Insulin degludec is a novel formulation with 200units/ml that has shown non-inferiority to Lantus in terms of efficacy and safety but requires less volume when dosing….
The new basal insulin formulation, insulin degludec contains the same amount of units of insulin in half the volume of traditional basal insulin formulations. Marketed under the brand Tresiba® in the UK, Insulin degludec contains 200 units/ml of insulin in contrast to the other formulations of 100units/ml. Dr. Stephen C.L. Goug and colleagues conducted a study to determine the efficacy and safety of insulin degludec 200 units/mL once daily with 100 units/mL insulin glargine (Lantus®) in insulin-naïve patients with type 2 diabetes who have inadequate glucose control with oral antidiabetic drugs.
The study was a 26-week, randomized, controlled, multinational, treat-to-target trial of 457 patients with a mean HbA1c of 8.3%; BMI of 32.4 kg/m2, and fasting plasma glucose of 173.2 mg/dL. Patients were openly randomized to receive either insulin degludec or insulin glargine, both given once daily in combination with metformin with or without a DPP-4 inhibitor. In each group, the basal insulins were initiated at 10 units daily followed by weekly titrations to achieve a fasting blood glucose <90 mg/dL.
After the 26 week study period, the authors reported a mean reduction of HbA1c of 1.3% in the insulin degludec treatment arm. This reduction was not inferior to that seen by the use of insulin glargine. The authors did observe a significant reduction of mean fasting blood glucose levels with the use of degludec 200unit/ml formulation compared to insulin glargine. Even with the increased fasting glucose reduction, rates of hypoglycemia were not significantly different with use of degludec 200units/ml than with the use of 100unit/ml glargine. The average daily dose of basal insulin required, was reported to be 11% lower with insulin degludec compared to insulin glargine. Insulin degludec was reported to be well tolerated by patients and the number of adverse effects requiring emergency treatment was similar to the rate seen with insulin glargine.
Goug and colleagues concluded that in patient with type 2 diabetes naive to insulin therapy, insulin degludec 200units/ml improved glucose control similarly to insulin glargine 100units/ml, with a low risk for hypoglycemia.
Gough, SC., Bhargav, A., Jain, R., et al. "Low-Volume Insulin Degludec 200 units/mL Once Daily Improves Glycemic Control Similar to Insulin Glargine With a Low Risk of Hypoglycemia in Insulin-Naïve Patients With Type 2 Diabetes: A 26-week, randomized, controlled, multinational, treat-to-target trial: The BEGIN LOW VOLUME trial." Diabetes Care. May 28, 2013. doi: 10.2337/dc12-2329
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