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
- 30 August 2012
- journal article
- research article
- Published by Wiley in Diabetes, Obesity and Metabolism
- Vol. 14 (12), 1129-1136
- https://doi.org/10.1111/j.1463-1326.2012.01665.x
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 OHAsFunding Information
- Novo Nordisk
This publication has 32 references indexed in Scilit:
- Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trialDiabetes, Obesity and Metabolism, 2011
- Treatment regimens with insulin analogues and haemoglobin A1c target of <7% in type 2 diabetes: A systematic reviewDiabetes Research and Clinical Practice, 2010
- Insulin detemir: A historical perspective on a modern basal insulin analoguePrimary Care Diabetes, 2010
- Clinical characteristics of patients with type 2 diabetes mellitus at the time of insulin initiation: INSTIGATE observational study in SpainActa Diabetologica, 2009
- Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of TherapyDiabetes Care, 2009
- Long-acting insulin analogues versus NPH human insulin in type 2 diabetes: A meta-analysisDiabetes Research and Clinical Practice, 2008
- Addition of Biphasic, Prandial, or Basal Insulin to Oral Therapy in Type 2 DiabetesThe New England Journal of Medicine, 2007
- Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly Controlled Type 2 DiabetesClinical Therapeutics, 2006
- Improvement of Glycemic Control in Subjects With Poorly Controlled Type 2 DiabetesDiabetes Care, 2005
- Glimepiride Combined with Morning Insulin Glargine, Bedtime Neutral Protamine Hagedorn Insulin, or Bedtime Insulin Glargine in Patients with Type 2 DiabetesAnnals of Internal Medicine, 2003