baseline and follow - up , 
 mean glycosylated hemoglobin a1c ( hba1c ) decreased from 9.0% at baseline to 6.8% at follow - up ( p < 0.005 ) ; mean weight reduced from 69.9 kg at baseline to 67.9 kg at follow - up . 
 when compared to baseline , the usage and or dose of other ahas were reduced during follow-up.conclusion:canagliflozin after it became available in india , improved all glycemic parameters and also reduced the weight of the type two diabetic patients who were poorly controlled by multiple ahas .