Boehringer Ingelheim and Eli Lilly have announced the data from the Phase 3 study of once-daily Tradjenta (linagliptin) 5mg tablets, used as an adjunct to diet and exercise to improve glycemic control in black or African American adults with type 2 diabetes mellitus, whose blood sugar was not adequately controlled.
Linagliptin is a prescription medicine that is used alongside diet and exercise to lower blood sugar and is the first and only member of the dipeptidyl peptidase-4 (DPP-4) inhibitor class to be approved at one dosage strength.
The 24-week Phase 3 study randomised 106 patients to linagliptin and 120 to placebo and found that linagliptin showed haemoglobin A1c (HbA1c or A1C) reduction of 0.88%, compared to 0.24% in the placebo group.
Arkansas Diabetes and Endocrinology Center spokesperson and lead investigator of the study James Thrasher said the findings support the efficacy and safety profile of linagliptin as a treatment option for African American adult patients with type 2 diabetes.
Boehringer Ingelheim clinical development and medical affairs senior vice president, John Smith, said: "This study suggests that linagliptin provides black or African American adult patients with another option to improve control of their blood sugar and it also reaffirms Boehringer Ingelheim and Lilly Diabetes' shared commitment to address the needs of the millions of Americans living with type 2 diabetes."
In January 2011 both companies signed an alliance to combine Boehringer Ingelheim's research-driven innovation and Lilly's innovative research and experience in the field of diabetes.
Image: Eli Lilly and Company's global headquarters in Indianapolis, US. Photo courtesy of: Guanaco152003.