AIM: To compare over 3 years the efficacy of two treatment regimens combining continuous subcutaneous insulin infusion (CSII) and oral hypoglycaemic agents (OHA) in type 2 diabetic patients with HbA(1c) levels>8% despite OHA+/-insulin. METHODS:Fifty-nine patients were randomized to two groups. In both groups metformin was continued; CSII (velosulin) was used with minimal manipulation. Group A: the optimization of insulin doses was exerted on boluses to achieve postprandial glycaemia<9.99 mmol/l. Sulfonylurea, administered as a single dose at bedtime, was adjusted to attain fasting glycaemia<6.66 mmol/l. Group B: the optimization of insulin doses was exerted on night time basal rate to attain fasting glycaemia<6.66 mmol/l. Sulfonylurea, given before each meal, was adjusted to obtain postprandial glycaemia<9.99 mmol/l. RESULTS: During the 3 years follow-up, overall mean HbA(1c) values decreased similarly for both groups from baseline (9.45+/-0.83%) to 1, 2, 3 years (7.76+/-0.85%; 8.06+/-1.10%; 8.27+/-1.06% P<0.0001). The mean frequency of minor hypoglycaemia was 1.3+/-2.3 events per month per patient and 14 severe hypoglycaemic events occurred with no difference between the two groups. In both groups we observed a significant and similar weight gain and improvement in quality of life. CONCLUSION: Long-term combination therapy with OHA and CSII with only basic manipulation and optimization of insulin doses exerted on basal rate or on boluses is feasible, effective and well accepted in type 2 diabetes.
RCT Entities:
AIM: To compare over 3 years the efficacy of two treatment regimens combining continuous subcutaneous insulin infusion (CSII) and oral hypoglycaemic agents (OHA) in type 2 diabeticpatients with HbA(1c) levels>8% despite OHA+/-insulin. METHODS: Fifty-nine patients were randomized to two groups. In both groups metformin was continued; CSII (velosulin) was used with minimal manipulation. Group A: the optimization of insulin doses was exerted on boluses to achieve postprandial glycaemia<9.99 mmol/l. Sulfonylurea, administered as a single dose at bedtime, was adjusted to attain fasting glycaemia<6.66 mmol/l. Group B: the optimization of insulin doses was exerted on night time basal rate to attain fasting glycaemia<6.66 mmol/l. Sulfonylurea, given before each meal, was adjusted to obtain postprandial glycaemia<9.99 mmol/l. RESULTS: During the 3 years follow-up, overall mean HbA(1c) values decreased similarly for both groups from baseline (9.45+/-0.83%) to 1, 2, 3 years (7.76+/-0.85%; 8.06+/-1.10%; 8.27+/-1.06% P<0.0001). The mean frequency of minor hypoglycaemia was 1.3+/-2.3 events per month per patient and 14 severe hypoglycaemic events occurred with no difference between the two groups. In both groups we observed a significant and similar weight gain and improvement in quality of life. CONCLUSION: Long-term combination therapy with OHA and CSII with only basic manipulation and optimization of insulin doses exerted on basal rate or on boluses is feasible, effective and well accepted in type 2 diabetes.