Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Patients with T2D Uncontrolled on NPH or Premixed Insulins as Part of Routine Clinical Practice in Bulgaria: ToUPGRADE Study

Abstract

Introduction The aim of this study is to demonstrate the real-life effectiveness and safety of insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes (T2D) previously uncontrolled on NPH ± prandial insulin or premixed insulins in routine clinical practice in Bulgaria. Methods This was a 24-week prospective, observational study performed in 40 inpatient and outpatient sites across the country. Results A total of 286 patients were included in the study. The mean age (± SD) was 61.2 ± 10.0 years with duration of diabetes of 11.64 ± 7.5 years and body mass index (BMI) of 32.1 ± 5.7 kg/m 2 . HbA1c before Gla-300 initiation was 9.8 ± 1.0%, and fasting plasma glucose (FPG) was 13.1 ± 3.4 mmol/L. HbA1c and FPG change from baseline to week 24 was − 1.86% ( p < 0.001) and − 4.8 mmol/L ( p < 0.001), respectively. The proportion of patients reaching their individualized HbA1c at week 24 was 39.1% (95% CI 33.3–45.1%), while the proportion of patients reaching their individualized HbA1c target without confirmed and/or severe hypoglycaemia was 34.8% (95% CI 29.2–40.7%). At study end, 19.0% (95% CI 14.6–24.1%) achieved HbA1c < 7%. Body weight decreased from 88.3 to 87.0 kg from baseline to week 24 with mean change of − 1.3 kg ( p < 0.001). The incidence and event rates of anytime confirmed (≤ 3.9 mmol/L) and/or severe hypoglycaemia were low: 7.7% and 0.42 events per patient-year, respectively. The overall Insulin Treatment Satisfaction Questionnaire (ITSQ) score increased from 53.2 to 78.2 from baseline to week 24 and the difference of 25.1 ± 21.5 points was significant ( p < 0.001). Conclusions In real-life settings, Gla-300 significantly improved glycaemic control and insulin treatment satisfaction in people with T2D who were inadequately controlled with NPH ± prandial insulin or premixed insulin analogues. Improvement of glycaemic control was associated with a very low risk of hypoglycaemia and with significant weight loss irrespective of the previous insulin regimen. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01022-0.

Switching from Neutral Protamine Hagedorn (NPH) Insulin to Insulin Glargine 300 U/mL in Older and Younger Patients with Type 2 Diabetes: A Post Hoc Analysis of a Multicenter, Prospective, Observational Study

“…By showing that Gla-300 improved glycemic control and reduced the frequency of hypoglycemia both in patients aged 65 years and in those aged [ 65 years, our study adds to the existing evidence supporting the use of Gla-300 in older patients with poorly controlled T2D, particularly because the reduction in the frequency of hypoglycemia in our study was greater among patients aged [ 65 years. The risk of hypoglycemia in patients with T2D uncontrolled on different insulin regimens decreased substantially after switching to Gla-300 in previous real-world studies [24,25]. In our study, the reduction in hypoglycemia risk was greater in patients aged[65 years primarily because these patients had substantially greater hypoglycemia frequency at baseline.…”

“…The risk of hypoglycemia in patients with T2D uncontrolled on different insulin regimens decreased substantially after switching to Gla-300 in previous real-world studies [ 24 , 25 ]. In our study, the reduction in hypoglycemia risk was greater in patients aged > 65 years primarily because these patients had substantially greater hypoglycemia frequency at baseline.…”

Glycaemic Control in People with Type 2 Diabetes Mellitus Switching from Basal Insulin to Insulin Glargine 300 U/ml (Gla-300): Results from the REALI Pooled Database

“…This REALI analysis included pooled data from 11 multicentre, prospective, open-label studies of a minimum duration of 24 weeks conducted between June 2015 and April 2019 in Germany, Austria, Switzerland, the Netherlands, Spain, France, the Czech Republic, Greece, Poland, Denmark, Slovenia, Slovakia, Croatia, the UK, Belgium, Serbia, Bulgaria, and Hungary [9][10][11][12][13][14][15][16][17][18][19]. The methodology of the REALI project and previous analyses from the REALI database have been presented elsewhere [20][21][22].…”

“…In the EDITION phase III clinical trial programme performed in a large population with a broad clinical spectrum of T2DM, patients who switched to Gla-300 from another BI, either Gla-100 or NPH insulin, demonstrated comparable glycaemic control with consistently fewer hypoglycaemic events at any time of the day and nocturnally compared with those who switched to Gla-100 [7]. Real-world evidence concerning switching to Gla-300 has also been encouraging, with real-life prospective studies from different countries across Europe showing that a direct switch to Gla-300 from other BIs resulted in improved glycaemic control and a reduced risk of hypoglycaemia without weight gain [8][9][10][11][12][13]. However, there are very limited prospective real-world data evaluating the switch from NPH insulin to Gla-300, with only one published study from Poland prospectively assessing the effectiveness of switching from NPH insulin to Gla-300 in a total of 469 people with T2DM [8].…”

Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis

“…This analysis included pooled data from 14 multicentre, prospective, open-label studies [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] of a minimum duration of 24 weeks conducted among European adult patients with inadequately controlled T2DM who initiated Gla-300 treatment (Table 1). The rationale, methodology and a detailed description of the variables have been already provided in the published protocol of the REALI project [30].…”