In a nutshell
This study compared the efficacy and safety of once-daily insulin degludec (Tresiba), following a rigid or flexible schedule, to once-daily insulin glargine (Lantus).
Type 2 diabetes affects millions of patients worldwide, many of whom require daily insulin injections to achieve optimal glycemic control. Long-acting insulins are often used to provide stable blood insulin levels throughout the day. These are often referred to as basal insulin injections. Achieving stable insulin levels is crucial in preventing common complications such as hypoglycemia (dangerously low blood glucose levels) and hyperglycemia (high blood glucose levels which contribute to organ damage). This requires basal insulin injections to be administered following a ridged schedule, which may interfere with daily activities. Insulin degludec, an ultra-long acting insulin, was recently developed and is currently under investigation. Ultra-long acting insulins have the potential to reduce the amount of injections needed to achieve stable glycemic control, and may allow for more flexibility regarding injection schedules.
Methods & findings
This trial included 610 patients diagnosed with type 2 diabetes. Patients were randomized into three groups. 229 patients were assigned to a once-daily insulin degludec regimen, received at flexible times of day with intervals of 8 to 40 hours in between doses. 228 patients were assigned to a once-daily insulin degludec regimen, received each day at a constant time, and 230 patients were assigned to a once-daily insulin glargine (a commonly used basal insulin) regimen, received each day at a constant time. Changes in HbA1c levels (a measurement of average blood glucose levels over the past 3 months) were compared between treatment groups after 26 weeks of therapy.
A flexible once-daily insulin degludec regimen was found to improve HbA1c levels by an average of 1.28%. In comparison, a non-flexible once-daily insulin degludec regimen was found to improve HbA1c levels by an average of 1.07% and a non-flexible once-daily insulin glargine regimen was found to improve HbA1c levels by an average of 1.26%. 38.9% of patients on the flexible once-daily insulin degludec regimen and 43.9% of patients receiving insulin glargine achieved the recommended HbA1c target levels of less than 7%. The rate of patient reported hypoglycemic events was similar among all three treatment groups, with severe hypoglycemia being rare.
The bottom line
This study concluded that insulin degludec appears both effective and safe in the treatment of type 2 diabetes, even when administered at variable intervals.
Published By :
Apr 01, 2013
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