Boehringer Ingelheim and Eli Lilly announced results of a Phase 3 study in African American adults that shows taking Tradjenta (linagliptin) 5mg once-daily tablets sgnificantly reduces hemoglobin A1c (HbA1c).
Tradjenta 5mg once-daily tablets is the first and only member of the dipeptidyl peptidase-4 (DPP-4) inhibitor class to be approved at one dosage strength.
Tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The drug is a DPP-4 inhibitor that does not require dose adjustments regardless of declining renal function or hepatic impairment. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.
In the 24-week study, 226 patients were randomized (106 to Tradjenta, and 120 to placebo) and received at least one dose of the study drug in order to be included in the safety analyses. HbA1c was measured every six weeks during the study and the difference between the groups was significantly different by six weeks and remained so throughout the study.
The number of patients experiencing adverse events was similar for the linagliptin and placebo groups. The most common adverse events reported in this trial were hyperglycemia (high blood sugar levels [Tradjenta 2.8 percent; placebo 9.2 percent]) and nasopharyngitis (inflammation of the nose or pharynx [Tradjenta 3.8 percent; placebo 5 percent]). Hypoglycemia occurred in three patients in the Tradjenta group and one patient in the placebo group, and none of the events required external assistance.
African American adults are disproportionately affected by type 2 diabetes. In the U.S., the risk of diabetes is 77 percent greater for non-Hispanic black adults, when compared to non-Hispanic white adults, with an estimated 18.7 percent (4.9 million) of all non-Hispanic black adults living with the disease. This is the first published trial of a DPP-4 inhibitor specifically conducted in black or African American adult patients with type 2 diabetes. The data were presented at the American Association of Clinical Endocrinologists (AACE) 21st annual Scientific and Clinical Congress.