A late-stage clinical trial shows the drug linagliptin, marketed by Boehringer Ingelheim and Eli Lilly and Company, helps elderly patients with type 2 diabetes lower their blood glucose levels. Researchers from Boehringer Ingelheim and University of Birmingham in the U.K. describe their findings online this week in the journal The Lancet (paid subscription required).
Linagliptin — marketed in Europe as the brand name Trajenta and in the U.S. as Tradjenta — is taken orally once a day and works by increasing natural substances in the body that lower blood glucose when it reaches elevated levels. The drug does not cure diabetes, nor is it prescribed for patients with type 1 diabetes.
The authors say elderly type 2 diabetes patients up to now are largely excluded from trials of glucose-lowering drugs. As a result, physicians are somewhat limited in making treatment decisions with patients in this age group.
The clinical trial took place at 33 sites in Australia, Canada, Denmark, The Netherland, and Sweden enrolling 241 patients age 70 and older with type 2 diabetes. About two-thirds of the patients, assigned randomly, received linagliptin while one-third of the group was given a placebo. All patients also were given one more more current glucose-lowering medications: metformin, sulphonylurea, or basal insulin.
The researchers tested patients for their glycated hemoglobin levels, a test for blood glucose abbreviated HbA1c, at the beginning of the trial and after 24 weeks. The results showed the patients given linagliptin recorded significantly lower blood glucose levels compared to the placebo group. Results from another measure, a fasting plasma glucose test, showed a similar pattern.
About three-quarters (76%) of the patients encountered adverse events during the trial, with identical percentages reported in the treatment and placebo groups. About 9 percent of the linagliptin patients reported serious adverse effects, compared to 6 percent of the placebo recipients, although none of these events were deemed a result of the drug. Hypoglycemia, or low blood glucose, was the most commonly reported adverse effect, but its occurrence did not differ between the linagliptin and placebo groups.
Boehringer Ingelheim and Eli Lilly formed a collaboration in January 2011 to develop and market four diabetes drugs, two from each company, in mid- to late-stage clinical development. Linagliptin is one of the drugs initially developed and contributed by Boehringer Ingelheim to the partnership.
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