The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries

Kamlesh Khunti, S. Caputo, T. Damci, G. J. Dzida, Q. Ji, M. Kaiser, E. Karnieli, A. Liebl, R. J. Ligthelm, A. Nazeri, D. Orozco-Beltran, C. Pan, S. A. Ross, A. L. Svendsen, J. Vora, J. F. Yale, L. F. Meneghini, A. Maran, L. Raimundo, S. ArtolaS. Imamoglu

Research output: Contribution to journalArticle

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Abstract

Aims: Evaluate the safety and efficacy of once-daily insulin detemir initiated in routine clinical practice in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycaemic agents (OHAs). Methods: This large observational study was conducted in 10 countries. Adverse event data (including hypoglycaemia) and glycaemic control wererecorded before and 24 weeks following insulin initiation while patients continued routine clinical management. Results:In this study, 17 374 patients (53% male) were included. Mean pre-insulin values (±s.d.) were: age 62±12 years; body mass index (BMI) 29.3±5.4 kg/m2; diabetes duration 10±7 years; haemoglobin A1c (HbA1c) 8.9±1.6%. During the study, 27 patients experienced serious adverse drug reaction, severe hypoglycaemic events or both; and there were 31 episodes of severehypoglycaemia in 21 patients. After 24 weeks, HbA1c was 7.5±1.2% (change of -1.3%; p<0.001) and mean weight change was -0.6 kg (confidence interval -0.7, -0.5 kg, p<0.001). Daily insulin dose increased from 13±6 U (0.16±0.09 U/kg) to 22±16 U (0.27±0.17U/kg) by 24 weeks. Multivariate regression analysis identified several independent demographic and treatmentpredictors of end of study HbA1c. Conclusions: Addition of once-daily insulin detemir to patients with type 2 diabetes mellitus on OHA therapy resulted in few adverse events, significant improvements in glycaemic control, small reductions in weight and low rates of hypoglycaemia. On the basis of this study, concerns about hypoglycaemia or weight gain should not preclude initiation of basal insulin analogues in patients with poor glycaemic control on OHAs.

Original languageEnglish
Pages (from-to)1129-1136
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume14
Issue number12
DOIs
StatePublished - Dec 1 2012

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Hypoglycemic Agents
Type 2 Diabetes Mellitus
Safety
Hypoglycemia
Insulin
Hemoglobins
Insulin Detemir
Drug-Related Side Effects and Adverse Reactions
Weight Gain
Observational Studies
Weight Loss
Body Mass Index
Multivariate Analysis
Regression Analysis
Demography
Confidence Intervals
Weights and Measures

Keywords

  • Basal insulin
  • HbA1c
  • Hypoglycaemia
  • Metformin
  • Oral hypoglycaemic agent
  • Sulphonylurea
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries. / Khunti, Kamlesh; Caputo, S.; Damci, T.; Dzida, G. J.; Ji, Q.; Kaiser, M.; Karnieli, E.; Liebl, A.; Ligthelm, R. J.; Nazeri, A.; Orozco-Beltran, D.; Pan, C.; Ross, S. A.; Svendsen, A. L.; Vora, J.; Yale, J. F.; Meneghini, L. F.; Maran, A.; Raimundo, L.; Artola, S.; Imamoglu, S.

In: Diabetes, Obesity and Metabolism, Vol. 14, No. 12, 01.12.2012, p. 1129-1136.

Research output: Contribution to journalArticle

Khunti, K, Caputo, S, Damci, T, Dzida, GJ, Ji, Q, Kaiser, M, Karnieli, E, Liebl, A, Ligthelm, RJ, Nazeri, A, Orozco-Beltran, D, Pan, C, Ross, SA, Svendsen, AL, Vora, J, Yale, JF, Meneghini, LF, Maran, A, Raimundo, L, Artola, S & Imamoglu, S 2012, 'The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries', Diabetes, Obesity and Metabolism, vol. 14, no. 12, pp. 1129-1136. https://doi.org/10.1111/j.1463-1326.2012.01665.x
Khunti, Kamlesh ; Caputo, S. ; Damci, T. ; Dzida, G. J. ; Ji, Q. ; Kaiser, M. ; Karnieli, E. ; Liebl, A. ; Ligthelm, R. J. ; Nazeri, A. ; Orozco-Beltran, D. ; Pan, C. ; Ross, S. A. ; Svendsen, A. L. ; Vora, J. ; Yale, J. F. ; Meneghini, L. F. ; Maran, A. ; Raimundo, L. ; Artola, S. ; Imamoglu, S. / The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries. In: Diabetes, Obesity and Metabolism. 2012 ; Vol. 14, No. 12. pp. 1129-1136.
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AU - Khunti, Kamlesh

AU - Caputo, S.

AU - Damci, T.

AU - Dzida, G. J.

AU - Ji, Q.

AU - Kaiser, M.

AU - Karnieli, E.

AU - Liebl, A.

AU - Ligthelm, R. J.

AU - Nazeri, A.

AU - Orozco-Beltran, D.

AU - Pan, C.

AU - Ross, S. A.

AU - Svendsen, A. L.

AU - Vora, J.

AU - Yale, J. F.

AU - Meneghini, L. F.

AU - Maran, A.

AU - Raimundo, L.

AU - Artola, S.

AU - Imamoglu, S.

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N2 - Aims: Evaluate the safety and efficacy of once-daily insulin detemir initiated in routine clinical practice in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycaemic agents (OHAs). Methods: This large observational study was conducted in 10 countries. Adverse event data (including hypoglycaemia) and glycaemic control wererecorded before and 24 weeks following insulin initiation while patients continued routine clinical management. Results:In this study, 17 374 patients (53% male) were included. Mean pre-insulin values (±s.d.) were: age 62±12 years; body mass index (BMI) 29.3±5.4 kg/m2; diabetes duration 10±7 years; haemoglobin A1c (HbA1c) 8.9±1.6%. During the study, 27 patients experienced serious adverse drug reaction, severe hypoglycaemic events or both; and there were 31 episodes of severehypoglycaemia in 21 patients. After 24 weeks, HbA1c was 7.5±1.2% (change of -1.3%; p<0.001) and mean weight change was -0.6 kg (confidence interval -0.7, -0.5 kg, p<0.001). Daily insulin dose increased from 13±6 U (0.16±0.09 U/kg) to 22±16 U (0.27±0.17U/kg) by 24 weeks. Multivariate regression analysis identified several independent demographic and treatmentpredictors of end of study HbA1c. Conclusions: Addition of once-daily insulin detemir to patients with type 2 diabetes mellitus on OHA therapy resulted in few adverse events, significant improvements in glycaemic control, small reductions in weight and low rates of hypoglycaemia. On the basis of this study, concerns about hypoglycaemia or weight gain should not preclude initiation of basal insulin analogues in patients with poor glycaemic control on OHAs.

AB - Aims: Evaluate the safety and efficacy of once-daily insulin detemir initiated in routine clinical practice in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycaemic agents (OHAs). Methods: This large observational study was conducted in 10 countries. Adverse event data (including hypoglycaemia) and glycaemic control wererecorded before and 24 weeks following insulin initiation while patients continued routine clinical management. Results:In this study, 17 374 patients (53% male) were included. Mean pre-insulin values (±s.d.) were: age 62±12 years; body mass index (BMI) 29.3±5.4 kg/m2; diabetes duration 10±7 years; haemoglobin A1c (HbA1c) 8.9±1.6%. During the study, 27 patients experienced serious adverse drug reaction, severe hypoglycaemic events or both; and there were 31 episodes of severehypoglycaemia in 21 patients. After 24 weeks, HbA1c was 7.5±1.2% (change of -1.3%; p<0.001) and mean weight change was -0.6 kg (confidence interval -0.7, -0.5 kg, p<0.001). Daily insulin dose increased from 13±6 U (0.16±0.09 U/kg) to 22±16 U (0.27±0.17U/kg) by 24 weeks. Multivariate regression analysis identified several independent demographic and treatmentpredictors of end of study HbA1c. Conclusions: Addition of once-daily insulin detemir to patients with type 2 diabetes mellitus on OHA therapy resulted in few adverse events, significant improvements in glycaemic control, small reductions in weight and low rates of hypoglycaemia. On the basis of this study, concerns about hypoglycaemia or weight gain should not preclude initiation of basal insulin analogues in patients with poor glycaemic control on OHAs.

KW - Basal insulin

KW - HbA1c

KW - Hypoglycaemia

KW - Metformin

KW - Oral hypoglycaemic agent

KW - Sulphonylurea

KW - Type 2 diabetes mellitus

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