Patients with type 2 diabetes inadequately controlled on premixed inPatients with type 2 diabetes inadequately controlledon premixed insulin: effect of initiating insulin glargineplus oral antidiabetic agents on glycaemic control indaily practice
 
Aim

Premixed insulin regimens are commonly used for type 2 diabetes mellitus(T2DM) patients. However, there is limited information regarding next-step therapyoptions in cases where premixed insulin does not provide adequate glycaemic control.This 12-week observational study of everyday clinical practice evaluated theefficacy and safety of insulin glargine (glargine) plus oral antidiabetic drugs (OADs)in T2DM patients previously treated with premixed insulin.
 
Methods

Type 2 diabetesmellitus patients taking premixed insulin were identified from German clinicsand were eligible to switch to glargine plus OADs at the physicians’ and patients’discretion, as part of routine clinical practice. The study design and conduct was inaccordance with German regulations. Fasting blood glucose (FBG), 2-h postprandialblood glucose (PPBG) and glycosylated haemoglobin (HbA1c) were measured at thestart and after a 12-week observation period.
 
Results

 A total of 5045 patientswere followed-up and received glargine plus OADs. FBG [start to end-point:9.9 ± 2.7 to 6.9 ± 1.5 mmol/l (178 ± 48 to 124 ± 26 mg/dl); p ￡ 0.001], 2-hPPBG [10.8 ± 2.8 to 7.8 ± 1.5 mmol/l (195 ± 50 to 140 ± 27 mg/dl)] and HbA1c(8.3 ± 1.2 to 7.2 ± 0.8%; p ￡ 0.001) improved significantly from start to endpoint,respectively. A total of 48.9%, 38.4% and 73.9% of patients had FBG< 6.7 mmol/l (< 120 mg/dl), 2-h PPBG < 7.2 mmol/l (< 130 mg/dl) or HbA1c< 7.5%, respectively, after 12 weeks. Significant reductions in body weight were observed between the start and end of the observation period. A total of 71adverse events were reported by 38 patients. Hypoglycaemia was the most commonevent.
 
Conclusions

This observational study shows that, in T2DM patients inadequately controlled with premixed insulin, switching therapy to glargineplus OADs is associated with significant improvements in FBG and HbA1c, andis well tolerated in everyday clinical practice. Further intensification of insulintherapy, perhaps by adding one or more injections of prandial insulin, would helpprovide further improvements in glycaemic control in these patients.