A total of 464 patients with type 2 diabetes mellitus on metformin ≥1,500 mg/day and sitagliptin
100 mg/day participated in a randomised, multicentre, parallel-group study to evaluate the
efficacy and safety of ertugliflozin as add-on therapy. A total of 462 patients were analysed (2
patients in the ertugliflozin 15-mg group did not receive study medication).
The double-blind treatment period was 52 weeks in duration and divided into two 26-week phases
(phase A: weeks 1–26; phase B: weeks 27–52).
Patients on ≥1,500 mg/day metformin and sitagliptin 100 mg/day for ≥8 weeks with HbA1c
≥7.0% and ≤10.5% at screening were eligible to directly enter a placebo run-in period.
Patients on therapy for <8 weeks, on metformin <1,500 mg/day, on a dipeptidyl peptidase 4
inhibitor other than sitagliptin, or on a sulfonylurea were put on the appropriate treatments
through wash-off (and titration where appropriate) and dose stabilisation prior to the placebo
run-in period.9
Patients were randomised in a 1:1:1 manner to ertugliflozin 5 mg (n=156), ertugliflozin 15 mg
(n=155), or placebo (n=153) administered once daily in addition to continuation of background
metformin and sitagliptin therapy. 464 patients were randomised and 462 were analysed (2
patients in the ertugliflozin 15 mg group did not receive study medication).1
The primary efficacy end point was change from baseline in HbA1c at week 26.
Key secondary efficacy end points were change from baseline at week 26 in fasting plasma glucose,
body weight, and systolic blood pressure, and the proportion of patients with HbA1c <7.0% at
week 26.
Efficacy assessments were also performed at week 52, though no formal hypothesis testing was
conducted.
Safety analysis was conducted at week 26 (phase A) and week 52 (phase A+B). Safety assessments
included the number of patients with adverse events (AEs), including AEs prespecified for
inferential testing (symptomatic hypoglycaemia, AEs associated with genital mycotic infection,
urinary tract infection, and hypovolemia).