Pooled Data Show Benefits of Linagliptin (Tradjenta) in African-American Adults With Type-2 Diabetes
Phase III trials compare linagliptan and placebo
Data from a retrospective pooled analysis of eight phase III trials of linagliptin (Tradjenta, Boehringer Ingelheim/Lilly) 5 mg once daily have shown reductions from baseline in hemoglobin A1c (HbA1c) at 18 (eight trials) and 24 (six trials) weeks compared with placebo in African-American adults with type-2 diabetes.
In addition, similar proportions of patients in the linagliptin and placebo groups experienced adverse events, including hypoglycemia.
The new data were presented at the 23rd Annual Scientific & Clinical Congress of the American Association of Clinical Endocrinologists, being held May 14–18 in Las Vegas.
According to the Centers for Disease Control and Prevention (CDC), African-Americans, along with other minority groups, are at a higher risk for type-2 diabetes than the rest of the population.
The retrospective pooled analysis from eight randomized, placebo-controlled phase III trials included 336 adults with type-2 diabetes in North and South America who self-reported their race as African-American. Of the participants, 173 received linagliptin 5 mg and 163 received placebo once-daily, either as monotherapy or as an add-on to various glucose-lowering regimens, for 18 weeks (two trials) or 24 weeks (six trials).
The primary efficacy endpoint was the change in HbA1c (a measure of average blood glucose) from baseline to 18 weeks or 24 weeks. Mean baseline HbA1c levels were 8.53% in the linagliptin group and 8.61% in the placebo group.
Safety was assessed according to the incidence and intensity of adverse events (AEs), including the incidence and intensity of hypoglycemia.
Key findings from the retrospective pooled analysis included the following:
- The placebo-adjusted mean changes in HbA1c levels from baseline with linagliptin were –0.69% at week 18 (eight trials) and –0.64% at week 24 (six trials).
- Similar proportions of patients in the linagliptin and placebo groups experienced AEs (65.3% vs. 68.1%, respectively), with a lower percentage of patients experiencing drug-related AEs in the linagliptin group compared with the placebo group (9.2% vs. 13.5%, respectively).
- The incidence of hypoglycemia was similar across treatment groups (12.1% for linagliptin and 11.7% for placebo).
Tradjenta (linagliptin) is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with type-2 diabetes. The drug should not be used in patients with type-1 diabetes or for the treatment of diabetic ketoacidosis. Linagliptin has not been studied in patients with a history of pancreatitis.
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2-diabetes. Type-2 diabetes is the most common form, accounting for an estimated 85% to 95% of all diabetes cases.
Source: Eli Lilly; May 15, 2014.