Lower Limb Amputation 

 

Across seven Phase 3 clinical trials in which STEGLATRO was studied as monotherapy and in combination with other antihyperglycemic agents, non-traumatic lower limb amputations occurred in 1 of 1,450 (0.1%) in the non-STEGLATRO group, 3 of 1,716 (0.2%) in the STEGLATRO 5 mg group, and 8 of 1,693 (0.5%) in the STEGLATRO 15 mg group.

 

Hypoglycemia 

 

The incidence of hypoglycemia by study is shown in Table 3.

 

Table 3: Incidence of Overall* and Severe† Hypoglycemia in Placebo-Controlled Clinical Studies in Patients with Type 2 Diabetes Mellitus 

* Overall hypoglycemic events: plasma or capillary glucose of less than or equal to 70 mg/dL. † Severe hypoglycemic events: required assistance, lost consciousness, or experienced a seizure regardless of blood glucose.  

 

Monotherapy (26 weeks) Placebo

(N = 153) STEGLATRO

5 mg

(N =156) STEGLATRO

15 mg

(N = 152) 

Overall [N (%)]  1 (0.7) 4 (2.6) 4 (2.6) 

Severe [N (%)]  0 (0.0) 0 (0.0) 2 (1.3) 

Add-on Combination Therapy with Metformin (26 weeks) Placebo

(N = 209) STEGLATRO

5 mg

(N = 207) STEGLATRO

15 mg

(N = 205) 

Overall [N (%)]  9 (4.3) 15 (7.2) 16 (7.8) 

Severe [N (%)]  1 (0.5) 1 (0.5) 0 (0.0) 

Add-on Combination Therapy with Metformin and Sitagliptin (26 weeks)  Placebo

(N = 153) STEGLATRO

5 mg

(N = 156) STEGLATRO

15 mg

(N = 153) 

Overall [N (%)]  5 (3.3) 7 (4.5) 3 (2.0) 

Severe [N (%)]  1 (0.7) 1 (0.6) 0 (0.0) 

In Combination with Insulin and/or an Insulin Secretagogue in Patients with Moderate Renal Impairment Placebo

(N = 133) STEGLATRO

5 mg

(N = 148) STEGLATRO

15 mg

(N = 143) 

Overall [N (%)] 48 (36.1) 53 (35.8) 39 (27.3) 

Severe [N (%)] 3 (2.3) 5 (3.4) 3 (2.1) 

 

Genital Mycotic Infections 

 

In the pool of three placebo-controlled clinical trials, the incidence of female genital mycotic infections (e.g., genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis) occurred in 3%, 9.1%, and 12.2% of females treated with placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively (see Table 1). In females, discontinuation due to genital mycotic infections occurred in 0% and 0.6% of patients treated with placebo and STEGLATRO, respectively. 

 

In the same pool, male genital mycotic infections (e.g., balanitis candida, balanoposthitis, genital infection, genital infection fungal) occurred in 0.4%, 3.7%, and 4.2% of males treated with placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively (see Table 1). Male genital mycotic infections occurred more commonly in uncircumcised males. In males, discontinuations due to genital mycotic infections occurred in 0% and 0.2% of patients treated with placebo and STEGLATRO, respectively. Phimosis was reported in 8 of 1729 (0.5%) male ertugliflozin-treated patients, of which four required circumcision.

 

Laboratory Tests