Introduction: Many type 2 diabetes patients continue to have poor glycaemic control and would benefit from insulin therapy. One of the risks that hinders insulin use is hypoglycemia. Optimal insulin therapy should therefore minimize the risk of hypoglycemia while improving glycemic control. Newer insulin preparations degludec and glargin 300 units/ml show more even and prolonged pharmacokinetic profile, enabling an evenly distributed daytime glucose-lowering effect with high reproducibility of action.
Aims: The aim of the study was to compare efficacy and safety of the insulin degludec with glargin 300 units/ml in insulin-naive subjects with type 2 diabetes.
Patients and methods: In this 24-week, parallel-group, randomized, open-label, treat-to-target-trial, adults with type 2 diabetes with A1c >7% taking oral antidiabetic drugs (OADs) were randomized 1:1 to receive once daily degludec or glargin 300 units/ml, both with metformin. At randomisation, eligible participants discontinued all OADs (DPP-IV inhibitors, sulfonylureas, pioglitazone) with the exception of metformin. Degludec and glargin 300 units/ml were administered in the morning with breakfast. Insulin was titrated to achieve prebreakfast plasma glucose (PG) of 3.94.9 mmol/l. In order to control postprandial glycemia, DPP-IV inhibitors or repaglinide were introduced as needed.
Results: Study included 184 participants (mean age 68.5±8.5 years, mean duration of diabetes 12.0±4.7 years, mean BMI 27.2±2.6 kg/m2, mean baseline A1c 9.5±1.4%) that were randomized (degludec 92, glargin 300 units/ml 92). Reduction in A1c with degludec was similar to that with glargin 300 units/ml (2.2% vs 2.3%, P=0.7). Overall rates of confirmed hypoglycemia (PG<3.9 mmol/l) were similar with degludec and glargine 300 units/ml (0.8 vs 0.9 episodes/patient-year). None of enrolled patients had severe or nocturnal hypoglycemia. End-of-trial mean daily insulin doses were 0.35 units/kg and 0.39 units/kg for degludec and glargine 300 units/ml, respectively, which was significant difference (P=0.02). Increase in body weight was observed: 1.8 kg and 1.5 kg for degludec and glargine 300 units/ml, respectively (P=0.6).
Conclusion: Despite the well-documented benefits of timely blood glucose control and the availability of consensus guidelines encouraging the earlier use of insulin replacement, a substantial delay remains with respect to the appropriate initiation of insulin treatment in routine clinical practice. BOT with both insulin degludec and glargine 300 units/ml are useful strategies that improve glycemic control in clinical practice without causing serious hypoglycemia.
19 - 22 May 2018
European Society of Endocrinology