title: Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes.
abstract: This trial compared the efficacy and safety of basal-bolus therapy using either the soluble basal insulin analogue insulin detemir (IDet) in combination with meal-time rapid-acting analogue insulin aspart (IAsp), or NPH insulin (NPH) in combination with meal-time regular human insulin (HSI). This was a 22-week, multinational, open-labelled, symmetrically randomised, parallel group trial including 395 people with type 2 diabetes (IDet + IAsp: 195, NPH + HSI: 200). At 22 weeks, HbA1c was comparable between treatments (IDet + IAsp: 7.46%, NPH + HSI: 7.52%, P = 0.515) with decreases from baseline of 0.65% and 0.58%, respectively. Treatment with IDet + IAsp was associated with a significantly lower within-person variation in self-measured fasting plasma glucose (FPG) (SD:1.20 versus 1.54 mmol/L, p < 0.001), as well as a lower body weight gain (0.51 versus 1.13 kg, p = 0.038) than with NPH + HSI. The risk of nocturnal hypoglycaemia was 38% lower with IDet + IAsp than with NPH + HSI, but statistical significance was not attained (P = 0.14). The overall safety profile was similar between the two treatments. Basal-bolus treatment with IDet + IAsp is an effective and well tolerated insulin regimen in people with type 2 diabetes, resulting in glycaemic control comparable to that of NPH + HSI, but with the advantages of less weight gain and a lower day-to-day within-person variation in FPG.
authors.affiliation: Metabolic Center, Institute of Preventive and Clinical Medicine, Limbova 14, 833 01 Bratislava, Slovak Republic. katarina.raslova@nextra.sk
authors.forename: K
authors.initials: K
authors.lastname: Raslová
authors.forename: M
authors.initials: M
authors.lastname: Bogoev
authors.forename: I
authors.initials: I
authors.lastname: Raz
authors.forename: G
authors.initials: G
authors.lastname: Leth
authors.forename: M-A
authors.initials: MA
authors.lastname: Gall
authors.forename: N
authors.initials: N
authors.lastname: Hâncu
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight / Q000187:drug effects; D002940:Circadian Rhythm; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005215:Fasting / Q000097:blood; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000819:agonists / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061267:Insulin Aspart; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting; D008297:Male
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D049528:Insulin, Long-Acting; D000069057:Insulin Detemir; D061267:Insulin Aspart