statistically significant improvements in A1C and FPG compared with placebo (Table 9). In the entire study population (patients on TRADJENTA in combination with sulfonylurea and metformin), a mean reduction from baseline relative to placebo in A1C of -0.6% and in FPG of -12.7 mg/dL was seen. Rescue therapy was used in 5.4% of patients treated with TRADJENTA 5 mg and in 13% of patients treated with placebo. Change from baseline in body weight did not differ significantly between the groups.
Table 9 Glycemic Parameters in Placebo-Controlled Study for TRADJENTA in Combination with Metformin and Sulfonylurea* TRADJENTA 5 mg + Metformin + SU Placebo + Metformin + SU
SU = sulfonylurea
*Full analysis population using last observation on study
A1C (%)
Number of patients n = 778 n = 262
Baseline (mean) 8.2 8.1
Change from baseline (adjusted mean) -0.7 -0.1
Difference from placebo (adjusted mean) (95% CI) -0.6 (-0.7, -0.5)
Patients n (%) achieving A1C <7% 243 (31.2) 24 (9.2)
FPG (mg/dL)
Number of patients n = 739 n = 248
Baseline (mean) 159.2 162.6
Change from baseline (adjusted mean) -4.6 8.1
Difference from placebo (adjusted mean) (95% CI) -12.7 (-18.1, -7.3)
16 HOW SUPPLIED/STORAGE AND HANDLING
TRADJENTA tablets are available as light red, round, biconvex, bevel-edged, film-coated tablets containing 5 mg of linagliptin. TRADJENTA tablets are debossed with “D5” on one side and the Boehringer Ingelheim logo on the other side.
They are supplied as follows:
Bottles of 30 (NDC 0597-0140-30)
Bottles of 90 (NDC 0597-0140-90)
Bottles of 1000 (NDC 0597-0140-10)
If repackaging is required, dispense in a tight container as defined in USP.
Storage
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Store in a safe place out of reach of children.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling.
17.1 Instructions
Inform patients of the potential risks and benefits of TRADJENTA and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.
Instruct patients to take TRADJENTA only as prescribed. If a dose is missed, advise patients not to double their next dose.
Instruct patients to read the Patient Information before starting TRADJENTA therapy and to reread it each time the prescription is renewed. Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.
17.2 Laboratory Tests
Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and A1C levels, with a goal of decreasing these levels toward the normal range. A1C monitoring is especially useful for eva luating long-term glycemic contro
