Titration and optimization trial for the initiation of insulin glargine 100 U/mL in patients with inadequately controlled type 2 diabetes on oral antidiabetic drugs (original) (raw)
2018, Diabetes, Obesity and Metabolism
For patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control, addition of basal insulin is recommended, but titration and optimization of basal insulin therapy in primary care is not well understood. We conducted an observational trial in 2470 patients with T2DM who initiated insulin glargine 100 U/L (Gla-100) on top of oral antidiabetic drugs. Physicians were free to choose either a "Davies," "Fritsche" or "individual" titration algorithm. We found that fasting blood glucose (FBG) and glycated haemoglobin (HbA1c) levels were effectively reduced by Gla-100; 65.9% of patients achieved the primary endpoint (FBG ≤6.1 mmol/L (110 mg/dL) or an individual HbA1c target). There were no significant differences in efficacy and safety between the algorithms used. The mean FBG decreased by 3.2 mmol/L (59 mg/dL) over 12 months, while the mean HbA1c decreased by 15.3 mmol/mol (1.4%)%. From a starting dose of 11.7 U/d, the Gla-100 dosage was 22.8 U/d at 12 months, with similar values in each group. Rates of hypoglycaemia were low and did not differ by titration algorithm. We conclude that Gla-100 was effective at reducing FBG and HbA1c, independent of the titration algorithm, but observed that algorithms were inconsistently applied in clinical practice. K E Y W O R D S basal, basal insulin-supported oral therapy, hypoglycaemia, insulin glargine, titration algorithm 1 | INTRODUCTION In type 2 diabetes mellitus (T2DM), oral antidiabetic drugs (OADs) provide effective blood glucose-lowering in the early stages of the condition, but treatment intensification with insulin is frequently required over time. 1 An initial dose of 10 U/d or 0.1 to 0.2 U/kg/d basal insulin is advocated in guidelines. 2 Titration is guided by fasting blood glucose (FBG) measurements until a stable level of 5.0 to 7.2 mmol/L ([70]90-130 mg/dL) is achieved. At present, no specific starting dose or titration algorithm for insulin initiation in patients with T2DM is advocated in German guidelines. 3 The joint position statement of the American Diabetes Association and the European Association for the Study of Diabetes provides recommendations for the starting dose, but the proposed titration approach lacks detail. 2,4 An observational trial was therefore established to analyse which algorithms were most commonly used for titrating insulin glargine in patients with T2DM and inadequate glycaemic