The effect of an interleukin-1? inhibitor on glycemic control

This study evaluated the efficacy and safety of canakinumab on improving glucose control in metformin treated patients with type 2 diabetes.

Type II diabetes is a metabolic disease characterized by elevated blood sugar level (hyperglycemia) and low sensitivity to insulin (a hormone that reduces blood sugar levels). Metformin (Glucophage) is a very common treatment for diabetes that suppresses glucose production in the body in an attempt to achieve glycemic control (balanced blood sugar levels). Yet, glycemic control is suboptimal in a significant portion of diabetic patients receiving medical treatment. Glycemic control is assessed by the blood level of glycated hemoglobin (HbA1c; the percentage of the body’s oxygen carrying protein that is coated in blood) where higher levels indicate poorer blood glucose control.

As the disease progresses, there is a decrease in function of pancreatic beta cell (cells that produce insulin), which results in reduced insulin production. Interleukin 1β (IL-1β) is a substance produced by the body that mediates inflammatory processes, believed to carry an important role in pancreatic beta cell destruction in diabetic patients. Past trials have demonstrated that by blocking IL-1β, pancreatic beta-cell secretory function can be enhanced, potentially restoring HbA1c levels.

The aim of this study was to determine the optimal dose at which canakinumab (Ilaris; a drug that blocks IL-1β) will improve glycemic control in type II diabetic patients. 

The study included 551 type II diabetic patients aged 18–74 years receiving metformin treatment. Patients were randomized to receive either placebo (a substance with no medical effects used as a control when testing new drugs) or four different doses of canakinumab: 5 mg, 15 mg, 50 mg and 150 mg. Patients were treated over a period of four months.

Results showed that all canakinumab doses reduced HbA1c blood levels.  The largest decrease of HbA1c levels was in the 50 mg group where the HbA1c level dropped by 0.18% versus placebo. However, none of the decreases in HbA1c levels were deemed to be statistically significant.

There were no meaningful differences between the groups with respect to severe side effects. However, patients treated with canakinumab reported more cases of urinary tract infections, common cold and liver impairment than the placebo group.

Overall, canakinumab treatment resulted in a small improvement in glycemic control of patients with type II diabetes. For short term treatment, canakinumab appeared as a safe and well tolerated drug.

This trial was conducted over a short period of time, which precludes any possible late complications and side effect of the drug. In addition, the study was supported by Novartis Pharmaceuticals Corporation, the manufacturer of the drug.