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- Title
Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial.
- Authors
Onishi, Y.; Ono, Y.; Rabøl, R.; Endahl, L.; Nakamura, S.
- Abstract
Aims This phase 3, 26-week, open-label, treat-to-target trial investigated the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in insulin-naïve Japanese adults with type 2 diabetes. Methods Subjects were randomized to once-daily injections of IDegAsp (n = 147) or insulin glargine (IGlar) (n = 149), both ±≤2 oral antidiabetic treatments. IDegAsp was given before the largest meal at the discretion of each subject (and maintained throughout the trial); IGlar was dosed according to label. Both insulins were titrated to a target prebreakfast self-measured plasma glucose of 3.9 to <5.0 mmol/l. Results After 26 weeks, mean HbA1c was 7% with IDegAsp and 7.3% with IGlar; superiority of IDegAsp to IGlar was shown (estimated treatment difference, ETD; IDegAsp-IGlar: -0.28% points [−0.46; -0.10]95% CI, p < 0.01). At end-of-trial, mean fasting plasma glucose ( FPG) was similar for IDegAsp and IGlar (5.7 vs. 5.6 mmol/l; ETD IDegAsp-IGlar: 0.15 mmol/l [−0.29; 0.60]95% CI, p = NS). IDegAsp was associated with numerically lower rates of overall confirmed (27%) and nocturnal confirmed hypoglycaemia (25%) versus IGlar (estimated rate ratio IDegAsp/IGlar: 0.73 [0.50; 1.08]95% CI, p = NS, and 0.75 [0.34; 1.64]95% CI, p = NS, respectively). Mean daily insulin doses were similar between groups at end-of-trial (both: 0.41 U/kg) as were the increases in body weight from baseline (both: 0.7 kg). Adverse event profiles were similar between groups. Conclusions IDegAsp provided superior long-term glycaemic control compared to IGlar, with similar FPG and doses and numerically lower rates of overall and nocturnal hypoglycaemia (p = NS).
- Subjects
PEOPLE with diabetes; JAPANESE people; RANDOMIZED controlled trials; BODY weight; TYPE 1 diabetes; HYPOGLYCEMIA treatment; HEALTH
- Publication
Diabetes, Obesity & Metabolism, 2013, Vol 15, Issue 9, p826
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12097