Basal insulin combined with oral antihyperglycemic drugs is a reality for many patients with type 2 diabetes. Novel strategies for treatment and new doses of insulin are emerging, and researchers are seeking to gain more information to better treat their patients.
In a study published in Diabetes Care, researchers compared the safety and efficacy of new insulin glargine 300 U/L with insulin glargine 100 U/L in patients with type 2 diabetes using at least 40 U of basal insulin daily in addition to oral antihyperglycemic drugs.
The trial multicenter, open label study was dubbed EDITION 2.
Adult patients were randomly assigned to insulin glargine 300 U/L or insulin glargine 100 U/L once daily for 6 months. Researchers focused on change in HbA1c and percentage of patients with at least one nocturnal or severe hypoglycemic event from week 9 to 6 months.
Mean HbA1c was 8.24% and mean BMI was 34.8 for the 811 study participants. All experienced similar improvements in glycemic control with both insulins: mean reduction of –0.57% for insulin glargine 300 U/L and –0.56% for insulin glargine 100 U/L, with 10% higher dose of insulin glargine 300 U/L, according to the study results.
The researchers observed less nocturnal or severe hypoglycemia with insulin glargine 300 U/L (relative risk=0.77; 95% CI, 0.61-0.99) from week 9 to 6 months as well as during the first 8 weeks. Also, during the entire 6 months, fewer nocturnal and anytime hypoglycemic events were reported.
Less weight gain was found with insulin glargine 300 U/L, as compared with insulin glargine 100 U/L (P=.015).
The researchers also identified no between-treatment differences in safety.
They concluded that the higher dose of insulin glargine was on par with the lower dose in terms of efficacy but also carried a lower risk for hypoglycemia.
In the EDITION 2 trial published in Diabetes Care, researchers compared safety and efficacy of the new insulin glargine 300 U/L dose with the insulin glargine 100 U/L dose in patients with type 2 diabetes on insulin and taking oral diabetes medications.
Findings offer insight into the similarities between these treatments, thereby adding to the evidence base of whether the new dose will be an effective treatment.