Evaluating safety and efficacy of a new drug for patients with type 2 diabetes mellitus

This study assessed the efficacy and safety of adding gemigliptin versus sitagliptin to metformin treatment in patients with type 2 diabetes mellitus (T2DM).

T2DM is a condition in which patients have high blood glucose levels (hyperglycemia) when cells fail to respond to the normal actions of the hormone insulin or insulin is insufficiently produced by the pancreas. Metformin (Glucophage) is the most common drug used to treat patients with T2DM. However, sometimes metformin alone cannot effectively achieve glycaemic (blood glucose) control in T2DM patients. Therefore, other glucose lowering drugs are needed. A class of anti-diabetes drugs which effectively decreases blood glucose levels is dipeptidyl peptidase-4 inhibitors (DPP4). These drugs act by increasing insulin release from the pancreas, but also help reduce glucagon secretion. Glucagon is a hormone produced by the pancreas that increases blood glucose levels by making more glucose in the liver, thus opposing the effects of insulin. Sitagliptin (Januvia) is a DPP4 that has been approved by the U.S. FDA (since 2006) for the treatment of T2DM patients. It can be used alone, or combined with metformin (Janumet). Gemigliptin (Zemiglo) is another DPP4 that has been approved by the Korean Food and Drugs Administration (KFDA) on June 27, 2012 as treatment for T2DM patients. However, it has not yet been approved by U.S. FDA. This phase III clinical trial compared the efficacy and safety of adding gemigliptin versus sitagliptin to metformin therapy in patients with T2DM.

This study involved 425 T2DM patients who had been treated with metformin alone. In addition to metformin, 142 patients were randomly assigned to receive sitagliptin 100mg once a day (group Sita), 142 received gemigliptin 50mg once a day (group Gemi50) and 141 received gemigliptin 25mg twice a day (group Gemi25). The efficacy of the treatment was measured through the value of the glycated hemoglobin or HbA1c (a blood test that measures the average of blood glucose control from the previous 2 to 3 months).

After 24 weeks of treatment, 20.74% of patients in Gemi50 group, 22.06% on Gemi25 group and 18.05% the Sita group achieved an HbA1c level of less than 6.5%. A good glycaemic control was also achieved in all groups regarding fasting and after meals blood glucose levels. Adverse effects (a harmful and undesired effect resulting from a medication) occurred in less than 10% of patients in each group.

In summary, this study showed that gemigliptin added to metformin is well tolerated and is as effective as sitagliptin in achieving glycaemic control in patients with T2DM.

This study was funded by LG Life Sciences Ltd, the manufacturer of gemigliptin.

Talk to your doctor regarding the most appropriate T2DM treatment for you.