m a Factorial Study with Ertugliflozin and Sitagliptin as Add-on Combination Therapy with Metformin Compared to Individual Components Alone*
Sitagliptin 100 mg
Ertugliflozin 5 mg
Ertugliflozin 15 mg
Ertugliflozin 5 mg +Sitagliptin 100 mg
Ertugliflozin 15 mg + Sitagliptin 100 mg
* N includes all randomized and treated patients with a baseline measurement of the outcome variable. At Week 26 the primary HbA1c endpoint was missing for 13%, 10%, 11% , 11%, and 12% of patients and during the trial rescue medication was initiated by 6%, 6%, 3%, 2%, and 0% of patients randomized to sitagliptin, ertugliflozin 5 mg, ertugliflozin 15 mg, ertugliflozin 5 mg + sitagliptin, and ertugliflozin 15 mg + sitagliptin, respectively. Missing Week 26 measurements were imputed using multiple imputation with a mean equal to the baseline value of the patient. Results included measurements collected after initiation of rescue medication. For those subjects who did not receive rescue medication and had values measured at 26 weeks, the mean change from baseline for HbA1c was -1.1%, -1.1%, -1.1%, -1.5% and -1.6% for sitagliptin, ertugliflozin 5 mg, ertugliflozin 15 mg, ertugliflozin 5 mg + sitagliptin, and ertugliflozin 15 mg + sitagliptin, respectively. † Intent-to-treat analysis using ANCOVA adjusted for baseline value and baseline eGFR. ‡ p<0.001 compared to control group. § p<0.03 compared to control group.
HbA1c (%) N = 242 N = 244 N = 247 N = 237 N = 241
Baseline (mean) 8.5 8.6 8.6 8.6 8.6
Change from baseline (LS mean†) -1.0 -1.0 -1.0 -1.4 -1.4
Difference from
Sitagliptin -0.4‡ (-0.6, -0.2) -0.4‡ (-0.5, -0.2)
Ertugliflozin 5 mg -0.4‡ (-0.5, -0.2)
Ertugliflozin 15 mg -0.4‡ (-0.6, -0.2)
(LS mean†, 95% CI)
Patients [N (%)] with HbA1c <7% 93 (38.5) 72 (29.3) 83 (33.7) 126 (53.3) 123 (50.9)
FPG (mg/dL) N = 246 N = 250 N = 247 N = 240 N = 241
Baseline (mean) 177.4 184.1 179.5 183.8 177.2
Change from baseline (LS mean†) -24.3 -34.0 -34.6 -41.1 -44.3
Difference from
Sitagliptin -16.8‡ (-23.2, -10.4) -20.0‡ (-26.4, -13.6)
Ertugliflozin 5 mg -7.0§ (-13.3, -0.7)
Ertugliflozin 15 mg -9.8§ (-16.1, -3.4)
(LS mean†, 95% CI)
The mean baseline body weight was 89.8 kg, 88.6 kg, 88.0 kg, 89.5 kg, and 87.5 kg in the sitagliptin 100 mg, ertugliflozin 5 mg, ertugliflozin15 mg, ertugliflozin 5 mg + sitagliptin 100 mg, and ertugliflozin 15 mg + sitagliptin 100 mg groups, respectively. The mean changes from baseline to Week 26 were -0.4 kg, -2.6 kg, -3.4 kg, -2.4 kg, and -2.7 kg in the sitagliptin 100 mg, ertugliflozin 5 mg, ertugliflozin 15 mg, ertugliflozin 5 mg + sitagliptin 100 mg, and ertugliflozin 15 mg + sitagliptin 100 mg groups, respectively. The difference from sitagliptin 100 mg (95% CI) for ertugliflozin 5 mg + sitagliptin 100 mg was -1.9 kg (-2.6, -1.3) and for ertugliflozin 15 mg + sitagliptin 100 mg was -2.3 kg (-3.0, -1.6