Eli Lilly (LLY) and partner Boehringer Ingelheim Pharmaceuticals announced on Thursday positive results for a late-stage study of an experimental treatment for type 2 diabetes in black and African American adult patients.
The once-daily tablet, marketed as Tradjenta, showed significant hemoglobin reduction of 0.88% compared with 0.24% in the placebo group at 24 weeks in patients whose blood sugar had not previously been adequately controlled, Lilly said.
The study proved the efficacy and safety profile of the drug, known experimentally as linagliptin.
The drug is intended to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus. The treatment, unlike some of its competitors, doesn’t require adjustments to dosage regardless of declining renal function or hepatic impairment, Lilly said.
The published trial marks the first of so-called DPP-4 inhibitors conducted specifically on black and African American adult type-2 patients.
“In the U.S., African Americans and other ethnic minorities are significantly unrepresented in clinical trials,” Lilly said in a statement.
In the U.S., the risk of diabetes is 77% greater for non-Hispanic black adults, when compared with non-Hispanic white adults, with an estimated 18.7%, about 4.9 million of all non-Hispanic black adults living with the disease, according to Lilly.
The 24-week study was conducted using 226 patients who all received at least one dose of the study drug. Adverse effects, such as high blood sugar levels, were consistent with the placebo.
In a statement, Dr. John Smith, senior vice president for clinical development and medical affairs at Boehringer Ingelheim, said the study suggests that the drug can provide black and African American adult patients with “another option to improve control of their blood sugar.”