Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine

Clinical practice experience from a German subgroup of the PREDICTIVE study

Luigi Fernando Meneghini, K. H. Rosenberg, C. Koenen, M. J. Merilainen, H. J. Lüddeke

Research output: Contribution to journalArticle

85 Citations (Scopus)

Abstract

Aim: The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation (PREDICTIVE) Study is a large, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice. Methods: This subgroup analysis of the German cohortof PREDICTIVE evaluates over 3 months, patients with type 2 diabetes who were transferred to insulin detemir ± oral antidiabetic drugs (OADs) from an OAD-only regimen (n = 1321), NPH insulin ± OADs (n = 251) or insulin glargine ± OADs (n = 260). Results: Among all groups, 3 months after starting treatment with insulin detemir, total, daytime and nocturnal hypoglycaemic events/patient were reduced by 84, 80 and 90%, respectively, from baseline. No major hypoglycaemic events were reported during treatment with insulin detemir. HbAlc was significantly reduced from baseline in each of the subgroups (-1.29,-0.60 and-0.59% for patients previously taking OADs only, NPH insulin ± OADs and insulin glargine ± OADs respectively; p < 0.0001), as was fasting blood glucose (FBG) (-58.1, -29.1 and-24.6 mg/dl; p < 0.0001) and FBG variability-8.2 mg/dl, -5.7 mg/dl; p < 0.0001 and -5.1 mg/dl; p = 0.0008). All subgroups combined lost an average of 0.9 kg of body weight (p < 0.0001) during the study. Total daily basal insulin dose increased slightly from baseline for those patients on a prior insulin regimen, and in this study 79% of patients used insulin detemir once daily. Conclusions: These data confirm the short-term safety and efficacy of insulin detemir ± OADs in a real-world scenario and support the findings of randomized controlled clinical trials with insulin detemir, including its limited effects on body weight.

Original languageEnglish
Pages (from-to)418-427
Number of pages10
JournalDiabetes, Obesity and Metabolism
Volume9
Issue number3
DOIs
StatePublished - May 1 2007

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Isophane Insulin
Hypoglycemia
Hypoglycemic Agents
Type 2 Diabetes Mellitus
Weight Gain
Insulin
Blood Glucose
Fasting
Body Weight
Insulin Detemir
Insulin Glargine
Safety
Observational Studies
Randomized Controlled Trials

Keywords

  • Insulin detemir
  • Insulin glargine
  • NPH insulin
  • Observational study
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

@article{05ad29bef5134b79b46f2fc0d4cfd32a,
title = "Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: Clinical practice experience from a German subgroup of the PREDICTIVE study",
abstract = "Aim: The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation (PREDICTIVE) Study is a large, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice. Methods: This subgroup analysis of the German cohortof PREDICTIVE evaluates over 3 months, patients with type 2 diabetes who were transferred to insulin detemir ± oral antidiabetic drugs (OADs) from an OAD-only regimen (n = 1321), NPH insulin ± OADs (n = 251) or insulin glargine ± OADs (n = 260). Results: Among all groups, 3 months after starting treatment with insulin detemir, total, daytime and nocturnal hypoglycaemic events/patient were reduced by 84, 80 and 90{\%}, respectively, from baseline. No major hypoglycaemic events were reported during treatment with insulin detemir. HbAlc was significantly reduced from baseline in each of the subgroups (-1.29,-0.60 and-0.59{\%} for patients previously taking OADs only, NPH insulin ± OADs and insulin glargine ± OADs respectively; p < 0.0001), as was fasting blood glucose (FBG) (-58.1, -29.1 and-24.6 mg/dl; p < 0.0001) and FBG variability-8.2 mg/dl, -5.7 mg/dl; p < 0.0001 and -5.1 mg/dl; p = 0.0008). All subgroups combined lost an average of 0.9 kg of body weight (p < 0.0001) during the study. Total daily basal insulin dose increased slightly from baseline for those patients on a prior insulin regimen, and in this study 79{\%} of patients used insulin detemir once daily. Conclusions: These data confirm the short-term safety and efficacy of insulin detemir ± OADs in a real-world scenario and support the findings of randomized controlled clinical trials with insulin detemir, including its limited effects on body weight.",
keywords = "Insulin detemir, Insulin glargine, NPH insulin, Observational study, Type 2 diabetes",
author = "Meneghini, {Luigi Fernando} and Rosenberg, {K. H.} and C. Koenen and Merilainen, {M. J.} and L{\"u}ddeke, {H. J.}",
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TY - JOUR

T1 - Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine

T2 - Clinical practice experience from a German subgroup of the PREDICTIVE study

AU - Meneghini, Luigi Fernando

AU - Rosenberg, K. H.

AU - Koenen, C.

AU - Merilainen, M. J.

AU - Lüddeke, H. J.

PY - 2007/5/1

Y1 - 2007/5/1

N2 - Aim: The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation (PREDICTIVE) Study is a large, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice. Methods: This subgroup analysis of the German cohortof PREDICTIVE evaluates over 3 months, patients with type 2 diabetes who were transferred to insulin detemir ± oral antidiabetic drugs (OADs) from an OAD-only regimen (n = 1321), NPH insulin ± OADs (n = 251) or insulin glargine ± OADs (n = 260). Results: Among all groups, 3 months after starting treatment with insulin detemir, total, daytime and nocturnal hypoglycaemic events/patient were reduced by 84, 80 and 90%, respectively, from baseline. No major hypoglycaemic events were reported during treatment with insulin detemir. HbAlc was significantly reduced from baseline in each of the subgroups (-1.29,-0.60 and-0.59% for patients previously taking OADs only, NPH insulin ± OADs and insulin glargine ± OADs respectively; p < 0.0001), as was fasting blood glucose (FBG) (-58.1, -29.1 and-24.6 mg/dl; p < 0.0001) and FBG variability-8.2 mg/dl, -5.7 mg/dl; p < 0.0001 and -5.1 mg/dl; p = 0.0008). All subgroups combined lost an average of 0.9 kg of body weight (p < 0.0001) during the study. Total daily basal insulin dose increased slightly from baseline for those patients on a prior insulin regimen, and in this study 79% of patients used insulin detemir once daily. Conclusions: These data confirm the short-term safety and efficacy of insulin detemir ± OADs in a real-world scenario and support the findings of randomized controlled clinical trials with insulin detemir, including its limited effects on body weight.

AB - Aim: The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation (PREDICTIVE) Study is a large, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice. Methods: This subgroup analysis of the German cohortof PREDICTIVE evaluates over 3 months, patients with type 2 diabetes who were transferred to insulin detemir ± oral antidiabetic drugs (OADs) from an OAD-only regimen (n = 1321), NPH insulin ± OADs (n = 251) or insulin glargine ± OADs (n = 260). Results: Among all groups, 3 months after starting treatment with insulin detemir, total, daytime and nocturnal hypoglycaemic events/patient were reduced by 84, 80 and 90%, respectively, from baseline. No major hypoglycaemic events were reported during treatment with insulin detemir. HbAlc was significantly reduced from baseline in each of the subgroups (-1.29,-0.60 and-0.59% for patients previously taking OADs only, NPH insulin ± OADs and insulin glargine ± OADs respectively; p < 0.0001), as was fasting blood glucose (FBG) (-58.1, -29.1 and-24.6 mg/dl; p < 0.0001) and FBG variability-8.2 mg/dl, -5.7 mg/dl; p < 0.0001 and -5.1 mg/dl; p = 0.0008). All subgroups combined lost an average of 0.9 kg of body weight (p < 0.0001) during the study. Total daily basal insulin dose increased slightly from baseline for those patients on a prior insulin regimen, and in this study 79% of patients used insulin detemir once daily. Conclusions: These data confirm the short-term safety and efficacy of insulin detemir ± OADs in a real-world scenario and support the findings of randomized controlled clinical trials with insulin detemir, including its limited effects on body weight.

KW - Insulin detemir

KW - Insulin glargine

KW - NPH insulin

KW - Observational study

KW - Type 2 diabetes

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DO - 10.1111/j.1463-1326.2006.00674.x

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