Eficacia y seguridad de una estrategia basal plus en pacientes con diabetes mellitus tipo 2 en la práctica clínica especializada. El estudio Basal Plus en España

Abstract

Objective

To evaluate the efficacy and safety of a Basal Plus strategy using insulin glargine (GLA) as basal insulin and insulin glulisine (GLU) as prandial insulin in patients with type 2 diabetes mellitus (T2DM) in everyday clinical practice.

Material and methods

Observational, retrospective study was performed between November 2010 and December 2011 (duration of observation: January-July 2010) in 65 endocrinology departments across Spain on consecutively enrolled T2DM patients previously treated with GLA, to whom one injection of GLU was added at the main meal. Primary analysis was to evaluate the change in HbA_1c from baseline (start of basal plus therapy, basal visit [BV]) to endpoint (at least after 3 months, basal plus visit [BPV]).

Results

A total of 363 patients were included (age 65 ± 10 years old, 54% male). After 6 months, the HbA_1c decreased from 8.5% to 7.4% (–1.1 ± .8%; 95% CI: 1.0-1.2; p < .001). More than a quarter (25.9%) of patients achieved an HbA_1c < 7.0% (.8% of patients at baseline). The percentage of patients with target fasting plasma glucose values (< 130 mg/dl) was 51.0% at baseline (BV), and 62.8% at the endpoint (BPV). Only 3 episodes of severe hypoglycemia were reported, of which none of them was nocturnal.

Conclusions

A Basal plus strategy with once daily insulin glargine plus insulin glulisine at the main meal is effective and safe in improving glycemic control in clinical practice in patients with T2DM previously not on treatment targets.