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Tradjenta effective in African Americans with diabetes

Lilly and Boehringer aim to overcome underrepresentation of black population in clinical studies

Tradjenta - Eli Lilly, Boehringer Ingelheim

A phase III trial of Eli Lilly and Boehringer Ingelheim's Tradjenta has shown it is effective in controlling blood sugar in African Americans with type 2 diabetes.

This is the first time that a drug in the DPP-4 inhibitor class has been tested specifically in a black population, according to Lilly.

In the trial, Tradjenta (linagliptin) achieved a 0.88 per cent reduction in haemoglobin A1C levels - a marker for blood glucose control over time - compared to 0.24 per cent with placebo, which was a statistically significant improvement.

In the US, African Americans and other ethnic minorities are significantly underrepresented in clinical trials, according to a study published in 2007 by the Endocrine Society, which set up a task force with the aim of increasing minority participation in clinical research.

Racial differences are known to have an impact on the safety and efficacy of medicines, as witnessed by the approval of BiDil (isosorbide dinitrate and hydralazine) in 2005 specifically to treat African Americans with heart disease.

BiDil was developed by pharma company NitroMed, which had been on the verge of dropping the agent after disappointing results in phase II trials across an ethnically-diverse population, only to discover on subsequent analyses that it worked in black patients.

The drug was launched to great fanfare as the first ethnic-targeted medicine and tipped as a potential blockbuster, but sales were slow - in part because of debate about the validity of using race to guide therapy in a multicultural population in the absence of a genetic or other biomarker. NitroMed abandoned promotional efforts for BiDil in 2008 but it remains on the market.

According to the lead investigator in the Tradjenta study, James Thrasher of Arkansas Diabetes and Endocrinology Centre, there may be differences in response to treatment among ethnic groups in diabetes too.

"An important finding of this trial is that the results are consistent with the A1C reduction seen in the linagliptin pivotal trials, which included a small sample of African American patients," he noted.

The results are also important because African Americans have a 77 per cent higher risk of developing diabetes than non-Hispanic white adults, with around 19 per cent of them living with the disease. That equates to around 4.9m people in the US, says Lilly.

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

The drug is known as Trajenta in Europe.

25th May 2012

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