rescue medication was initiated by 18%, 3%, and 1% of patients randomized to placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively. Missing Week 26 measurements were imputed using multiple imputation with a mean equal to the baseline value of the patient. Results include measurements collected after initiation of rescue medication. For those patients who did not receive rescue medication and had values measured at 26 weeks, the mean changes from baseline for HbA1c were -0.2%, -0.7%, and -1.0% for placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively. † Intent-to-treat analysis using ANCOVA adjusted for baseline value, prior antihyperglycemic medication, menopausal status and baseline eGFR. ‡ p<0.001 compared to placebo.
HbA1c (%) N = 207 N = 205 N = 201
Baseline (mean) 8.2 8.1 8.1
Change from baseline (LS mean†) -0.2 -0.7 -0.9
Difference from placebo (LS mean†, 95% CI) -0.5‡ (-0.7, -0.4) -0.7‡ (-0.9, -0.5)
Patients [N (%)] with HbA1c <7% 38 (18.4) 74 (36.3) 87 (43.3)
FPG (mg/dL) N = 202 N = 199 N = 201
Baseline (mean) 169.1 168.1 167.9
Change from baseline (LS mean†) -8.7 -30.3 -40.9
Difference from placebo (LS mean†, 95% CI) -21.6‡ (-27.8, -15.5) -32.3‡ (-38.5, -26.0)
The mean baseline body weight was 84.5 kg, 84.9 kg, and 85.3 kg in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively. The mean changes from baseline to Week 26 were -1.4 kg, -3.2 kg, and -3.0 kg in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively. The difference from placebo (95% CI) for ertugliflozin 5 mg was -1.8 kg (-2.4, -1.2) and for ertugliflozin 15 mg was -1.7 kg (-2.2, -1.1).
The mean baseline systolic blood pressure was 129.3 mmHg, 130.5 mmHg, and 130.2 mmHg in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively. The mean changes from baseline to Week 26 were -1.8 mmHg, -5.1 mmHg, and -5.7 mmHg in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively. The difference from placebo (95% CI) for ertugliflozin 5 mg was -3.3 mmHg (-5.6, -1.1) and for ertugliflozin 15 g was -3.8 mmHg (-6.1, -1.5).
* Data to the left of the vertical line are observed means (non-model-based) excluding values occurring post glycemic rescue. Data to the right of the vertical line represent the final Week 26 data, including all values regardless of use of glycemic rescue medication and use of study drug, with missing Week 26 values imputed using multiple imputation (26-MI) with a mean equal to the baseline value of the patient (see Table 6).
Figure 3: HbA1c (%) Change over Time in a 26-Week Placebo-Controlled Study for Ertugliflozin Used in Combination with Metformin in Patients with Type 2 Diabetes Mellitus*
Figure 3
14.3 In Combination with Sitagliptin versus Ertugliflozin Alone and Sitagliptin Alone, as Add-on to Metformin
A total of 1,233 patients with type 2 diabetes mellitus with inadequate glycemic control (HbA1c between 7.5% and 11%) on metformin monotherapy (≥1,500 mg/day for ≥8 weeks) participated in a randomized, double-blind, 26-week, active controlled study (NCT NCT02099110) to e
