rom baseline for HbA1c were -0.8%, -0.6%, and -0.7% for glimepiride, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively. † Intent-to-treat analysis using ANCOVA adjusted for baseline value, prior antihyperglycemic medication and baseline eGFR. ‡ Non-inferiority is declared when the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.
HbA1c (%) N = 437 N = 447 N = 440
Baseline (mean) 7.8 7.8 7.8
Change from baseline (LS mean†) -0.6 -0.5 -0.5
Difference from glimepiride (LS mean†, 95% CI) 0.2‡ (0.0, 0.3) 0.1‡ (-0.0, 0.2)
Patients [N (%)] with HbA1c <7% 208 (47.7) 177 (39.5) 186 (42.2)
The mean baseline body weight was 86.8 kg, 87.9 kg, and 85.6 kg in the glimepiride, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively. The mean changes from baseline to Week 52 were 0.6 kg, -2.6 kg, and -3.0 kg in the glimepiride, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively. The difference from glimepiride (95% CI) for ertugliflozin 5 mg was -3.2 kg (-3.7, -2.7) and for ertugliflozin 15 mg was -3.6 kg (-4.1, -3.1).
16 HOW SUPPLIED/STORAGE AND HANDLING
SEGLUROMET (ertugliflozin and metformin hydrochloride) tablets are available in the strengths listed below:
ertugliflozin 2.5 mg and metformin hydrochloride 500 mg tablets are pink, oval, debossed with "2.5/500" on one side and plain on the other side. They are supplied as follows:
NDC 0006-5369-03 unit-of-use bottles of 60
NDC 0006-5369-06 unit-of-use bottles of 180
NDC 0006-5369-07 bulk bottles of 500
ertugliflozin 2.5 mg and metformin hydrochloride 1000 mg tablets are pink, oval, debossed with "2.5/1000" on one side and plain on the other side. They are supplied as follows:
NDC 0006-5373-03 unit-of-use bottles of 60
NDC 0006-5373-06 unit-of-use bottles of 180
NDC 0006-5373-07 bulk bottles of 500
ertugliflozin 7.5 mg and metformin hydrochloride 500 mg tablets are red, oval, debossed with "7.5/500" on one side and plain on the other side. They are supplied as follows:
NDC 0006-5370-03 unit-of-use bottles of 60
NDC 0006-5370-06 unit-of-use bottles of 180
NDC 0006-5370-07 bulk bottles of 500
ertugliflozin 7.5 mg and metformin hydrochloride 1000 mg tablets are red, oval, debossed with "7.5/1000" on one side and plain on the other side. They are supplied as follows:
NDC 0006-5374-03 unit-of-use bottles of 60
NDC 0006-5374-06 unit-of-use bottles of 180
NDC 0006-5374-07 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 the patient to read the FDA-approved patient labeling (Medication Guide).
Instructions
Instruct patients to read the Medication Guide before starting SEGLUROMET (ertugliflozin and metformin) and to reread it each time the prescription is renewed.
Inform patients of the potential risks and benefits of S
