Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes

Subgroup analysis from the PREDICTIVE™ study

A. Dornhorst, H. J. Lüddeke, S. Sreenan, P. Kozlovski, J. B. Hansen, B. J. Looij, L. Meneghini

Research output: Contribution to journalArticle

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Abstract

Objective: Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation (PREDICTIVE™) 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 HbA 1c 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.

Original languageEnglish (US)
Pages (from-to)659-665
Number of pages7
JournalInternational Journal of Clinical Practice
Volume62
Issue number4
DOIs
StatePublished - Apr 2008

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Type 2 Diabetes Mellitus
Weight Gain
Hypoglycemic Agents
Insulin
Body Mass Index
Weights and Measures
Fasting
Hemoglobins
Glucose
Insulin Detemir
Drug-Related Side Effects and Adverse Reactions
Hypoglycemia
Observational Studies
Weight Loss
Therapeutics
Body Weight
Regression Analysis
Clinical Trials
Prospective Studies
Physicians

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes : Subgroup analysis from the PREDICTIVE™ study. / Dornhorst, A.; Lüddeke, H. J.; Sreenan, S.; Kozlovski, P.; Hansen, J. B.; Looij, B. J.; Meneghini, L.

In: International Journal of Clinical Practice, Vol. 62, No. 4, 04.2008, p. 659-665.

Research output: Contribution to journalArticle

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abstract = "Objective: Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation (PREDICTIVE™) 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-na{\"i}ve 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-na{\"i}ve 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 HbA 1c 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 na{\"i}ve 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.",
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T2 - Subgroup analysis from the PREDICTIVE™ study

AU - Dornhorst, A.

AU - Lüddeke, H. J.

AU - Sreenan, S.

AU - Kozlovski, P.

AU - Hansen, J. B.

AU - Looij, B. J.

AU - Meneghini, L.

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N2 - Objective: Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation (PREDICTIVE™) 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 HbA 1c 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.

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