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 (LanScape)

Vora, J., Cohen, N., Evans, M., Hockey, A., Speight, J. and Whately-Smith, C. 2015, 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 (LanScape), Diabetes, obesity and metabolism, vol. 17, no. 12, pp. 1133-1141, doi: 10.1111/dom.12528.

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Title 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 (LanScape)
Author(s) Vora, J.
Cohen, N.
Evans, M.
Hockey, A.
Speight, J.ORCID iD for Speight, J. orcid.org/0000-0002-1204-6896
Whately-Smith, C.
Journal name Diabetes, obesity and metabolism
Volume number 17
Issue number 12
Start page 1133
End page 1141
Total pages 9
Publisher Wiley
Place of publication London, Eng.
Publication date 2015-12
ISSN 1463-1326
Keyword(s) clinical trial
insulin therapy
phase IV
type 2 diabetes
Science & Technology
Life Sciences & Biomedicine
Endocrinology & Metabolism
QUALITY-OF-LIFE
TREATMENT SATISFACTION QUESTIONNAIRE
TO-TARGET TRIAL
PREMIXED INSULIN
ORAL-THERAPY
MELLITUS
ANALOG
MANAGEMENT
METFORMIN
EUROQOL
Summary AIM: To test the hypothesis that a 'basal plus' regimenadding once-daily main-meal fast-acting insulin to basal insulin once dailywould 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 (Diabetes Treatment Satisfaction Questionnaire change version and Insulin Treatment Satisfaction Questionnaire 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 (Audit of Diabetes-Dependent Quality of Life average weighted impact (AWI) score) and generic health status (five-dimension European Quality of Life 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.
Language eng
DOI 10.1111/dom.12528
Field of Research 1103 Clinical Sciences
110306 Endocrinology
Socio Economic Objective 920401 Behaviour and Health
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, Wiley
Persistent URL http://hdl.handle.net/10536/DRO/DU:30080581

Document type: Journal Article
Collection: School of Psychology
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