In a nutshell
This study evaluated the safety and effectiveness of once-daily insulin detemir and insulin glargine when added to metformin therapy in type 2 diabetes patients.
Some background
Initiating insulin therapy with a once-daily basal insulin therapy (long-acting insulins used to provide stable blood insulin levels throughout the day) in patients with type 2 diabetes is a simple and well-tolerated treatment strategy. Additionally, patients can successfully and safely self-titrate these basal insulins towards appropriate fasting plasma glucose targets.
The relatively long duration of action of detemir (Levemir) and glargine (Lantus) allows them to be used once daily in the majority of patients with type 2 diabetes. This study was designed to compare the effectiveness and tolerability of detemir and glargine using equal once daily dosing regimens with a target fasting plasma glucose level of 90 mg/dL.
Methods & findings
This study evaluated the effectiveness and safety of adding detemir or glargine to metformin (Glucophage) therapy in insulin-naïve type 2 diabetes patients whose disease was not adequately controlled. 226 patients were randomized to receive detemir while 227 were randomized to receive glargine. Both insulins were administered once daily anytime in the evening from 1 hour before the last main meal until bedtime. Patients were followed for 26 weeks.
At the end of the study, the average reduction in HbA1c level (a measurement of average blood glucose levels over the past 3 months) for detemir was 0.48% to an end HbA1c level of 7.48%. The average reduction in HbA1c level for glargine was 0.74% to an end HbA1c level of 7.13%.
The proportions of patients reaching HbA1c levels of 7% or less at 26 weeks were 38% in the detemir group and 53% in the glargine group. HbA1c levels of 6.5% or less were achieved by 11% of the detemir group and 21% of the glargine group. Attainment of HbA1c levels of 6.5% or less without hypoglycemic episodes was achieved by 8.6% of the detemir group and 15.2% of the glargine group.
Average fasting plasma glucose levels decreased by 44.8 mg/dL to 112 mg/dL in the detemir group. Average levels decreased by 43.4 mg/dL to 109.6 mg/dL in the glargine group. These differences were not deemed to be statistically significant.
The overall rate of hypoglycemia (dangerously low glucose levels) was low for both treatments. The rate of hypoglycemia was 27% lower in the detemir group than the glargine group. Those in the detemir group lost an average of 0.49 kg while those in the glargine arm put on an average of 1 kg, giving a significant weight advantage to detemir. 64.2% of those taking detemir reported adverse events compared to 61.7% of those taking glargine. These were predominantly injection-site reactions.
The bottom line
While both detemir and glargine, when added to metformin therapy, improved glycemic control, glargine resulted in greater reductions in HbA1c, while detemir demonstrated less weight gain and hypoglycaemia.
Published By :
Diabetes, Obesity and Metabolism
Date :
Aug 13, 2013