Eli Lilly, Boehringer Ingelheim's Tradjenta meets main goal of Phase III study

In late-stage study data presented Thursday at the American Association of Clinical Endocrinologists annual meeting, Eli Lilly and Boehringer Ingelheim announced that the once-daily drug Tradjenta (linagliptin) significantly reduced HbA1c levels in African American adults with type 2 diabetes. The drugmakers noted this is the first published trial of a DPP-4 inhibitor specifically conducted in this population.

In the 24-week trial, 226 patients with type 2 diabetes whose blood glucose was inadequately controlled were randomly assigned treatment with either Tradjenta or placebo. HbA1c levels were measured at baseline and every six weeks throughout the course of the study. Results showed that the difference between the groups became significant by six weeks and remained so throughout the study. Specifically, Tradjenta resulted in a reduction of 0.88 percent in HbA1c levels, versus 0.24 percent in the placebo group, the companies said.

Regarding the trial's secondary endpoints, data demonstrated that patients in the Tradjenta group were significantly more likely to reach an HbA1c level of less than 7.0 percent at week 24, with 28 percent reaching the target value, compared with 8.7 percent for those on placebo. Patients in the Tradjenta group were also significantly more likely to see an HbA1c reduction of at least 0.5 percent during the same time period, the companies said.

Lead investigator James Thrasher commented that "as there may be differences in response to treatment among ethnic groups, an important finding of this trial is that the results are consistent with the A1c reduction seen in the [Tradjenta] pivotal trials, which included a small sample of African American patients."

Tradjenta was approved in the US last year to improve glycaemic control in adults with type 2 diabetes.

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