Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company has presented the data from three pooled analyses for linagliptin at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin. The new analyses show linagliptin, alone or in combination with other diabetes therapies, lowered hemoglobin A1c (HbA1c or A1C) in elderly patients with type 2 diabetes, as well as in adults with type 2 diabetes with diabetic nephropathy (renal disease).

Data from a fourth study found adding linagliptin to a stable dose of basal insulin improved blood glucose control over 52 weeks without an additional risk of hypoglycemia or weight gain compared to placebo.

Linagliptin, marketed in the US as Tradjenta, is a once-daily tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).

"We are committed to developing and providing therapeutic solutions, such as linagliptin, for adult patients with type 2 diabetes," said Christophe Arbet-Engels, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim. "We look forward to continuing our ongoing clinical trial programme to assess how linagliptin may address the various needs of these patients."

An analysis of data pooled from seven phase III trials among 1,331 patients showed linagliptin, used alone or as add-on to various glucose-lowering therapies, had a placebo-adjusted reduction in A1C of 0.62 per cent from a baseline A1C of 8.0 per cent at 24 weeks in elderly patients (> 65 years) with type 2 diabetes. A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. These patients also experienced a placebo-adjusted reduction in fasting plasma glucose (FPG) of 14.8 mg/dL.

Adverse events (AEs) were experienced by 71.3 per cent and 73.3 per cent of patients who received linagliptin and placebo, respectively, and drug-related AEs were reported in 18.1 per cent of patients treated with linagliptin compared with 19.8 per cent of patients treated with placebo. The incidence of hypoglycemia was 21.4 per cent in patients who received linagliptin compared with 25.7 per cent in patients who received placebo. Severe hypoglycemic events requiring assistance were reported in both groups (1.0 per cent and 1.8 per cent, respectively). Overall AE reporting for GI disorders was comparable between both groups (14.1 per cent and 15.5 per cent, respectively).


"Many patients are found to have diabetic nephropathy after diagnosis with type 2 diabetes," said Lance A Sloan, president and CEO, Texas Institute for Kidney and Endocrine Disorders. "Unfortunately, as kidney function declines, treatment choices for patients become more complex and limited. At this point, patients require additional monitoring to maintain optimal dosing and efficacy."

In a third abstract, patients with type 2 diabetes treated with linagliptin in combination with a stable dose of basal insulin showed a placebo-adjusted reduction in A1C of 0.53 percent from baseline after 52 weeks (n=1,261). This was accompanied by a mean change in basal insulin dose of +2.6 +/- 0.8 IU/day for linagliptin plus basal insulin vs. +4.2 +/- 0.8 IU/day for placebo plus basal insulin. The incidence of hypoglycemia was similar between the groups (linagliptin, 31.4%; placebo, 32.9%), as was the number of severe hypoglycemic events over one year (linagliptin, 1.7%; placebo, 1.1%). In addition, the average changes in body weight were comparable between the treatment groups (linagliptin, -0.30 +/- 3.7kg; placebo, -0.04 +/- 3.1kg).

In a fourth abstract (poster #848), linagliptin as add-on to basal insulin therapy vs. placebo also was studied in elderly patients ( > 70 years) in a separate pre-specified pooled analysis of two Phase III studies over 24 weeks (poster #848). Linagliptin achieved improvements in glycemic control of -0.77% (placebo-adjusted change in A1C from baseline [P < 0.0001]), with a rate of hypoglycemia of 28.6% in linagliptin-treated patients and 37.2% in placebo-treated patients. In this population, the overall incidence of AEs for linagliptin in combination with basal insulin was not higher than placebo (75.4% and 81.0%, respectively).