IngentaConnect Safety and efficacy of insulin detemir basal-bolus therapy in typ...

Authors: Dornhorst, Anne¹; Lüddeke, Hans-Joachim²; Honka, Marek³; Ackermann, Ralf W.⁴; Meriläinen, Markus⁴; Gallwitz, Baptist⁵; Sreenan, Seamus⁶; Predictive Study Group,

Source: Current Medical Research and Opinion, Volume 24, Number 2, February 2008 , pp. 369-376(8)

Publisher: LibraPharm

Abstract:

Objective: PREDICTIVE is a multi-national, prospective, observational study, assessing the safety and efficacy of insulin detemir in patients with diabetes.

Research design and methods: The European cohort includes 20 531 patients with diabetes (7420 type 1) from 11 countries. A subgroup of 4782 type 1 patients were transferred from a basal-bolus regimen with NPH insulin (n = 3117) or insulin glargine (n = 1665) to insulin detemir basal-bolus therapy; or from a human insulin basal-bolus regimen (n = 570) to insulin detemir/insulin aspart (part of the pre-study NPH group). Mean follow-up was 14.4 weeks. The primary endpoint was serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary endpoints were: incidence of overall and nocturnal hypoglycaemia; haemoglobin A_1c (HbA_1c); fasting glucose; within-patient fasting glucose variability; and change in body weight.

Results: SADRs were reported by 62 (2.0%) patients previously receiving NPH insulin, 45 (2.7%) patients previously receiving insulin glargine and seven (1.2%) patients previously receiving human basal-bolus insulins. Major hypoglycaemia was significantly reduced in NPH insulin (55%), insulin glargine (51%), and human basal-bolus insulin groups (54%; p < 0.0001 for all). Total and nocturnal hypoglycaemic episodes were also significantly reduced in all groups (p < 0.0001 for all). HbA_1c was reduced in patients previously receiving NPH insulin (0.5%), insulin glargine (0.4%), and human basal-bolus insulins (0.6%; p < 0.0001 for all). Mean fasting glucose and within-patient fasting glucose variability significantly decreased in all patients (p < 0.0001 for all). Body weight remained stable.

Conclusions: In this open-label, prospective, observational study, insulin detemir basal-bolus therapy improved glycaemic control and reduced hypoglycaemia with weight neutrality in type 1 patients in actual clinical practice.

Keywords: GLYCAEMIC CONTROL; HYPOGLYCAEMIA; INSULIN DETEMIR; OBSERVATIONAL; TYPE 1 DIABETES; WEIGHT NEUTRALITY

Document Type: Research article

DOI: 10.1185/030079908X260835

Affiliations: 1: Dept of Metabolic Medicine, Imperial College, London, United Kingdom 2: Praxis Lüddeke/Trauner, Munich, Germany 3: Fakultni nemocnice s poliklinikou Ostrava, Czech Republic 4: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark 5: Medizinische Klinik IV, Universitätsklinikum Tübingen, Tübingen, Germany 6: Dept of Endocrinology, Connolly Hospital, Dublin, Ireland

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Safety and efficacy of insulin detemir basal-bolus therapy in type 1 diabetes patients: 14-week data from the European cohort of the PREDICTIVE study