Health status and hypoglycaemia with insulin degludec versus insulin glargine: a 2-year trial in insulin-naïve patients with type 2 diabetes.
Insulin degludec (IDeg) is a new basal insulin with an ultra-long and stable glucose-lowering effect. We compared once-daily IDeg and insulin glargine (IGlar), both in combination with metformin ± dipeptidyl peptidase-4 inhibitors, in a 52-week, open-label, treat-to-target trial in patients with type 2 diabetes followed by a 52-week extension trial in which subjects [n = 725/1030 (70.4%)] maintained their initial randomised treatment. Health status was assessed at baseline and 105 weeks using the Short Form-36 (SF-36 v2) questionnaire. SF-36 scores were analysed (ITT population) using anova, with adjustments for covariates. At 105 weeks, the overall physical component score was significantly better with IDeg versus IGlar [treatment contrast (TC): 1.1 (0.1; 2.1)95% CI , p < 0.05]. This was largely because of significantly better physical functioning [TC: 1.1 (0.0; 2.3)95% CI , p < 0.05] and bodily pain sub-domain scores [TC: 1.5 (0.2; 2.9)95% CI , p < 0.05]. Improvements in health status with IDeg compared to IGlar were maintained after 2 years.
Endocrine and Metabolic Consultants, Rockville, MD, USA.
H W
HW
Rodbard
B
B
Cariou
B
B
Zinman
Y
Y
Handelsman
M L
ML
Wolden
A
A
Rana
C
C
Mathieu
D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006304:Health Status; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000009:adverse effects*; D049528:Insulin, Long-Acting / Q000008:administration & dosage / Q000009:adverse effects*; D008687:Metformin / Q000627:therapeutic use; D016896:Treatment Outcome
D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine; C571886:insulin degludec; D008687:Metformin
SF-36; hypoglycaemia; insulin degludec; patient-reported outcomes; quality of life; type 2 diabetes