A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing
New study further demonstrated the safety and efficacy of insulin Levemir (insulin detemir [rDNA origin] injection).
Patients with type 2 diabetes were able to adjust their own dosage of Levemir and achieve improvements in blood sugar, comparable to dosing adjusted by their primary care physician. This improvement in A1c levels was observed with minimal weight change and without increases in rates of hypoglycemia.(1) The data were presented at the 67th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, Illinois.
"The study is a testament to the safety of Levemir, as patients were able to adjust their basal insulin dose on their own and achieve the same level of glycemic control as when guided by their doctor, while reducing the risk of hypoglycemia," said Luigi Meneghini, MD, MBA, Associate Professor of Clinical Medicine and the Director of the Eleanor and Joseph Kosow Diabetes Treatment Center at the Diabetes Research Institute, Miami, FL. "Since having type 2 diabetes requires a great deal of self-management, these findings will help empower patients to work more closely as partners with their physician to take control of their insulin treatment. The potential of improved self- management is made possible by insulin analogs like Levemir, which provide effective basal insulin coverage, and, as shown in this study, the added benefit of minimal weight change."
The new data were obtained from the insulin detemir 303 Algorithm tested in a Randomized Clinical Trial: The US PREDICTIVE(TM) 303 Trial (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation), which included 5,604 patients. The data showed that patient self-adjustment of insulin treatment with Levemir was as safe and effective when compared to dosing that was adjusted by physicians according to standard-of-care. The patients who self- adjusted their dosage achieved a level of diabetes control that was comparable to that of patients receiving physician-driven adjustments. Minimal weight change was observed in both trial arms.(2)
The findings on weight gain are consistent with previous studies of Levemir, the first insulin to show less weight gain versus other basal insulins in 12 of 12 controlled clinical trials*.(3) Weight gain is a common side effect of insulin therapy, which is a concern given that 80 percent of people with type 2 diabetes are overweight or obese.
The new data presented at ADA were from a six-month analysis of 5,604 type 2 diabetes patients, in a mainly primary care settings, and predominantly treated with Levemir once-daily, as an add-on therapy to any other glucose- lowering regimens, or as replacement of a previous basal insulin. Patients were randomized to either the "303 Algorithm" [self adjusting their Levemir dose every three days based on fasting plasma glucose (FPG)] or "Standard-of- Care" (Levemir dose was physician-adjusted according to standard-of-care) treatment groups.
The study showed that the average A1c, an indicator of long-term blood glucose control, decreased from 8.5 percent at baseline to 7.9 percent at 26 weeks for the 303 Algorithm group, and from 8.5 percent to 8.0 for Standard- of-Care group (p=0.001). Compared to baseline, FPG values decreased by 34 and 21 mg/dL for 303 Algorithm and Standard-of-Care groups, respectively (p<0.0001).
At 26 weeks, 88 percent of all patients remained on once-daily Levemir therapy. In a subset of insulin-na