The effectiveness of insulin initiation regimens in patients with type 2 diabetes mellitus: a large national medical records review study comparing a basal insulin analogue to premixed insulin.Curr Med Res Opin 2007; 23(12):3017-23CM
The objective of the study was to compare the level of HbA(1c) reduction between a once-daily basal insulin analogue (glargine, GLG) and two twice-daily premixed insulin analogue formulations (premixed insulin lispro 75/25, PIL; premixed human insulin 70/30, PHI) in patients with type 2 diabetes mellitus (T2DM) initiating insulin therapy.
RESEARCH DESIGN AND METHODS
Data were extracted from a US national medical records database for this retrospective, 18-month, observational, cohort study. Patients with T2DM were initiated on GLG (n = 3624), PIL (n = 895) or PHI (n = 3647). A combined premixed insulin group (CPI; n = 4542) was formed for data analyses. Propensity score methods were used to adjust for 19 baseline characteristics.
MAIN OUTCOME MEASURES
Adjusted and unadjusted reductions in HbA(1c) at six time points post-insulin initiation for a period of 18 months.
Reductions in mean HbA(1c) relative to baseline were demonstrated by all cohorts for all treatment periods. After adjusting for baseline differences, the CPI cohort consistently demonstrated greater reductions in HbA(1c) (0.04-0.14%; p < 0.05), compared to the GLG cohort. The PIL cohort consistently demonstrated the greatest reductions in HbA(1c) (0.26-0.65%; p < 0.05), compared to the GLG cohort.
Retrospective study design and vulnerabilities to patient drop-outs.
In clinical practice settings, greater reductions in HbA(1c) were found in patients with premixed insulin than with a basal insulin analogue with the greatest reduction observed with premixed insulin lispro 75/25, confirming the observations of randomized, controlled trials.