Switching From Pre-mixed Insulin to Regimens with Insulin Glargine in Type 2 Diabetes: A Prospective, Observational Study of Data From Adriatic Countries

Petrovski, Goran; Gjergji, Dashamir; Grbić, Aleksandra; Vukovic, Blazenko; Krajnc, Mitja; Grulovic, Natasa

doi:10.1007/s13300-018-0467-4

Cited by 5 publications

(7 citation statements)

References 20 publications

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“…The reported mean body weight decrease in the Hungarian observational study in patients with T2D switched from human to Gla-300 based basal-bolus insulin regimen (− 0.94 kg) was similar to the mean body weight decrease in our study (− 1.3 kg) [ 12 ]. Switching from premixed insulins to insulin glargine-based regimen in patients with T2D has been also associated with a significant reduction in body weight (− 1.2 kg) in the real-life practice [ 16 ]. As OAD treatment continued in 97% of patients after switching to Gla-300.…”

Section: Discussionmentioning

confidence: 99%

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

Kamenov

Pehlivanova²,

Kuneva³

et al. 2021

Diabetes Ther

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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.

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Section: Discussionmentioning

confidence: 99%

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

Kamenov

Pehlivanova²,

Kuneva³

et al. 2021

Diabetes Ther

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“…Twenty studies reported insulin initiation and compared the outcomes between Gla-100 and premixed insulins [ 7 , 10 – 13 , 27 – 41 ]. In a majority of studies ( n = 19), the insulins were co-administered with OADs [ 7 , 10 – 13 , 27 – 37 , 39 – 41 ] (Table 3 ).…”

Section: Resultsmentioning

confidence: 99%

“…Gla-100 vs. Premixed Insulins Twenty studies reported insulin initiation and compared the outcomes between Gla-100 and premixed insulins [7,[10][11][12][13][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]. In a majority of studies (n = 19), the insulins were co-administered with OADs [7, 10-13, 27-37, 39-41] (Table 3).…”

Section: Safety Outcomes Primary Outcomes Hypoglycemic Eventsmentioning

confidence: 99%

“…Gla-100 vs. Premixed Insulin Other Glycemic Outcomes BG Profile In total, 19 studies reported either FPG or PPG levels at baseline, endpoint, and the mean change values. Gla-100 was found to provide better glucose control for FPG and reported statistically significant reduction in FPG levels in six studies of fair-to-good quality when compared to other premixed insulin regimens (P \ 0.0001 to \ 0.01) [12,27,28,33,39,41]. Significant improvements in the PPG levels were also observed in patients receiving Gla-100 compared to those receiving premixed insulin regimens (P \ 0.0001 and \ 0.01) in two studies of fair quality [12,28].…”

Section: Glycemic Variabilitymentioning

confidence: 99%

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Twenty Years of Insulin Gla-100: A Systematic Evaluation of Its Efficacy and Safety in Type 2 Diabetes Mellitus

Sethi

Unnikrishnan²,

Ayyar

et al. 2022

Diabetes Ther

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Introduction: This systematic review aims to present the current evidence base with respect to the initiation and intensification of insulin therapy with glargine 100 U/mL (Gla-100) compared to other insulins in people with type 2 diabetes mellitus (T2DM).Methods: A systematic literature search of PubMed (MEDLINE), EMBASE, and the Cochrane Central Register of controlled clinical trials databases was performed to identify studies published up to September 30, 2020 that compared the effects of Gla-100 to that of other insulin regimens in people with T2DM. Relevant information pertaining to the predefined outcomes of interest was extracted. Glycated hemoglobin (HbA1c) change and response rates along with overall hypoglycemia incidence were the primary efficacy and safety outcomes of interest.

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“…Previous studies have shown the impact of insulin treatments on the incidence of hypoglycemia, including comparing premixed insulin analogues to basal insulin analogues (with or without prandial insulin). In some cases, hypoglycemia rates were found to be slightly higher in patients population treated with premixed insulin analogues ( Petrovski et al, 2018 ).…”

Section: Experiments and Resultsmentioning

confidence: 99%

Q-Finder: An Algorithm for Credible Subgroup Discovery in Clinical Data Analysis — An Application to the International Diabetes Management Practice Study

Esnault¹,

Gadonna²,

Queyrel

et al. 2020

Front. Artif. Intell.

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Addressing the heterogeneity of both the outcome of a disease and the treatment response to an intervention is a mandatory pathway for regulatory approval of medicines. In randomized clinical trials (RCTs), confirmatory subgroup analyses focus on the assessment of drugs in predefined subgroups, while exploratory ones allow a posteriori the identification of subsets of patients who respond differently. Within the latter area, subgroup discovery (SD) data mining approach is widely used—particularly in precision medicine—to evaluate treatment effect across different groups of patients from various data sources (be it from clinical trials or real-world data). However, both the limited consideration by standard SD algorithms of recommended criteria to define credible subgroups and the lack of statistical power of the findings after correcting for multiple testing hinder the generation of hypothesis and their acceptance by healthcare authorities and practitioners. In this paper, we present the Q-Finder algorithm that aims to generate statistically credible subgroups to answer clinical questions, such as finding drivers of natural disease progression or treatment response. It combines an exhaustive search with a cascade of filters based on metrics assessing key credibility criteria, including relative risk reduction assessment, adjustment on confounding factors, individual feature’s contribution to the subgroup’s effect, interaction tests for assessing between-subgroup treatment effect interactions and tests adjustment (multiple testing). This allows Q-Finder to directly target and assess subgroups on recommended credibility criteria. The top-k credible subgroups are then selected, while accounting for subgroups’ diversity and, possibly, clinical relevance. Those subgroups are tested on independent data to assess their consistency across databases, while preserving statistical power by limiting the number of tests. To illustrate this algorithm, we applied it on the database of the International Diabetes Management Practice Study (IDMPS) to better understand the drivers of improved glycemic control and rate of episodes of hypoglycemia in type 2 diabetics patients. We compared Q-Finder with state-of-the-art approaches from both Subgroup Identification and Knowledge Discovery in Databases literature. The results demonstrate its ability to identify and support a short list of highly credible and diverse data-driven subgroups for both prognostic and predictive tasks.

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Switching From Pre-mixed Insulin to Regimens with Insulin Glargine in Type 2 Diabetes: A Prospective, Observational Study of Data From Adriatic Countries

Cited by 5 publications

References 20 publications

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

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

Twenty Years of Insulin Gla-100: A Systematic Evaluation of Its Efficacy and Safety in Type 2 Diabetes Mellitus

Q-Finder: An Algorithm for Credible Subgroup Discovery in Clinical Data Analysis — An Application to the International Diabetes Management Practice Study

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