Description

Trelagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is a highly selective dipeptidyl peptidase-4 inhibitor that is typically used as an add on treatment when the first line treatment of metformin is not achieving the expected glycemic goals; though it has been approved for use as a first line treatment when metformin cannot be used.

Study subjects meeting any of the following criteria will not be included in this study: Patients under treatment with trelagliptin for type 2 diabetes at the start of screening. Patients with a diagnosis of type 1 diabetes. Patients with severe renal impairment or renal failure (e.g., eGFR < 30 mL/min/1.73 m2 or on dialysis). Patients with serious heart disease or a cerebrovascular disorder, or a serious pancreatic, blood, or other disease. Patients with a history of gastrointestinal resection. Patients with a proliferative diabetic retinopathy. Patients with malignancy. Patients with a history of hypersensitivity or allergy to DPP-4 inhibitors. Patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant. Patients who may need to add or discontinue concomitant medication or change the dose during the study period. Patients who will require treatment with a prohibited concomitant medication during the study period. Patients participating in other clinical studies. Patients assessed as ineligible for any other reason by the investigators.

No study has performed in patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.

(provide cautious dosage to the following patients): The following patients or circumstances Patients with moderate kidney function disorder Patients undergoing treatment with sulfonylurea drugs or insulin medication [there are reports of severe hypotension with use in combination with other DPP-4 inhibitors] Hypopituitarism or hypoadrenalism Malnutrition, starvation, irregular eating patterns, insufficient eating, or hyposthenia Vigorous exercise Patients who consume excessive alcohol

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Store at 25°C; excursions permitted to 15°-30°C. Dispense medication in the original container to protect from exposure to high humidity and light. Keep out of the reach of children