Number (%) of Patients

Placebo

N = 515

Ertugliflozin 5 mg

 N = 519

Ertugliflozin 15 mg

 N = 510

* The three placebo controlled studies included one monotherapy trial and two add-on combination trials with metformin or with metformin and sitagliptin. † Includes: genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis. Percentages calculated with the number of female patients in each group as denominator: placebo (N=235), ertugliflozin 5 mg (N=252), ertugliflozin 15 mg (N=245). ‡ Includes: balanitis candida, balanoposthitis, genital infection, and genital infection fungal. Percentages calculated with the number of male patients in each group as denominator: placebo (N=280), ertugliflozin 5 mg (N=267), ertugliflozin 15 mg (N=265). § Includes: cystitis, dysuria, streptococcal urinary tract infection, urethritis, urinary tract infection. ¶ Includes: vulvovaginal pruritus and pruritus genital. Percentages calculated with the number of female patients in each group as denominator: placebo (N=235), ertugliflozin 5 mg (N=252), ertugliflozin 15 mg (N=245). # Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia. Þ Includes: thirst, dry mouth, polydipsia, and dry throat.  

Female genital mycotic infections† 3.0% 9.1% 12.2% 

Male genital mycotic infections‡ 0.4% 3.7% 4.2% 

Urinary tract infections§ 3.9% 4.0% 4.1% 

Headache 2.3% 3.5% 2.9% 

Vaginal pruritus¶ 0.4% 2.8% 2.4% 

Increased urination# 1.0% 2.7% 2.4% 

Nasopharyngitis 2.3% 2.5% 2.0% 

Back pain 2.3% 1.7% 2.5% 

Weight decreased 1.0% 1.2% 2.4% 

ThirstÞ 0.6% 2.7% 1.4% 

Volume Depletion 

Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion, particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2). In patients with moderate renal impairment, adverse reactions related to volume depletion (e.g., dehydration, dizziness postural, presyncope, syncope, hypotension, and orthostatic hypotension) were reported in 0%, 4.4%, and 1.9% of patients treated with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively. Ertugliflozin may also increase the risk of hypotension in other patients at risk for volume contraction [see Use in Specific Populations (8.5, 8.6)].

Ketoacidosis 

Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) ertugliflozin-treated patients and 0.0% of comparator-treated patients [see Warnings and Precautions (5.3)]. 

Impairment in Renal Function