Pancreatitis [see Warnings and Precautions (5.1)] 

Hypotension [see Warnings and Precautions (5.2)] 

Ketoacidosis [see Warnings and Precautions (5.3)] 

Acute Kidney Injury and Impairment in Renal Function [see Warnings and Precautions (5.4)] 

Urosepsis and Pyelonephritis [see Warnings and Precautions (5.5)] 

Lower Limb Amputation [see Warnings and Precautions (5.6)] 

Heart Failure [see Warnings and Precautions (5.7)] 

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.8)] 

Genital Mycotic Infections [see Warnings and Precautions (5.9)] 

Hypersensitivity Reactions [see Warnings and Precautions (5.10)] 

Increases in Low-Density Lipoprotein (LDL-C) [see Warnings and Precautions (5.11)] 

Severe and Disabling Arthralgia [see Warnings and Precautions (5.12)] 

Bullous Pemphigoid [see Warnings and Precautions (5.13)] 

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Ertugliflozin and Sitagliptin 

The safety of concomitantly administered ertugliflozin and sitagliptin has been eva luated in 990 patients with type 2 diabetes mellitus treated for 26 weeks in three studies; a factorial study of ertugliflozin 5 mg or 15 mg in combination with sitagliptin 100 mg once daily compared to the individual components, a placebo-controlled study of ertugliflozin 5 mg or 15 mg as add-on therapy to sitagliptin 100 mg and metformin once daily, and a placebo-controlled study of initial therapy with ertugliflozin 5 mg or 15 mg once daily in combination with sitagliptin 100 mg once daily [see Clinical Studies (14)]. The incidence and type of adverse reactions in these three studies were similar to the adverse reactions seen with ertugliflozin and described below in Table 1.

Ertugliflozin 

Pool of Placebo-Controlled Trials 

The data in Table 1 are derived from a pool of three 26-week, placebo-controlled trials. Ertugliflozin was used as monotherapy in one trial and as add-on therapy in two trials [see Clinical Studies (14)]. These data reflect exposure of 1,029 patients to ertugliflozin with a mean exposure duration of approximately 25 weeks. Patients received ertugliflozin 5 mg (N=519), ertugliflozin 15 mg (N=510), or placebo (N=515) once daily. The mean age of the population was 57 years and 2% were older than 75 years of age. Fifty-three percent (53%) of the population was male and 73% were Caucasian, 15% were Asian, and 7% were Black or African American. At baseline the population had diabetes for an average of 7.5 years, had a mean HbA1c of 8.1%, and 19.4% had established microvascular complications of diabetes. Baseline renal function (mean eGFR 88.9 mL/min/1.73 m2) was normal or mildly impaired in 97% of patients and moderately impaired in 3% of patients.

Table 1 shows common adverse reactions associated with the use of ertugliflozin. These adverse reactions were not present at baseline, occurred more commonly on ertugliflozin than on placebo, and occurred in at least 2% of patients treated with either ertugliflozin 5 mg or ertugliflozin 15 mg.