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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 (LanScape).
Diabetes Obes Metab. 2015 Dec; 17(12):1133-41.DO

Abstract

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.

Authors+Show Affiliations

Royal Liverpool University Hospital, Liverpool, UK.Baker IDI Heart & Diabetes Institute, Melbourne, Australia.University Hospital, Llandough, UK.Sanofi, Guildford, UK.AHP Research, Hornchurch, UK. The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Australia. School of Psychology, Deakin University, Burwood, Australia.Whately-Smith Ltd, King's Langley, UK.

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26085028

Citation

Vora, J, et al. "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 & Metabolism, vol. 17, no. 12, 2015, pp. 1133-41.
Vora J, Cohen N, Evans M, et al. 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 Obes Metab. 2015;17(12):1133-41.
Vora, J., Cohen, N., Evans, M., Hockey, A., Speight, J., & 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 & Metabolism, 17(12), 1133-41. https://doi.org/10.1111/dom.12528
Vora J, et al. 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 Obes Metab. 2015;17(12):1133-41. PubMed PMID: 26085028.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Vora,J, AU - Cohen,N, AU - Evans,M, AU - Hockey,A, AU - Speight,J, AU - Whately-Smith,C, Y1 - 2015/09/04/ PY - 2015/01/28/received PY - 2015/06/01/revised PY - 2015/06/10/accepted PY - 2015/6/19/entrez PY - 2015/6/19/pubmed PY - 2016/8/16/medline KW - clinical trial KW - insulin therapy KW - phase IV KW - type 2 diabetes SP - 1133 EP - 41 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 17 IS - 12 N2 - 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. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/26085028/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__ L2 - https://doi.org/10.1111/dom.12528 DB - PRIME DP - Unbound Medicine ER -