Linagliptin, the type 2 diabetes (T2D) treatment co-marketed by Eli Lilly and Boehringer Ingelheim, delivered promising Phase III results, significantly reducing the level of blood glucose in elderly patients with the disease who were treated with the drug for 24 weeks compared with placebo, according to a study published yesterday in The Lancet.
Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor marketed under the names Tradjenta® in the United States and Trajenta® overseas, also showed a safety and tolerability profile similar to that of placebo, according to the study.
The late-stage study examined linagliptin in 241 seniors aged 70 or older with T2D. Of these patients, 162 were randomized to receive linagliptin 5 mg and the remaining 79 to receive placebo, in addition to existing glucose-lowering drugs such as metformin and/or sulfonylurea and/or basal insulin. The 24-week study was conducted at a total 33 centers in Australia, Canada, Denmark, the Netherlands, and Sweden.
The primary endpoint for the study was change in HbA1c from baseline to week 24. Key results from the study showed that the mean change from baseline in HbA1c with linagliptin was –0.64% after 24 weeks, compared with a mean 0.04% HbA1C increase for placebo. A secondary endpoint, placebo-adjusted mean reduction in fasting plasma glucose from baseline with linagliptin, was –20.7 mg/dL.
Both treatment arms saw the same percentage (75.9%) of people with any adverse event. Common adverse events included hypoglycemia (22.8% for linagliptin, 16.5% placebo); common cold (10.5% linagliptin, 8.9% placebo), diarrhea (5.6% linagliptin, 2.5% placebo), hyperglycemia (5.6% linagliptin, 10.1% placebo), back pain (7% linagliptin), falls (4.3% linagliptin, 2.5% placebo), and urinary tract infection (4.3% linagliptin, 6.3% placebo). One patient per group had a drug-related adverse event leading to discontinuation of the study.
Investigator-defined hypoglycemia occurred in 24.1% of the linagliptin group, and 16.5% of the placebo group.
Linagliptin, a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with T2D, won FDA approval in 2011, followed last year by agency approval of a combination treatment of linagliptin and metformin. Boehringer Ingelheim on Wednesday reported Trajenta sales of €200 million ($267.30 million) during the first half of this year, despite it not being available in Germany, where regulators have attributed no additional benefit to the drug.