Endocrine Abstracts

This 24-week, multicentre, open, parallel group study compared the efficacy and safety of two different regimens for initiating insulin therapy. Insulin-naive patients with fasting blood glucose (FBG) levels >=6.7 mmol/L (>=120 mg/dL) and HbA_1c levels 7.5-10.5% on oral antidiabetic agents (OADs: glimepiride [Amaryl] or other sulfonylureas plus metformin) were randomized to insulin glargine (LANTUS) once daily in the morning with continued OADs (Glarg + OADs) or twice-daily premixed insulin (30% regular/70% NPH insulin [70/30]) as monotherapy. Insulin dosage was titrated to target FBG <=5.6mmol/L (<=100 mg/dL) with Glarg + OADs and to FBG <=5.6mmol/L and pre-dinner BG <=5.6mmol/L with 70/30, using weekly forced-titration algorithm. 364 patients with similar baseline characteristics (59% male; mean age 60.6 plus/minus 8.9 years; mean body mass index [BMI] 29.6 plus/minus 3.6 kg/m2; mean diabetes duration 9.9 plus/minus 6.8 years; mean HbA_1c 8.85 plus/minus 0.93%; mean FBG 9.5 plus/minus 2.0 mmol/L [172 plus/minus 36 mg/dL]) were included in the intent-to-treat analysis. 8-point blood glucose (BG) data showed better glycaemic control with Glarg + OADs versus 70/30 over 24 hours: mean difference in BG (mmol/L) from baseline to endpoint: FBG: -3.0 vs -2.0, p<0.0001; after breakfast: -2.8 vs -2.9; p=0.5809; lunch: -2.4 vs -2.2 (p=0.5582); after lunch: -2.2 vs -1.0; p<0.0001; dinner: -2.3 vs -1.1; p<0.0001; after dinner: -2.4 vs -1.4; p=0.0011; bedtime: -2.2 vs -1.7; p=0.0654; 3AM: -2.3 vs -1.6; p=0.0009. Patients on Glarg + OADs had fewer overall (3.0 vs 6.3/patient; p <0.0001), symptomatic (2.3 vs 4.4/patient; p=0.0009) and nocturnal (0.3 vs 0.8/patient; p=0.0067) hypoglycaemic events compared with patients treated with 70/30. By adding once-daily insulin glargine to existing sulfonylureas plus metformin, glycaemic control, as measured by 8-point BG profile, can be achieved more effectively, with better postprandial control and a reduced risk of hypoglycaemia, than stopping oral agents and starting twice-daily premixed insulin.