Open AccessInsulin degludec compared with insulin glargine in insulin‐naïve patients with type 2 diabetes: A 26‐week, randomized, controlled, P an‐ A sian, treat‐to‐target trial
Author(s) -
Onishi Yukiko,
Iwamoto Yasuhiko,
Yoo Soon Jib,
Clauson Per,
Tamer Søren C,
Park Sungwoo
Publication year - 2013
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12102
Subject(s) - medicine , insulin glargine , insulin degludec , hypoglycemia , insulin , confidence interval , glycated hemoglobin , diabetes mellitus , randomized controlled trial , glycemic , type 2 diabetes , endocrinology , gastroenterology
Insulin degludec ( ID eg) is an ultra‐long‐acting basal insulin with a consistent action profile of >42 h. This trial compared the efficacy and safety of ID eg with insulin glargine ( IG lar) in insulin‐naïve A sian patients with type 2 diabetes. Materials and Methods In this multinational, 26‐week, open‐label, treat‐to‐target trial, 435 participants (202 females, 233 males; mean age 58.6 years; mean body mass index 25 kg/m 2 ; mean glycated hemoglobin [ H b A 1c ] 8.5%) were randomized (2:1) to ID eg or IG lar, each administered once daily with ≥1 oral antidiabetic drug(s) ( OAD ). Results After 26 weeks, H b A 1c had decreased by 1.24 and 1.35% in the ID eg and IG lar groups, respectively (treatment difference [ ID eg – IG lar] 0.11%, 95% confidence interval [ CI ] −0.03 to 0.24), confirming non‐inferiority. Rates of overall confirmed hypoglycemia were similar for ID eg and IG lar during the full trial period (3.0 vs 3.7 episodes/patient‐year of exposure [ PYE ]; rate ratio [ RR ] 0.82, 95% CI 0.60 to 1.11, P = 0.20), but significantly lower (by 37%) for ID eg during the maintenance period (from week 16 onward; RR 0.63, 95% CI 0.42 to 0.94, P = 0.02). No significant difference in the rate of nocturnal confirmed hypoglycemia was found between ID eg and IG lar in the full trial period (0.8 vs 1.2 episodes/ PYE ; RR 0.62, 95% CI 0.38 to 1.04, P = 0.07) or maintenance period ( RR 0.52, 95% CI 0.27 to 1.00, P = 0.05). Adverse event rates were similar between treatments. Conclusions Initiating insulin therapy with ID eg in A sian patients with type 2 diabetes, inadequately controlled with OAD s, provides similar improvements in long‐term glycemic control to IG lar, but at a significantly lower rate of overall confirmed hypoglycemia once stable glycemic control and insulin dosing are achieved. This trial was registered with www.clinicaltrials.gov (no. NCT 01059799).