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

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2013-09, Vol.15 (9), p.826-832
• Main Authors: Onishi, Y., Ono, Y., Rabøl, R., Endahl, L., Nakamura, S.
• Format: Article
• Language: English
• Subjects: Adult; Asian Continental Ancestry Group; Blood Glucose - metabolism; Body weight; Diabetes; diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - epidemiology; Drug Administration Schedule; Drug Combinations; Female; glycaemic control; Glycated Hemoglobin A - metabolism; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents - therapeutic use; Injections, Subcutaneous; Insulin; insulin analogues; Insulin Glargine; insulin therapy; Insulin, Long-Acting - therapeutic use; Male; Middle Aged; Oral administration; phase 3 study; Treatment Outcome
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.12097

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