A total of 461 patients with type 2 diabetes inadequately controlled on diet and exercise participated in a randomised, double-blind, 26-week, placebo-controlled study to evaluate the efficacy and safety of ertugliflozin monotherapy. These patients, who were not receiving any background antihyperglycaemic treatment for ≥8 weeks, were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily. The primary end point was changed from baseline HbA_1c at week 26.

A total of 621 patients with type 2 diabetes mellitus (T2DM) participated in a randomised, multicentre, parallel-group study to evaluate the efficacy and safety of ertugliflozin 5 or 15 mg in patients with T2DM and on metformin (MET) monotherapy.

The double-blind treatment period was 104 weeks in duration and divided into 2 phases (phase A: weeks 1–26; phase B: weeks 27–104, a 78-week extension period during which the placebo group received blinded glimepiride [if not rescued during phase A]).

The study population included patients ≥18 years of age with T2DM and HbA_1c ≥7.0% and ≤10.5% on MET monotherapy (≥1,500 mg/d for ≥8 weeks) and with a body mass index (BMI) 18.0–40.0 kg/m².

Patients were randomized in a 1:1:1 manner to ertugliflozin 5 mg (n=207), ertugliflozin 15 mg (n=205), or placebo (n=209) administered once daily in addition to continuation of background MET therapy.

Glycaemic rescue therapy (open-label glimepiride in phase A/blinded glimepiride in phase B if not rescued in phase A) was initiated for patients who met progressively stricter glycaemic thresholds during the trial.

The primary efficacy end point was change from baseline at week 26 in HbA_1c. Prespecified secondary efficacy end points were changes from baseline at week 26 in fasting plasma glucose, body weight, and systolic and diastolic blood pressure. Participants with HbA1c <7.0% at week 26 and proportions of those who received glycaemic rescue therapy were also evaluated.

Safety assessments included adverse event (AE) monitoring. Prespecified AEs included symptomatic hypoglycaemia and AEs associated with genital mycotic infection, urinary tract infection, and hypovolaemia.

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 HbA_1c ≥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 HbA_1c 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).