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Intensifying insulin regimen after basal insulin optimization in adults with type 2 diabetes: a 24‐week, randomized, open‐label trial comparing insulin glargine plus insulin glulisine with biphasic insulin aspart ( L anScape)
Author(s) -
Vora J.,
Cohen N.,
Evans M.,
Hockey A.,
Speight J.,
WhatelySmith C.
Publication year - 2015
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12528
Subject(s) - insulin glargine , medicine , insulin , insulin aspart , type 2 diabetes , regimen , diabetes mellitus , endocrinology , basal (medicine) , glycemic , hypoglycemia
Aim To test the hypothesis that a ‘basal plus’ regimenadding once‐daily main‐meal fast‐acting insulin to basal insulin once dailywould be non‐inferior to biphasic insulin twice daily as assessed by glycated haemoglobin ( HbA1c ) concentration (predefined as ≤0.4%), but would provide superior treatment satisfaction. Methods This open‐label trial enrolled adults to an 8‐ or 12‐week run‐in period, during which oral therapies except metformin were stopped and insulin glargine dose was titrated. Those with fasting glucose <7 mmol/l but HbA1c >7% (53 mmol/mol) were randomized to insulin glargine/glulisine once daily (n = 170) or insulin aspart/aspart protamine 30/70 twice daily (n = 165) for 24 weeks, with dose titration to glucose targets using standardized algorithms. Results For HbA1c , the basal plus regimen was non‐inferior to biphasic insulin (least squares mean difference, 0.21%, upper 97.5% confidence limit 0.38%) meeting the predefined non‐inferiority margin of 0.4%. Treatment satisfaction ( D iabetes T reatment S atisfaction Q uestionnaire change version and I nsulin T reatment S atisfaction Q uestionnaire total scores) significantly favoured basal plus. No difference was observed between the basal plus and the biphasic insulin groups in responders ( HbA1c <7%, 20.6 vs 27.9%; p = 0.12), weight gain (2.06 vs 2.50 kg; p = 0.2), diabetes‐specific quality of life ( A udit of D iabetes‐ D ependent Q uality of L ife average weighted impact (AWI) score) and generic health status (five‐dimension E uropean Q uality of L ife questionnaire). Overall hypoglycaemia rates were similar between groups (15.3 vs 18.2 events/patient‐year; p = 0.22); nocturnal hypoglycaemia was higher with the basal plus regimen (5.7 vs 3.6 events/patient‐year; p = 0.02). Conclusion In long‐standing type 2 diabetes with suboptimal glycaemia despite oral therapies and basal insulin, the basal plus regimen was non‐inferior to biphasic insulin for biomedical outcomes, with a similar overall hypoglycaemia rate but more nocturnal events.