Treating Subjects with Type Diabetes with Multiple Injections Basal Bolus Therapy

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Multiple injections with fast-acting insulin before the meals and intermediate or long-acting insulin at bedtime (basal-bolus regimen) is the first choice insulin regimen in most type 1 patients, but is not used very much in patients with type 2 diabetes. Nevertheless, prandial glucose regulation is an emerging concept, since epidemiological and mechanistic studies indicate that postprandial glucose contributes significantly to overall glycaemic exposure and also contributes to the vascular complications in type 2 diabetes [34,45]. Adding prandial insulin to basal insulin is a logical approach when the target of HbAlc cannot be achieved by the combination of basal insulin and oral therapy. Basal-bolus therapy represents the most physiological insulin regimen, but is more complex and the patient needs to be more educated and motivated for glucose monitoring. A few studies have evaluated the efficacy of multiple injections in type 2 diabetic patients.

In the first study the efficacy and safety of a basal-bolus regimen compared insulin detemir or NPH insulin in combination with mealtime insulin aspart in 505 patients with type 2 diabetes (BMI 30.4 ± 5.3 kg/m2, HbAlc 7.9 ± 1.3%) [46]. The patients were randomised 2:1 to insulin detemir or NPH insulin. After 26 weeks significant reduction in HbAlc was observed for both insulin detemir (0.2%) and NPH insulin (0.4%). HbAlc was comparable at study end (insulin detemir 7.6% and insulin NPH 7.5%). Nine points self-measured blood glucose profiles were similar for the two treatments as were reduction in fasting plasma glucose. The within-subject day-to-day variation in fasting plasma glucose was significantly lower with insulin detemir. Moreover, patients receiving insulin detemir gained significantly less body weight than those treated with NPH insulin (1.0 and 1.8 kg, respectively). The frequency of hypo-glycaemia was similar in the two groups. Dose of basal insulin and insulin aspart was not different between the groups.

In a second study detemir plus aspart was compared with NPH and human fast-acting insulin [47]. Nocturnal hypoglycaemia weight gain and within-person variation in self-monitored plasma glucose were less in the analogue regimen, indicating, as found in patients with type 1 diabetes, that the use of analogue insulin reduces weight gain, hypoglycaemia and day-to-day variation in plasma glucose within subjects.

Three studies, including 722, 295 and 148 patients, compared lispro with human fast-acting insulin in combination with basal insulin found no difference in HbAlc. In one of the studies (n = 722) fewer episodes of hypoglycaemia were registered. In all studies postprandial plasma glucose was lower with the rapid-acting analogue than with human insulin [48-50].

In a fourth study the rapid-acting insulin analogue glulisine from Sanofi aventis was compared with fast-acting human insulin. NPH insulin was used as basal insulin in both arms (n = 876). After 26 weeks of treatment, 0.16% greater reduction in HbAlc and lower postprandial glucose excursions in favour of insulin glulisine were observed, but without any differences in episodes of hypoglycaemia [51].

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