Evaluating the efficacy of linagliptin in patients with poorly controlled type 2 diabetes mellitus

This study assessed the efficacy and safety of linagliptin (Tradjenta) for the treatment of patients with uncontrolled type 2 diabetes mellitus (T2DM).

Patients with T2DM have high blood glucose levels (hyperglycemia) caused by insulin resistance (the cells of the body fail to respond to the normal actions of the hormone insulin) or by insufficient release of insulin from the pancreas. Insulin is a hormone produced by the pancreas that lowers blood glucose after meals. The pancreas also produces the hormone glucagon that has an opposite effect to that of insulin by increasing blood glucose levels. Linagliptin is a drug approved by the U.S. FDA for the treatment of patients with T2DM that works by increasing insulin release from the pancreas and also by reducing glucagon secretion. Linagliptin can be used as a single drug (monotherapy) for the treatment of T2DM or can be added to other drugs such as metformin (Glucophage) and sulfonylureas (a class of glucose lowering drugs), depending of the patients’ blood glucose levels and how they respond to therapy. The purpose of this study was to evaluate the safety and efficacy of linagliptin in patients with uncontrolled T2DM. 

This study included 396 patients with uncontrolled T2DM. 81 patients were randomly assigned to receive linagliptin alone, 127 received linagliptin and metformin, while 188 patients were treated with linagliptin added to metformin plus sulfonylurea. However, only 388 patients completed the 24-week treatment period and were included in the analysis. Of these, 287 patients received the actual linagliptin, while 101 patients received a placebo (a substance with no medical effect used as a control when testing new drugs). Efficacy was measured through the value of the glycated hemoglobin or HbA1c (a test that measures an average of blood glucose levels from the last 2 to 3 months). All patients included in the study had an HbA1c level of 9.0% or higher. 

After 24 weeks of treatment, the HbA1c levels were reduced from an average of 9.4% to 8.3% in patients treated with linagliptin and to 9.1% in patients treated with placebo. For patients in the monotherapy group, linagliptin reduced HbA1c by 0.9% compared to a 0.2% increase in patients who received placebo. In patients with add-on metformin, linagliptin resulted in a 0.9% reduction in HbA1c compared to a 0.3% reduction in patients receiving placebo. In the group treated with metformin and sulfonylurea, patients who received linagliptin had a 1.3% reduction in HbA1c levels compared to a 0.6% reduction in patients who received placebo. Side effects were similar in all treatment groups.

In summary, linagliptin was well tolerated and showed significant improvements in blood glucose control, both as monotherapy and as add-on to metformin and sulfonylurea in patients with poorly controlled T2DM. 

This study is limited by the short duration of the treatment period, as well as the small number of participants in each group. Larger studies are needed in order to confirm the findings of this research.

Ask your doctor whether linagliptin is a good treatment option in your situation.