PREDICTIVE Study Group: Dr Stefan Aczel; Dr Jean Louis Chiasson; Dr Anne Dornhorst; Prof. Baptist Gallwitz; Dr Francisco Hernandez; Dr Marek Honka; Dr Andrew Johnson; Dr Allen King; Dr Lena Landstedt-Hallin; Dr Bert-Jan Looij; Dr Hans-Joachim Lüddeke; Prof. Michel Marre; Dr Stephan Maxeiner; Dr Carmen Fajardo Montañana; Dr Areti Philotheou; Dr Adam Robinson; Dr Seamus Sreenan; Dr Marcos Antonio Tambascia; Dr Bruce Trippe; Dr Anat Tsur; Dr Antti Virkamäki and Prof. Mustafa Yenigun.
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Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVETM study
Article first published online: 6 MAR 2008
DOI: 10.1111/j.1742-1241.2008.01715.x
© 2008 The Authors
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How to Cite
Dornhorst, A., Lüddeke, H.-J., Sreenan, S., Kozlovski, P., Hansen, J. B., Looij, B.-J., Meneghini, L. and on behalf of the PREDICTIVE Study Group (2008), Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVETM study. International Journal of Clinical Practice, 62: 659–665. doi: 10.1111/j.1742-1241.2008.01715.x
Publication History
- Issue published online: 6 MAR 2008
- Article first published online: 6 MAR 2008
- Paper received October 2007, accepted January 2008
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Summary
Objective: Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation (PREDICTIVETM) is a multi-national, open-label, prospective, observational study assessing the safety and efficacy of insulin detemir in clinical practice. This post hoc subanalysis evaluates insulin-naïve patients on oral antidiabetic drugs (OADs) who were initiated on insulin detemir as basal therapy (± OADs).
Methods: The European cohort of the PREDICTIVE study currently includes 20,531 patients (12,981 with type 2 diabetes) who were prescribed insulin detemir and followed up for 12, 26 or 52 weeks. Here, we report data from a subgroup of 2377 OAD-treated, insulin-naïve type 2 diabetes patients for a mean follow-up of 14.4 weeks. Patients were prescribed insulin detemir as basal therapy (± OADs) by their physician, as part of routine clinical care. Results were reported in comparison with baseline observations.
Results: One serious adverse drug reaction was reported, which was a major hypoglycaemic episode. Treatment with insulin detemir (± OADs) significantly reduced mean haemoglobin A1c (HbA1c) (−1.3%; p < 0.0001), fasting glucose (−3.7 mmol/l; p < 0.0001), and within-patient fasting glucose variability (−0.5 mmol/l; p < 0.0001). In the majority of patients (82%), these improvements in glycaemic control were achieved with once daily administration of insulin detemir. There was a small reduction in mean body weight (−0.7 kg; p < 0.0001), which was most apparent in patients with a higher body mass index (BMI) at baseline. A significant negative relationship between weight change and baseline BMI was observed (greater the BMI, greater the weight reduction). Multiple regression analysis showed that BMI and HbA1c at baseline, and change in HbA1c, were all predictors for weight change (p < 0.0001 for all), with BMI being the strongest predictor.
Conclusions: Patients with type 2 diabetes naïve to insulin can be effectively treated with once-daily insulin detemir (± OADs) to achieve improved glycaemic control with no adverse effect on weight and a low risk of hypoglycaemia. These short-term results are consistent with the findings of clinical trials.