Number Of Oral Antidiabetic Drugs Research Articles

Exploring disparities: A comparative analysis of insulin-naïve, regular users, and inertia patients among type 2 diabetes mellitus outpatients in India

ABSTRACT Introduction: Insulin utilization pattern varies greatly in type 2 diabetes mellitus (T2DM) patients. Clinical inertia in treatment intensification hinders glycemic control in T2DM management. This study investigated insulin prescription trends and various predictors among insulin naive, user, and insulin inertia (II) patients in T2DM. Methodology: A retrospective analysis of T2DM patient records from the diabetes clinic at a tertiary care center was conducted. Data on socio-demographics, anthropometry, disease characteristics, comorbidities, adherence, and medication prescribing patterns were collected. Analysis was done using tests of significance, odds ratio (OR), and multivariate logistic regression. Results: A total of 950 records were analyzed, with 17.3% of patients identified as insulin users (IU), 70.9% being insulin-naïve (IN), and 11.8% having II. IUs had significantly higher glycemic levels including HbA1c, fasting, postprandial, and random blood sugars compared to the other groups. Higher HbA1c levels were associated with significantly increased odds of insulin usage (OR: 3.46, confidence interval (CI): 1.94–6.16), while individuals taking sulfonylureas had lower odds of insulin usage (OR: 0.27, CI: 0.08–0.91). A significant association was also seen with the total number of oral antidiabetic drugs prescribed (four drugs; OR: 15.6, and five drugs; OR: 9.1). Other factors did not show a significant association. The regression model showed HbA1c level as low as 7.9% could indicate a future insulin requirement in 22% of patients. Conclusion: The study outlines differences in characteristics and parameters among T2DM patients who require or do not require insulin and highlights the challenges in insulin initiation in Indian T2DM patients. Findings on II underscore the need for timely treatment intensification.

Severe hypoglycemia in patients with liver cirrhosis and type 2 diabetes.

Advanced liver disease with massive liver damage may affect the metabolism of hypoglycemic agents and increase the risk of hypoglycemia. We conduct this research to compare the risk of severe hypoglycemia between patients with type 2 diabetes, with and without compensated liver cirrhosis. From Taiwan's National Health Insurance Research Database, we identified persons with type 2 diabetes with cirrhosis (n = 18,209) and without cirrhosis (n = 538,510) from January 1, 2000, to December 31, 2010. Cox proportional hazards models were adopted to assess risks of all-cause mortality and severe hypoglycemia. The mean follow-up period of this study was 3.7 years. The incidence rates of death during follow-up were 26.54 and 2.75 per 1,000 patient-years [aHR 7.63 (6.70-8.70)] for patients with cirrhosis and without cirrhosis, respectively. The incidence rates of severe hypoglycemia during follow-up were 0.53 and 0.14 per 1,000 patient-years [aHR 2.74 (1.52-4.92)] for patients with and without cirrhosis, respectively. The subgroup analysis of hypoglycemia risks in patients with and without cirrhosis disclosed no significant interaction for variables such as age, sex, chronic kidney disease, sulfonylurea use, number of oral antidiabetic drugs, insulin, b-blocker, and fibrate. This cohort study demonstrated that patients with type 2 diabetes and compensated cirrhosis showed a higher risk of mortality and severe hypoglycemia than those without liver cirrhosis.

Effectiveness and safety of basal insulin therapy in type 2 diabetes mellitus patients with or without metformin observed in a national cohort in China

BackgroundThough many randomized control trials had examined the effectiveness and safety of taking insulin therapy with or without metformin, there are limited real-world data, especially among Chinese type 2 diabetes patients initiating basal insulin (BI) with uncontrolled hyperglycemia by oral agents. This study was designed to assess the effectiveness and safety of BI therapy combined with or without metformin in a real-world national cohort study.MethodsPatients with type 2 diabetes mellitus who initiated BI treatment due to uncontrolled hyperglycemia (HbA1c≥7 %) by oral antidiabetic drugs (OADs) were recruited in Chinese real-world settings between 2011 and 2013. A total of 12,358 patients initiated BI without bolus insulin and completed a 6-month follow-up were selected as the study population and divided into BI with metformin or BI without metformin group based on whether metformin was simultaneously prescribed or not at baseline. Propensity score adjustment was used to balance baseline covariates between two groups. A sub-analysis was also conducted among 8,086 patients who kept baseline treatment regimen during the follow-up. Outcomes were HbA1c, hypoglycemia, weight gain and insulin dose in two groups.Results53.6 % (6,621 out of 12,358) patients initiated BI therapy concomitant with metformin. After propensity score adjustment, multivariate regression analysis controlled with number of OADs, total insulin dose, physical activity and diet consumption showed that BI with metformin group had a slightly higher control rate of HbA1c <7.0 % (39.9 % vs. 36.4 %, P = 0.0011) at 6-month follow-up, and lower dose increment from baseline to 6-month (0.0064 vs. 0.0068 U/day/kg, P = 0.0035). The sub-analysis with patients remained at same BI therapy further showed that BI with metformin group had higher HbA1c control rate (47.9 % vs. 41.9 %, P = 0.0001), less weight gain (-0.12 vs. 0.15 kg P = 0.0013), and lower dose increment during 6-month follow-up (0.0033 vs. 0.0037 U/day/kg, P = 0.0073) when compared with BI without metformin group.ConclusionsIn alliance with current guidelines, the real-world findings also support the insulin initiation together with metformin. Continuous patients’ education and clinicians training are needed to improve the use of metformin when initiating BI treatment.

A Real-World Observational Study Evaluating the Probability of Glycemic Control with Basal Insulin or Glucagon-Like Peptide-1 Receptor Agonist in Japanese Patients with Type 2 Diabetes.

IntroductionThe effectiveness of basal insulin (BI) or glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in providing glycemic control in patients with type 2 diabetes (T2D) in Japanese routine practice is not well known. This real-world observational study evaluated the probability of achieving glycemic control in Japanese patients with T2D uncontrolled by oral antidiabetic drugs (OADs) who initiated BI or GLP-1 RA therapy.MethodsPatients with T2D aged ≥ 18 years initiating BI or GLP-1 RA therapy following treatment with OADs were selected from real-world data (RWD) retrieved from a large electronic medical record database in Japan, using data from 01 January 2010 to 30 June 2019. Patients were required to have glycated hemoglobin (HbA1c) ≥ 7% within 90 days prior to the first prescription of BI or GLP-1 RA. The probability of reaching first HbA1c < 7% was assessed over a 24-month period in cohorts of patients who initiated BI (n = 3477) or GLP-1 RA (n = 780) and in subcohorts by number of OADs at baseline (1, 2, or ≥ 3), HbA1c at baseline (≥ 7 to < 8%, ≥ 8 to < 9%, or ≥ 9%), and age (< 65 or ≥ 65 years).ResultsMean (standard deviation) baseline HbA1c was 9.4% (1.8%) and 8.8% (1.4%) in patients initiating BI or GLP-1 RA therapy, respectively. The cumulative probability of achieving glycemic control was 50.1% with BI and 60.3% with GLP-1 RA therapy, respectively, at 12 months, and 60.8% and 66.6%, respectively, at 24 months. Quarterly (3-month intervals) conditional probabilities of achieving glycemic control decreased over time and were < 10% after 12 months. Patients with more OADs or higher HbA1c at baseline had a lower probability of achieving glycemic control.ConclusionAmong Japanese patients with T2D who initiated BI or GLP-1 RA therapy after treatment with OADs, the probability of reaching first glycemic control diminished over time. Further therapy intensification is warranted in patients who do not achieve glycemic control within 6–12 months with BI or GLP-1 RA, particularly those with high HbA1c or taking multiple OADs.Electronic supplementary materialThe online version of this article (10.1007/s13300-020-00836-8) contains supplementary material, which is available to authorized users.

Late Conversion From Calcineurin Inhibitors to Belatacept in Kidney-Transplant Recipients Has a Significant Beneficial Impact on Glycemic Parameters.

Background.Calcineurin inhibitors (CNIs) and steroids are strongly associated with new-onset diabetes after transplantation, worsening of pre-existing diabetes, and cardiovascular events. We assessed the benefit of conversion from CNI-based to belatacept-based immunosuppression in diabetic kidney-transplant (KT) recipients on glucose control and cardiovascular risk factors.Methods.In this retrospective, noncontrolled single-study conducted between May 2016 and October 26, 2018, we recruited KT recipients converted from CNIs to belatacept at least 6 months after KT. The primary endpoint was the evolution of hemoglobin A1c (HbA1c) between baseline and after 6 months of treatment. Secondary endpoints included modifications to antidiabetic drugs, other cardiovascular risk factors, and renal function.Results.One hundred and three KT recipients were included. Of these, 26 (25%) had type 2 diabetes. The patients were either receiving oral antidiabetic drugs (n = 21; 75%) or insulin therapy (n = 14; 54%). Overall HbA1c decreased significantly from 6.2 ± 1 to 5.8 ± 1%, P < 0.001. In diabetic patients, HbA1c decreased from 7.2 ± 1 to 6.5 ± 1%, P = 0.001. HbA1c significantly decreased in the subgroup of patients with new-onset diabetes after transplantation and whether diabetes was controlled at inclusion or not (ie, HA1c ≤7% or >7%). Moreover, no diabetic patient increased the number of oral antidiabetic drugs and the dose of basal insulin was not statistically different from baseline to 6 months (16 international unit at baseline and 16 international unit at 6 mo, P = 1). One patient had to start treatment by insulin pump. During follow-up, the renal function, body mass index, and hemoglobin level of all 103 patients remained stable, 2 patients presented acute cellular rejection, and no patient suffered from graft loss.Conclusions.A late switch from CNI to belatacept was a valuable therapeutic option for diabetic kidney recipients and substantially improved glycemic parameters.

1248-P: Estimating Diabetes Duration from Electronic Medical Records (EMRs) with an Intrinsic Diabetes Risk Prediction Model: From Clinical Trial to Real-World Clinical Practice

We have previously described the utility and high predictive value of the Building, Relating, Assessing, and Validating Outcomes (BRAVO) model, which was developed from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial data. However, it uses diabetes duration as a key factor for modelling diabetes progression, and diabetes duration is not routinely collected in EMRs. This study use machine learning to estimate diabetes duration with EMR information. Among individuals (N=8,026) with complete records from the ACCORD trial, diabetes duration was estimated with an ordinary least squares (OLS) model, a least absolute shrinkage and selection operator (LASSO) model, a pruned decision tree model, and a random forest model using 37 baseline predictors such as biomarkers, demographics, disease history, and medications. Model performance was compared using root-mean-square Error (RMSE), mean-absolute error (MAS), and R-squared. All three indicators were calculated through 10-fold cross-validation with 1000 iterations in order to address over-fitting. Age, current HbA1c value, retinopathy, number of oral antidiabetic drugs, number of Insulin types, and use of sulfonylureas were identified as key predictors for patient-reported diabetes duration. The random forest model achieved the best performance on all three indicators (RMSE=6.16, MAE= 4.71, R2=0.30), significantly higher than the pruned decision tree model (RMSE=6.57, MAE= 5.03, R2=0.21) and LASSO model (RMSE=6.60, MAE= 5.08, R2=0.20). Diabetes duration can be predicted using fields routinely included in EMRs. Integration of the results of this prediction equation into predictive diabetes models (such as BRAVO) will allow patient-specific estimates of diabetes duration based solely on EMRs. This will increase precision when inferring risk level and using models to aid clinical decision making among patients with type 2 diabetes. Disclosure H. Shao: None. S. Yang: None. C. Stoecker: None. V. Fonseca: Board Member; Self; American Association of Clinical Endocrinologists. Consultant; Self; Abbott, Asahi Kasei Corporation, Novo Nordisk Inc., Sanofi US, Takeda Pharmaceutical Company Limited. Research Support; Self; Bayer US. Stock/Shareholder; Self; Amgen Inc., BRAVO4HEALTH, Mellitus Health. X. Cheng: None. L. Shi: None.

Glycosylated hemoglobin level and number of oral antidiabetic drugs predict whether or not glycemic target is achieved in insulin-requiring type 2 diabetes

AimsFactors predicting success (glycosylated hemoglobin (A1C)<7%) with insulin therapy in patients with insulin-requiring type 2 diabetes need to be identified. MethodsA retrospective, multi-center, observational study was conducted for outpatients with oral antidiabetic drug (OAD)-treated type 2 diabetes whose A1C levels remained above 7%. Patients were begun on basal insulin between January 2005 and December 2006. Biochemical variables and demographic data were collected before and after 52 weeks of insulin therapy. ResultsA total of 565 patients (age, 60.4±11.9 years; A1C levels, 10.11 ±1.81%; duration of diabetes, 11.5±6.8 years) were studied. By study end, 63 patients (11.2%) had achieved the glycemic goal (A1C<7%). The glycemic goal attainment rate was only 9.1% in patients with A1C>8.8% and who were taking >2 OADs at baseline. The highest rate (32.7%) of successful glycemic control was observed in the group of patients with A1C ≤ 8.8% and who used ≤ 2 OADs at baseline. ConclusionsInsulin-naïve diabetic patients with A1C>8.8%, especially those who are taking >2 OADs, have small chance to achieve good glycemic control with adding only basal insulin therapy.

Insulin usage in type 2 diabetes mellitus patients in UK clinical practice: a retrospective cohort-based analysis using the THIN database

This retrospective cohort-based study assessed the change in glycated haemoglobin A1C (HbA 1C) in patients with type 2 diabetes, with existing prescriptions for oral antidiabetic drugs (OADs), prescribed insulin versus those prescribed subsequent OADs. A cohort of patient records drawn from the The Health Improvement Network (THIN) database was stratified by maximum concurrent number of OADs. Of 128,568 unique patient records identified, 67.7% (n=87,057) had received at least one OAD, 17.4% (n=15,138) of these patients progressed to insulin therapy. Mean HbA1C at insulin initiation was 9.5% (one OAD), 9.6% (two), 9.7% (three) and 10.1% (four), with an average HbA 1C increase of 0.7% prior to insulin initiation. The greatest improvement in HbA1C was achieved with insulin therapy. A threshold HbA 1C value of 8.5% above which OAD escalation is unlikely to achieve a target HbA1C ≤ 7.0% is seen. In patients not achieving HbA1C targets with OADs only, insulin-based regimens should be considered in preference to adding more or multiple OADs. Br J Diabetes Vasc Dis 2010;10:178—182.