Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100) for 52 Weeks in Insulin-Naïve Patients with Type 2 Diabetes: A Randomized Controlled Trial

• Published in: PloS one Vol. 11; no. 10; p. e0163350
• Main Authors: Kumar, Ajay, Franek, Edward, Wise, Jonathan, Niemeyer, Marcus, Mersebach, Henriette, Simó, Rafael
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 01.10.2016; Public Library of Science (PLoS)
• Subjects: Adults; Biology and Life Sciences; Blood Glucose - metabolism; Body Weight - drug effects; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Diurnal; Drug Combinations; Drug dosages; Female; Glucose; Hemoglobin; Humans; Hypoglycemia; Insulin; Insulin Glargine - adverse effects; Insulin Glargine - therapeutic use; Insulin resistance; Insulin, Long-Acting - adverse effects; Insulin, Long-Acting - therapeutic use; Male; Medicine and Health Sciences; Middle Aged; Nocturnal; Patients; Physical Sciences; Randomization; Safety; Poland; United States > US; Spain; India
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0163350

The efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily (OD) compared with insulin glargine U100 (IGlar) OD over 52 weeks in insulin-naïve adults with type 2 diabetes mellitus (T2DM) was investigated. In this open-label, parallel-group treat-to-target trial, participants were randomized (1:1) to receive IDegAsp OD (breakfast, n = 266) or IGlar OD (as per label, n = 264). Participants then entered a 26-week extension phase (IDegAsp OD, n = 192; IGlar OD, n = 221). The primary endpoint was change from baseline to Week 26 in HbA1c. After 26 and 52 weeks, mean HbA1c decreased to similar levels in both groups. After 52 weeks, the mean estimated treatment difference was -0.08% (-0.26, 0.09 95%CI), confirming the non-inferiority of IDegAsp OD versus IGlar OD evaluated at Week 26. After 52 weeks, there was a similar reduction in mean fasting plasma glucose in both treatment groups. The rate of confirmed hypoglycemic episodes was 86% higher (p < 0.0001) whereas the rate of nocturnal hypoglycemia was 75% lower (p < 0.0001) for IDegAsp versus IGlar. Nocturnal-confirmed hypoglycemia was higher with IGlar whereas overall and diurnal hypoglycemia were higher with IDegAsp dosed at breakfast. These results highlight the importance of administration of IDegAsp with the main meal of the day, tailored to the individual patient's needs. ClinicalTrials.gov: NCT01045707 [core]) and NCT01169766 [ext].