Insulin Degludec Versus Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes

Abstract

OBJECTIVETo compare ultra-long-acting insulin degludec with glargine for efficacy and safety in insulin-naive patients with type 2 diabetes inadequately controlled with oral antidiabetic drugs (OADs).RESEARCH DESIGN AND METHODSIn this 1-year, parallel-group, randomized, open-label, treat-to-target trial, adults with type 2 diabetes with A1C of 7−10% taking OADs were randomized 3:1 to receive once daily degludec or glargine, both with metformin. Insulin was titrated to achieve prebreakfast plasma glucose (PG) of 3.9−4.9 mmol/L. The primary end point was confirmation of noninferiority of degludec to glargine in A1C reduction after 52 weeks in an intent-to-treat analysis.RESULTSIn all, 1,030 participants (mean age 59 years; baseline A1C 8.2%) were randomized (degludec 773, glargine 257). Reduction in A1C with degludec was similar (noninferior) to that with glargine (1.06 vs. 1.19%), with an estimated treatment difference of degludec to glargine of 0.09% (95% CI −0.04 to 0.22). Overall rates of confirmed hypoglycemia (PG <3.1 mmol/L or severe episodes requiring assistance) were similar, with degludec and glargine at 1.52 versus 1.85 episodes/patient-year of exposure (PYE). There were few episodes of nocturnal confirmed hypoglycemia in the overall population, and these occurred at a lower rate with degludec versus glargine (0.25 vs. 0.39 episodes/PYE; P = 0.038). Similar percentages of patients in both groups achieved A1C levels <7% without hypoglycemia. End-of-trial mean daily insulin doses were 0.59 and 0.60 units/kg for degludec and glargine, respectively. Adverse event rates were similar.CONCLUSIONSInsulins degludec and glargine administered once daily in combination with OADs provided similar long-term glycemic control in insulin-naive patients with type 2 diabetes, with lower rates of nocturnal hypoglycemia with degludec.

New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Oral Agents and Basal Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION 2)

“…Differences of study design and populations preclude direct comparison of the present findings with other studies of longer-acting insulin. Nevertheless, these data resemble reported differences in hypoglycemia between degludec and glargine 100 units/mL (14) and those comparing PEGylated insulin lispro (LY2605541) and glargine 100 units/mL (15). Despite differences in treatment regimens, the results of EDITION 1 (basal and mealtime insulin) and EDITION 2 (basal insulin plus OADs) were consistent.…”

Efficacy and safety of insulin degludec in Japanese patients with type 1 and type 2 diabetes: 24‐week results from the observational study in routine clinical practice

“…In the treat‐to‐target study of degludec and glargine in insulin therapy‐naïve patients (with basal supported oral therapy), degludec allowed glycemic control, with a lower frequency of nocturnal hypoglycemia compared with glargine20, 21. In the present study, the frequency of hypoglycemia in the type 2 group was low before switching, and no significant change was detected after switching.…”

Weight‐sparing effect of insulin detemir: a consequence of central nervous system‐mediated reduced energy intake?

“…Furthermore, in children and adolescents with T1D, the use of insulin detemir did not appear to be associated with adverse weight gain when compared with NPH insulin 12, 13. The proposal that weight‐sparing is a novel intrinsic pharmacological property of insulin detemir is supported by the observation that other analogues, including insulin glargine and insulin degludec, do not exhibit this property in clinical trials 14.…”