Machine learning assessment of vildagliptin and linagliptin effectiveness in type 2 diabetes: Predictors of glycemic control
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SUBMITTER: Esaifan H
PROVIDER: S-EPMC11346939 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:IntroductionLinagliptin is a xanthine-based dipeptidyl peptidase (DPP)-4 inhibitor that is now available in numerous countries worldwide for the treatment of type 2 diabetes mellitus (T2DM). The aim of this study was to evaluate further the mechanisms underlying the improvements in glycemic control observed with linagliptin. The effects of linagliptin on DPP-4, pharmacodynamic parameters, and glycemic control versus placebo were assessed in patients with inadequately controlled T2DM.MethodsPatients in this phase 2a, multicenter, randomized, double-blind, placebo-controlled study received placebo (n = 40) or linagliptin 5 mg (n = 40). Sitagliptin 100 mg (n = 41) once daily for 4 weeks was included for exploratory purposes. Primary endpoints for linagliptin versus placebo: change from baseline to day 28 in 24-h weighted mean glucose (WMG) and intact glucagon-like peptide (GLP)-1 area under the time-effect curve between 0 and 2 h (AUEC(0-2h)) following meal tolerance test on day 28.ResultsLinagliptin increased intact GLP-1 AUEC(0-2h) (+18.1 pmol/h/L) and lowered 24-h WMG (-1.1 mmol/L) versus placebo (both P < 0.0001) after 28 days. Intact glucose-dependent insulinotropic polypeptide increased in line with GLP-1 (+91.4 pmol/h/L increase vs. placebo; P < 0.0001). Glycated hemoglobin (-0.22%; P = 0.0021), fasting plasma glucose (-0.6 mmol/L; P = 0.0283), and glucose (AUEC(0-3h)) (-5.9 mmol/h/L; P < 0.0001) improved significantly with linagliptin versus placebo. Most adverse events were mild; hypoglycemia or serious adverse events were not reported. Sustained DPP-4 inhibition (≥80%) throughout the treatment period was accompanied by significant reductions in glucagon starting at day 1 of linagliptin administration.ConclusionLinagliptin was well tolerated and effectively inhibited plasma DPP-4 activity in patients with T2DM, producing immediate improvements in incretin levels, glucagon suppression, and glycemic control that were maintained throughout the study period.
| S-EPMC3508116 | biostudies-literature
Project description:To review and summarize the current data for comparative effectiveness of glycemic control in older adults.In the last several years, professional societies have released guidelines for glycemic control in older adults, generally recommending individualized HbA1c goals. However, recent observational studies demonstrate that many older adults remain aggressively managed and are at increased risk of hypoglycemia. Large randomized trials of older adults with diabetes have failed to show cardiovascular benefit from intensive glycemic control and show only minimal microvascular benefit. Additionally, a few studies suggest that suboptimal glycemic control can increase the risk for geriatric syndromes. Emerging research suggests similar safety and efficacy of glucose-lowering therapies in older versus younger adults.Overall, there is a paucity of data supporting the benefit of intensive glycemic control in older adults. More research is needed in this vulnerable population.
| S-EPMC5585298 | biostudies-other
Project description:IntroductionTo assess real-world effectiveness of linagliptin in persons with type 2 diabetes mellitus (T2DM) across a range of ages and renal function. Effectiveness was assessed in different races, with a focus on African Americans (AA).MethodsThis was a non-interventional retrospective cohort study using data in the Optum clinical database from adults with T2DM initiating linagliptin. Date of the first linagliptin prescription was the index date. Outcomes included change in glycated hemoglobin (HbA1c) and the percentage of persons achieving an HbA1c < 7% (53 mmol/mol) during the 60-180 days following linagliptin initiation. Analyses of age by renal function were conducted. Multivariate regression analysis was performed to assess change in HbA1c, controlling for an a priori list of covariates.ResultsOverall, 11,001 persons were included. Mean pre-index HbA1c value was 8.2% (66 mmol/mol), with higher levels in younger versus older persons and AAs versus other race groups. Persons initiating linagliptin had an average HbA1c reduction of 0.51% (5.6 mmol/mol). Without adjusting for age, renal function, race, and pre-index HbA1c, greater reductions in HbA1c were observed in younger versus older persons, persons with higher versus lower estimated glomerular filtration rate (eGFR), and AAs versus white or Asians. After multivariate analysis, variables significantly associated with a greater HbA1c reduction included higher pre-index HbA1c and older age.ConclusionsThese results support the HbA1c-lowering effectiveness of linagliptin across age, race, and renal function categories among a large real-world population of adults with T2DM.
| S-EPMC7324460 | biostudies-literature
Project description:BackgroundProfessional guidelines recommend an HbA1c < 7% for most people with diabetes and < 8.5% for those with relaxed glycemic goals. However, many people with type 2 diabetes mellitus (T2DM) are unable to achieve the desired HbA1c goal. This study evaluated factors associated with lack of improvement in HbA1c over 3 years.MethodsAll patients with T2DM treated within a major academic healthcare system during 2015-2020, who had at least one HbA1c value > 8.5% within 3 years from their last HbA1c were included in analysis. Patients were grouped as improved glycemic control (last HbA1c ≤ 8.5%) or lack of improvement (last HbA1c > 8.5%). Multivariate logistic regression analysis was performed to assess independent predictors of lack of improvement in glycemic control.ResultsOut of 2,232 patients who met the inclusion criteria, 1,383 had an improvement in HbA1c while 849 did not. In the fully adjusted model, independent predictors of lack of improvement included: younger age (odds ratio, 0.89 per 1-SD [12 years]; 95% CI, 0.79-1.00), female gender (1.30, 1.08-1.56), presence of hypertension (1.29, 1.08-1.55), belonging to Black race (1.32, 1.04-1.68, White as reference), living in low income area (1.86,1.28-2.68, high income area as reference), and insurance coverage other than Medicare (1.32, 1.05-1.66). Presence of current smoking was associated with a paradoxical improvement in HbA1c (0.69, 0.47-0.99). In a subgroup analysis, comparing those with all subsequent HbA1c values > 8.5% (N = 444) to those with all subsequent HbA1c values < 8.5% (N = 341), similar factors were associated with lack of improvement, but smoking was no longer significant.ConclusionWe conclude that socioeconomic factors like race, type of insurance coverage and living in low-income areas are associated with lack of improvement in HbA1c over a period of 3-years in people with T2DM. Intervention strategies focused on low-income neighborhoods need to be designed to improve diabetes management.
| S-EPMC10809600 | biostudies-literature
Project description:The study explored the utility of four-point preprandial glucose self-monitoring to calculate several indices of glycemic control and variability in a study adding the DPP-4 inhibitor vildagliptin to ongoing insulin therapy. This analysis utilized data from a double-blind, randomized, placebo-controlled crossover study in 29 patients with type 2 diabetes treated with vildagliptin or placebo on top of stable insulin dose. During two 4-week treatment periods, self-monitoring of plasma glucose was undertaken at 4 occasions every day. Glucose values were used to assess several indices of glycemic control quality, such as glucose mean, GRADE, M-VALUE, hypoglycemia and hyperglycemia index, and indices of glycemic variability, such as standard deviation, CONGA, J-INDEX, and MAGE. We found that vildagliptin improved the glycemic condition compared to placebo: mean glycemic levels, and both GRADE and M-VALUE, were reduced by vildagliptin (P < 0.01). Indices also showed that vildagliptin reduced glycemia without increasing the risk for hypoglycemia. Almost all indices of glycemic variability showed an improvement of the glycemic condition with vildagliptin (P < 0.02), though more marked differences were shown by the more complex indices. In conclusion, the study shows that four-sample preprandial glucose self-monitoring is sufficient to yield information on the vildagliptin effects on glycemic control and variability.
| S-EPMC4637474 | biostudies-literature
Project description:Uncontrolled type-1 diabetes (T1DM) can lead to dyslipidaemia and albuminuria, which may promote cardiovascular injuries. However, some lipidemic factors could be useful in predicting cardiac dysfunction. Seventy-eight adolescents under insulin treatment due to a 6-year history of T1DM and were retrospectively examined. Glycemia, lipidemia, and albuminuria were measured in addition to development of cardiovascular abnormalities Both girls and boys showed higher HbA1c and fasting blood glucose and 27.1% females and 33.3% males exhibited microalbuminuria though their plasma levels of total cholesterol (TC), triglycerides (TG), and low-density lipoproteins (LDL) and high-density lipoproteins (HDL lipoproteins were in the normal range. They exhibited a preserved systolic function, but 50% of females and 66.6% of males had developed diastolic failures. Interestingly, girls with diastolic dysfunction showed significantly lower concentrations of HDL and higher TC/HDL and TG/HDL ratios. In fact, low HDL levels (OR 0.93; 95% CI 0.88-0.99; p = 0.029) and high TC/HDL (OR 2.55; 95% CI 1.9-5.45; p = 0.016) and TG/HDL (OR 2.74; 95% CI 1.12-6.71; p = 0.028) ratios associated with the development of diastolic complications. The cut-off values for HDL, TC/HDL, and TG/HDL were 49 mg/dL, 3.0 and 1.85, respectively. HDL and TC/HDL and TG/HDL ratios may be useful for predicting diastolic dysfunction in girls with uncontrolled T1DM.
| S-EPMC7404098 | biostudies-literature
Project description:Some adults with type 2 diabetes mellitus (T2DM) believe that chromium-containing supplements will help control their disease, but the evidence is mixed. This narrative review examines the efficacy of chromium supplements for improving glycemic control as measured by decreases in fasting plasma glucose (FPG) or hemoglobin A1c (HbA1c). Using systematic search criteria, 20 randomized controlled trials of chromium supplementation in T2DM patients were identified. Clinically meaningful treatment goals were defined as an FPG of ≤7.2 mmol/dL, a decline in HbA1c to ≤7%, or a decrease of ≥0.5% in HbA1c. In only a few randomized controlled trials did FPG (5 of 20), HbA1c (3 of 14), or both (1 of 14) reach the treatment goals with chromium supplementation. HbA1c declined by ≥0.5% in 5 of 14 studies. On the basis of the low strength of existing evidence, chromium supplements have limited effectiveness, and there is little rationale to recommend their use for glycemic control in patients with existing T2DM. Future meta-analyses should include only high-quality studies with similar forms of chromium and comparable inclusion/exclusion criteria to provide scientifically sound recommendations for clinicians.
| S-EPMC5009459 | biostudies-literature
Project description:This review aimed to evaluate the effectiveness of telemedicine as an intervention for patients with diabetes mellitus, considering blood glucose levels as the primary outcome. A comprehensive literature search was performed using the PubMed, Embase, Web of Science, and EBSCO databases. This narrative review covered randomized controlled trials published in English. The process of selecting studies adhered to the preferred reporting items for systematic reviews and meta-analyses guidelines. Nine studies were selected, and their data were analyzed and summarized. Five of the nine reviewed studies found that telemedicine counseling was effective in decreasing glycated hemoglobin A (HbA1c) levels in the blood. Due to methodological limitations, one study could not report HbA1c results, and two studies reported that telemedicine counseling did not lead to any significant changes in HbA1c levels. One study found that while HbA1c levels did not show a marked decrease, patients' treatment adherence and quality of life improved when telemedicine was combined with health counseling. Moreover, six studies found that telemedicine counseling was more effective than traditional counseling regarding secondary outcomes. The overall findings of this review suggest that telemedicine counseling is more effective than conventional counseling in achieving decreased blood glucose levels in patients with diabetes mellitus while increasing their treatment adherence and improving their quality of life.
| S-EPMC9726301 | biostudies-literature
Project description:IntroductionTo investigate whether vildagliptin add-on insulin therapy improves glycemic variations in patients with uncontrolled type 2 diabetes (T2D) compared to patients with placebo therapy.MethodsThis was a 24-week, single-center, double-blind, placebo-controlled trial. Inadequately controlled T2D patients treated with insulin therapy were recruited between June 2012 and April 2013. The trial included a 2-week screening period and a 24-week randomized period. Subjects were randomly assigned to a vildagliptin add-on insulin therapy group (n = 17) or a matched placebo group (n = 16). Scheduled visits occurred at weeks 4, 8, 12, 16, 20, and 24. Continuous glucose monitoring (CGM) was performed before and at the endpoint of the study.ResultsA total of 33 subjects were admitted, with 1 patient withdrawing from the placebo group. After 24 weeks of therapy, HbA1c values were significantly reduced at the endpoint in the vildagliptin add-on group. CGM data showed that patients with vildagliptin add-on therapy had a significantly lower 24-h mean glucose concentration and mean amplitude of glycemic excursion (MAGE). At the endpoint of the study, patients in the vildagliptin add-on group had a significantly lower MAGE and standard deviation compared to the control patients during the nocturnal period (0000-0600). A severe hypoglycemic episode was not observed in either group.ConclusionVildagliptin add-on therapy to insulin has the ability to improve glycemic variations, especially during the nocturnal time period, in patients with uncontrolled T2D.
| S-EPMC5630558 | biostudies-literature
Project description:The early prediction of diabetes can facilitate interventions to prevent or delay it. This study proposes a diabetes prediction model based on machine learning (ML) to encourage individuals at risk of diabetes to employ healthy interventions. A total of 38,379 subjects were included. We trained the model on 80% of the subjects and verified its predictive performance on the remaining 20%. Furthermore, the performances of several algorithms were compared, including logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), Cox regression, and XGBoost Survival Embedding (XGBSE). The area under the receiver operating characteristic curve (AUROC) of the XGBoost model was the largest, followed by those of the decision tree, logistic regression, and random forest models. For the survival analysis, XGBSE yielded an AUROC exceeding 0.9 for the 2- to 9-year predictions and a C-index of 0.934, while the Cox regression achieved a C-index of 0.921. After lowering the threshold from 0.5 to 0.25, the sensitivity increased from 0.011 to 0.236 for the 2-year prediction model and from 0.607 to 0.994 for the 9-year prediction model, while the specificity showed negligible changes. We developed a high-performance diabetes prediction model that applied the XGBSE algorithm with threshold adjustment. We plan to use this prediction model in real clinical practice for diabetes prevention after simplifying and validating it externally.
| S-EPMC9698354 | biostudies-literature