PHILADELPHIA — Black patients with diabetes were more likely to experience significant reductions in HbA1c when using once-daily linagliptin 5-mg tablets, as compared with placebo, according to data presented at the American Association of Clinical Endocrinologists 21st Scientific and Clinical Congress.
Results from the phase 3 study associated linagliptin with a 0.88% reduction in HbA1c vs. 0.24% for placebo (P=.0002) at 24 weeks in black adult patients with diabetes. Patients in the linagliptin group were also significantly more likely to experience an HbA1c reduction of at least half a percent at the conclusion of the study, and more than half of the patients (55.3%) in the group had a reduction of 0.5% or more, compared with 28.3% in the placebo group (P<.0001).
Of the 226 patients enrolled, 106 were randomly assigned to linagliptin, and 120 to placebo. HbA1c was measured every 6 weeks.
James Thrasher, MD, FACE, researcher and clinician at Arkansas Diabetes and Endocrinology Center, and colleagues said their findings further confirm the efficacy and safety of linagliptin (Tradjenta, Boehringer Ingelheim) for the treatment of all patients with type 2 diabetes, including those in this patient population.
“This is a landmark study for Boehringer Ingelheinm and Eli Lilly, and I hope it opens up more research,” Thrasher told Endocrine Today. “This is a really interesting group to study. It’s not really been done very much with diabetes drugs, but it’s been done with other drugs such as cardiovascular and hypertension drugs.”
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which does not require dose adjustments despite renal function or hepatic impairment. However, it has not been studied as an adjunct to insulin treatment and is not indicated for use in type 1 diabetes or those experiencing ketoacidosis.
“We found that this drug had clinically significant and clinically relevant reductions in all measured hyperglycemia,” Thrasher concluded. –Samantha Costa
Disclosure: Dr. Thrasher reports research funding from Boehringer Ingelheim and Eli Lilly and Company, and speaker honorarium from both companies.