Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study.

PURPOSE: To assess quality of life, glycemic control, and safety/tolerability associated with liraglutide versus insulin initiation in patients with type 2 diabetes in Germany. METHODS: Liraglutide/insulin-naïve adults with type 2 diabetes and inadequate glycemic control despite using oral antidiabetic medication were assigned to liraglutide (≤1.8 mg daily; n=878) or any insulin (n=382) according to the treating physician's decision and followed for 52 weeks. The primary objective was to evaluate Audit of Diabetes-Dependent Quality of Life (ADDQoL) scores. RESULTS: At baseline, the liraglutide group was younger and had shorter type 2 diabetes duration, lower glycated hemoglobin (HbA1c), higher body mass index, and a lower prevalence of certain diabetes-related complications than the insulin group (all p<0.05). ADDQoL average weighted impact scores improved numerically in both groups from baseline to 52 weeks (mean difference [95% confidence interval], liraglutide vs. insulin: 0.159 [-0.023;0.340]; not significant). Changes in general wellbeing and five ADDQoL domains significantly favored liraglutide (remaining 14 domains, not significant). HbA1c reductions were greater with insulin than liraglutide (-2.0% vs. -1.2%; p<0.01); however, mean HbA1c after 52 weeks was 7.2% in both groups. Compared with insulin, liraglutide significantly decreased body mass index (-1.54 kg/m2 vs. +0.27 kg/m2; p<0.001), systolic blood pressure (-5.03 mmHg vs. -1.03 mmHg; p<0.01) and non-severe hypoglycemia (0.85% vs. 4.55% at 52 weeks; p<0.01). Adverse drug reactions were reported for<3% of patients in both groups. CONCLUSIONS: Liraglutide improved certain ADDQoL components and reduced body mass index, systolic blood pressure, and non-severe hypoglycemia versus insulin. Both treatments improved glycemic control.

Treatment-dependent and treatment-independent risk factors associated with the risk of diabetes-related events: a retrospective analysis based on 229,042 patients with type 2 diabetes mellitus.

BACKGROUND: The aim of this study was to analyse which factors predict the real-world macro-/microvascular event, hospitalisation and death risk in patients with type 2 diabetes mellitus. Furthermore, we aimed to investigate whether there exists both an under- and over-treatment risk of these patients. METHODS: We used a German claims/clinical data set covering the years 2010-12. Diabetes-related events were defined as (1) macro-, (2) microvascular events leading to inpatient hospitalisation, (3) other hospitalisations with type 2 diabetes mellitus as main diagnosis, (4) all-cause death and (5) a composite outcome including all event categories 1-4. Factors associated with event risk were analysed by a Kaplan-Meier curve analysis and by multivariable Cox regression models. RESULTS: 229,042 patients with type 2 diabetes mellitus (mean age 70.2 years; mean CCI 6.03) were included. Among factors that increased the event risk were patients' age, male gender, the adapted Charlson Comorbidity Index, the adapted Diabetes Complication Severity Index, previous events, and number of prescribed chronic medications. For systolic blood pressure/HbA1C, a double-J/U-curve pattern was detected: HbA1C of 6-6.5% (42-48 mmol/mol) and systolic blood pressure of 130-140 mmHg (17.3-18.7kPa) were associated with the lowest event risk, values below/above that range were associated with higher risk. However, this pattern was mainly driven by the death risk and was much less clearly observed for the macrovascular/microvascular/hospitalization risk and for young/less comorbid patients. CONCLUSIONS: Both blood pressure and HbA1C seem to be very important treatment targets, especially in comorbid old patients. It is of particular clinical importance that both over- and under-treatment pose a threat to patients with type 2 diabetes mellitus.

Real life treatment of diabetes mellitus type 2 patients: an analysis based on a large sample of 394,828 German patients.

OBJECTIVES: The aim of this claims-based data analysis was to describe the care of German T2DM patients and to determine which subgroups could be differentiated in terms of the achieved T2DM-related treatment results, the underlying comorbidities, and the achieved comorbidity-related treatment results. METHODS: We included all T2DM patients insured by a large sickness fund in 2010/2011. We defined 12 subgroups according to observed HbA1C, blood pressure and Charlson Comorbidity Index (CCI). For each subgroup, available sociodemographic and clinical information were reported. Different treatment variables were described. T2DM-related events leading to acute hospitalisations were reported. RESULTS: We included 394,828 T2DM patients in our analysis; for 228,703 patients' detailed data as basis for subgroup classification were available. For 4.5% of these patients, a HbA1C >9% was observed. 21,833 of the T2DM patients were affected by a T2DM-related event; the risk was 5.53% per patient year; 1.74% of the patients suffered from more than one event. Most frequent event types were hospitalisation with T2DM as primary diagnosis (2.39%), vascular interventions/stent implantations (1.92%), and ischaemic stroke (1.19%). There were significant differences between the observed subgroups in terms of T2DM-related event risk. CONCLUSION: Overall, our data indicate that the typically treated T2DM patient has a number of comorbidities and thus treatment focused solely on T2DM is neither possible nor clinically meaningful. Particularly those patients who reached HbA1C goals, but had also achieved relevant additional treatment goals reached low yearly T2DM event rates whereas subgroups failing to achieve one or several treatment goals are facing much higher event risks.