Low-Volume Insulin Degludec 200 Units/mL Once Daily Improves Glycemic Control Similarly to Insulin Glargine With a Low Risk of Hypoglycemia in Insulin-Naïve Patients With Type 2 Diabetes

Abstract

OBJECTIVE The 200 units/mL formulation of insulin degludec (IDeg 200 units/mL) con- tains equal units of insulin in half the volume compared with the 100 units/mL formulation. We compared the efficacy and safety of IDeg 200 units/mL once daily with 100 units/mL insulin glargine (IGlar) in insulin-naïve subjects with type 2 diabetes (T2DM) inadequately controlled with oral antidiabetic drugs. RESEARCH DESIGN AND METHODS In this 26-week, open-label, treat-to-target trial, subjects (n =457;meanHbA1c 8.3% [67 mmol/mol], BMI 32.4 kg/m2, and fasting plasma glucose [FPG] 9.6mmol/L [173.2mg/dL]) were randomized to IDeg 200 units/mLor IGlar, both given once daily in combination with metformin with or without a dipeptidyl peptidase-4 in- hibitor. Basal insulin was initiated at 10 units/day and titrated weekly to an FPG target of ,5 mmol/L (,90 mg/dL) according to mean prebreakfast self-measured blood glucose values from the preceding 3 days. RESULTS By 26 weeks, IDeg reduced HbA1c by 1.30% and was not inferior to IGlar. Mean observed FPG reductions were significantly greater with IDeg than IGlar (23.7 vs.23.4mmol/L [–67 vs. –61 mg/dL]; estimated treatment difference: 20.42 [95% CI 20.78 to 20.06], P = 0.02). Despite this difference, rates of overall confirmed hypoglycemiawere not higherwith IDeg than with IGlar (1.22 and 1.42 episodes/patient-year, respectively), as were rates of nocturnal confirmed hypoglycemia (0.18 and 0.28 episodes/patient-year, respectively). Mean daily basal insulin dose was significantly lower by 11% with IDeg 200 units/mL compared with IGlar. IDeg was well-tolerated, and the rate of treatment-emergent adverse events was similar across groups. CONCLUSIONS In this treat-to-target trial in insulin-naïve patients with T2DM, IDeg 200 units/mL improved glycemic control similarly to IGlar with a low risk of hypoglycemia.