HbA1c (%) N = 96 N = 98 N = 96 

  Baseline (mean) 9.0 8.9 9.0 

  Change from baseline (LS mean†) -0.6 -1.6 -1.5 

  Difference from placebo (LS mean† and 95% CI)  -1.0‡ (-1.3, -0.7) -0.9‡ (-1.3, -0.6) 

Patients [N (%)] with HbA1c <7% 9 (9.3)  36 (37.1)  32 (32.9)  

FPG (mg/dL) N = 96 N = 98 N = 96 

  Baseline (mean) 207.5 198.0 187.7 

  Change from baseline (LS mean†) -11.8 -47.1 -50.8 

  Difference from placebo (LS mean†, 95% CI)  -35.4‡ (-47.3, -23.4) -39.1‡ (-51.4, -26.8) 

The mean baseline body weight was 95.0 kg, 90.8 kg, and 91.2 kg in the placebo, ertugliflozin 5 mg + sitagliptin 100 mg, and ertugliflozin 15 mg + sitagliptin 100 mg groups, respectively. The mean changes from baseline to Week 26 were -0.5 kg, -2.7 kg, and -2.8 kg in the placebo, ertugliflozin 5 mg + sitagliptin 100 mg, and ertugliflozin 15 mg + sitagliptin 100 mg groups, respectively. The difference from placebo (95% CI) for ertugliflozin 5 mg + sitagliptin 100 mg was -2.1 kg (-3.1, -1.2) and for ertugliflozin 15 mg + sitagliptin 100 mg was -2.3 kg (-3.3, -1.3).

The mean baseline systolic blood pressure was 127.4 mmHg, 130.7 mmHg, and 129.2 mmHg in the placebo, ertugliflozin 5 mg + sitagliptin 100 mg, and ertugliflozin 15 mg + sitagliptin 100 mg groups, respectively. The mean changes from baseline to Week 26 were 1.6 mmHg, -2.4 mmHg, and -3.5 mmHg in the placebo, ertugliflozin 5 mg + sitagliptin 100 mg, and ertugliflozin 15 mg + sitagliptin 100 mg, respectively. The difference from placebo (95% CI) for ertugliflozin 5 mg + sitagliptin 100 mg was -4.0 mmHg (-7.2, -0.8) and for ertugliflozin 15 mg + sitagliptin 100 mg was -5.2 mmHg (-8.4, -1.9).

16 HOW SUPPLIED/STORAGE AND HANDLING

STEGLUJAN (ertugliflozin and sitagliptin) tablets are available in the strengths listed below:

STEGLUJAN 5 mg/100 mg: ertugliflozin 5 mg and sitagliptin 100 mg tablets are beige, almond-shaped, debossed with "554" on one side and plain on the other side. They are supplied as follows:

NDC 0006-5367-03 unit-of-use bottles of 30

NDC 0006-5367-06 unit-of-use bottles of 90

NDC 0006-5367-07 bulk bottles of 500

STEGLUJAN 15 mg/100 mg: ertugliflozin 15 mg and sitagliptin 100 mg tablets are brown, almond-shaped, debossed with "555" on one side and plain on the other side. They are supplied as follows:

NDC 0006-5368-03 unit-of-use bottles of 30

NDC 0006-5368-06 unit-of-use bottles of 90

NDC 0006-5368-07 bulk bottles of 500

Storage of Bottles 

Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (between 59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store in a dry place.

17 PATIENT COUNSELING INFORMATION

Advise he patient to read the FDA-approved patient labeling (Medication Guide).

Instructions 

Instruct patients to read the Medication Guide before starting STEGLUJAN (ertugliflozin and sitagliptin) and to reread it each time the prescription is renewed.