Achieving HbA1c Goals Research Articles

Optimal dosing of gliclazide - a model-based approach.

Gliclazide was approved as a treatment for type 2 diabetes in an era before model-based drug development and consequently the recommended doses were not optimized with modern methods. To investigate various dosing regimens of gliclazide, we used publicly available data to characterise the dose-response relationship using pharmacometric models. A literature search identified 21 published gliclazide pharmacokinetic (PK) studies with full profiles. These were digitized and a PK model was developed for immediate- (IR) and modified-release (MR) formulations. Data from a gliclazide dose-ranging study of postprandial glucose were used to characterise the concentration-response relationship, using the integrated glucose-insulin model. Simulations from the full model showed that the maximum effect was 44% of the patients achieving HbA1c<7 % with 11% experiencing glucose<3 mmol/L and the most sensitive patients (i.e., 5% most extreme) experiencing 35 min of hypoglycaemia. Simulations revealed that the recommended IR dose (320 mg) was appropriate with no efficacy gain with increased dose. However, the recommended dose for the MR formulation may be increased to 270 mg, with more patients achieving HbA1c goals (i.e., HbA1c<7%) without a hypoglycaemic risk higher than the resulting risk from the recommended IR dose.

Impact of pharmacist participation in the patient care team on value-based health measures.

To evaluate whether pharmacist engagement on the interdisciplinary team leads to improved performance on diabetes-related quality measures. This was a retrospective observational study of patients seen in primary care and specialty clinics from October 2014 to October 2020. Patients were included if they had a visit with a physician, nurse practitioner, physician's assistant, or clinical pharmacist practitioner (CPP) within the study period and had a diagnosis of diabetes. The intervention group included patients with at least one visit with a CPP, while the control group consisted of patients who were exclusively managed by non-CPP providers. The primary outcome of this study was the median change in glycosylated hemoglobin (HbA1c) from baseline to follow-up at 3, 6, and 12 months. The secondary outcome was the probability of achieving the HbA1c targets of <7% and <8% at 3, 6, and 12 months. Patients referred to a CPP had higher HbA1c levels at baseline and were more likely to have concomitant hypertension (P < 0.01). Patients seen by a CPP had 0.31%, 0.41%, and 0.44% greater reductions in HbA1c compared to patients in the control group at 3, 6, and 12 months, respectively (P < 0.01). Patients managed by a CPP were also more likely to achieve the identified HbA1c targets of <7% and <8%. Patients referred to a CPP were more complex, but had greater reductions in HbA1c and were more likely to achieve HbA1c goals included in the organization's quality measures. This study demonstrates the value of pharmacists in improving patient care and their role in supporting an organization's achievement of value-based quality measures.

Development and validation of the self-management Barriers and Supports Evaluation for working-aged adults with type 1 diabetes mellitus

IntroductionTo optimize type 1 diabetes mellitus self-management, experts recommend a person-centered approach, in which care is tailored to meet people’s needs and preferences. Existing tools for tailoring type 1 diabetes...

Individualized HbA1c Goals, and Patient Awareness and Attainment of Goals in Type2 Diabetes Mellitus: A Real-World Multinational Survey.

AimsWhile glycemic control is key in effective type 2 diabetes mellitus management, many patients fail to reach their individualized glycemic goal. This analysis aimed to describe a real-world picture of diabetes management: individualized hemoglobin A1c (HbA1c) goals, rate of goal attainment, HbA1c at each line of therapy, and patient awareness of their glycemic goal. Secondly, we aimed to understand physician satisfaction with HbA1c amongst patients aware vs. those unaware of HbA1c goal.MethodsAnalysis of physicians and the next ten consulting patients with type 2 diabetes mellitus conducted in Europe and the USA including medical record data abstraction/assessment by physicians, a patient-reported survey and a physician survey. Patients were diagnosed for 3 months or more with a known current and target HbA1c. For the sub-analysis assessment of patient awareness of HbA1c goal, in addition to the above, these patients had to have completed a patient-reported questionnaire and answer the question on awareness of HbA1c goal.ResultsA total of 730 physicians provided data on 8794 patients with type 2 diabetes mellitus; 5331 patients were eligible for this analysis. Overall, mean (standard deviation, SD) individualized HbA1c goal was 6.8% (0.68%). Of eligible patients, 39.1% met their HbA1c goal; of 60.9% of patients not reaching their HbA1c goal, the mean distance from individualized HbA1c goal was 0.9% (SD 1.0%). Physicians progressed patients’ antihyperglycemic therapy when HbA1c was 8% or higher. Among 2560 patients who were included in the sub-analysis assessing the effect of patient awareness of their HbA1c goal on multiple parameters, 70.5% were aware of their HbA1c goal; mean HbA1c goal was 6.8% (0.7%) and current mean HbA1c value 7.1% (1.2%). A total of 949 patients in the sub-analysis (39.2%) achieved their goal; achieving HbA1c goal was not related to knowledge of goal. Patients aware of their HbA1c goal were slightly more adherent to their antihyperglycemic medication. They also were prescribed more antihyperglycemic agents, more often on a later therapy line receiving a GLP-1 receptor agonist, SGLT2i, or insulin, and more often tested their blood glucose levels than patients who were unaware. Physicians were not satisfied with the current blood glucose level of one third of their patients, believing that more of those who were aware of their HbA1c goal could achieve better glucose control (32.4% of aware vs. 28.2% of unaware patients; p = 0.003).ConclusionsOur results showed that the proportion of patients with type 2 diabetes mellitus achieving their goals for glycemic control was suboptimal when compared to current guideline criteria, with only about 40% of patients achieving their individualized HbA1c goal. Treatment intensification was often delayed until HbA1c was 8% and higher. Patients aware of their HbA1c goal were slightly more adherent to their antihyperglycemic medication; however, awareness of HbA1c goal did not enhance goal attainment. This highlights the need for a holistic approach to diabetes management, involving patient education, and patient–physician communication and partnership.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01985-3.

Can Innovative Technologies Overcome HbA1c Disparity for African-American Youth with Type 1 Diabetes?

Achieving normal or near-normal glycemic control as reflected by HbA1c levels in patients with type 1 diabetes (T1D) is important for preventing the development and progression of chronic complications. Despite delineation and dissemination of HbA1c management targets and advances in insulin pharmacology, insulin delivery systems, and glucose monitoring, the majority of children with T1D do not achieve HbA1c goals. In particular, African Americans are more likely not to reach HbA1c goals and have persistently higher HbA1c than Non-Hispanic Whites. Availability of pumps and other technology has not eliminated the disparity in HbA1c. Multiple factors play a role in the persisting racial disparity in HbA1c outcome. The carefully designed application and deployment of new technology to help the patient/family and facilitate the supportive role of the diabetes management team may be able to overcome racial disparity in glycemic outcome and improve patient quality of life.

Sotagliflozin added to optimized insulin therapy leads to HbA1c reduction without weight gain in adults with type 1 diabetes: A pooled analysis of inTandem1 and inTandem2.

To evaluate whether the addition of sotagliflozin to optimized insulin significantly increases the proportion of adults with type 1 diabetes who achieve HbA1c goals without weight gain. In a patient-level pooled analysis (n = 1575) of data from two phase 3, 52-week clinical trials (inTandem1 and inTandem2), the change from baseline in HbA1c and weight as well as the proportion of participants achieving an HbA1c of less than 7% without weight gain were compared between groups treated with placebo, sotagliflozin 200 mg and sotagliflozin 400 mg. From a mean baseline HbA1c of 7.7%, mean HbA1c changes at week 24 were -0.36% (95% CI -0.44% to -0.29%) and -0.38% (-0.45% to -0.31%) with sotagliflozin 200 and 400 mg versus placebo (P = .001 for both), respectively, with sustained effects through week 52. Weight significantly decreased at weeks 24 and 52 in both sotagliflozin groups compared with placebo. At week 52, the proportion of patients who achieved an HbA1c of less than 7% without weight gain was 21.8% with sotagliflozin 200 mg, 26.1% with sotagliflozin 400 mg and 9.1% with placebo (P < .001). Other HbA1c, weight and safety composite variables showed similar significant trends. When added to optimized insulin therapy, sotagliflozin improved glycaemic control and body weight and enabled more adults with type 1 diabetes to achieve HbA1c goals without weight gain over 52 weeks, although there was more diabetic ketoacidosis relative to placebo.

1028-P: Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL (gla-300) in Insulin-Naïve Patients with Type 2 Diabetes (T2DM): Interim Analysis of the ATOS Study

ATOS is a prospective, 12-month, observational study assessing real-world effectiveness of the second-generation basal insulin analog Gla-300 in emerging markets. Insulin-naïve adults (≥18 years) with T2DM, HbA1c &amp;gt;7-≤11 % and previously treated with ≥1 oral antihyperglycemic drug were recruited in 18 countries. An interim analysis was undertaken when ≥50% of participants had 6-months’ follow-up data (cut-off July 1, 2019); this included 4527 eligible patients (Eastern Europe: 1748; Egypt: 214; India: 1269; Latin America and Caribbean: 317; Western Asia: 882; Southeast Asia: 46; Taiwan: 51). Mean (SD) age was 57.2 (10.8) years, BMI was 29.4 (5.3) kg/m2, and duration of diabetes was 10.2 (6.2) years; 48.4% were male. Physician-set individualized HbA1c (%) goals at baseline were &amp;lt;7: 13.7%; 7-&amp;lt;7.5: 70.3%; 7.5-&amp;lt;8: 11.9%; ≥8: 4.2%. The proportion of evaluable patients achieving HbA1c goal at Month 6 (primary outcome) was 25.1% (95% CI: 23.6 to 26.6); HbA1c decreases are shown in Table. Hypoglycemia incidence was low (&amp;lt;2%). Treatment-emergent adverse events (TEAEs) were reported in 230 (5.0%) patients, with 47 (1.0%) serious TEAEs (included population). ATOS showed high baseline HbA1c, suggesting delayed insulin initiation; introduction of Gla-300 led to marked improvements in HbA1c with a good safety profile in a real-world setting. Disclosure G.R. Galstyan: None. A. Bhansali: None. H. Vargas-Uricoechea: Speaker’s Bureau; Self; Sanofi-Aventis. A. Tirosh: Advisory Panel; Self; Novo Nordisk Inc., Sanofi. G. Sun: None. M. Naqvi: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. M. Coudert: Employee; Self; Roche Pharma, Sanofi-Aventis. D. Cherkasov: None. N. Khan: None. Funding Sanofi (ATOS/NCT03703869)

1209-P: A Quality Improvement Initiative to Increase Utilization of Continuous Glucose Monitors Results in Improved Glycemic Outcomes in a Pediatric Diabetes Clinic

A minority of youth with type 1 diabetes (T1D) achieve HbA1c goals recommended by the ADA. Continuous glucose monitoring (CGM) is shown to improve glycemic control and reduce complications of disease. Despite this evidence, CGM utilization is low among youth with T1D. In this quality improvement project, we aimed to increase percentage utilization of CGM amongst our pediatric T1D clinic population from a baseline mean of 9% in 2017. Targeted interventions to achieve this goal included identification and tracking of utilizers vs. non-utilizers, creation of a standardized clinic workflow to initiate a new CGM device within the EMR, and identification of barriers to insurance coverage. CGM utilization in our pediatric T1D clinic increased from a mean 9% in 2017 to 53% in 2019. Over this same period, our clinic observed a 7% increase in patients who achieved goal HbA1c. Targeted interventions to increase CGM utilization in a pediatric T1D clinic secondarily led to improved glycemic outcomes. Disclosure K. Obrynba: None. J.A. Indyk: None. K. Gandhi: None. D.A. Buckingham: None. T. Wells: None. W.N. Wayne: None. M.K. Kamboj: Research Support; Self; Type 1 Diabetes TrialNet, Unitio, Inc.

Differences in Achieving Hba1C Goals Among Patients Seen by Endocrinologists and Primary Care Providers

Objective: This study evaluated whether there is a difference in the proportion of patients with type 2 diabetes who achieve a hemoglobin A1c (HbA1c) <7% within one year following treatment by an endocrinologist or primary care physician (PCP). Methods: We conducted a retrospective, propensity-matched study of patients with type 2 diabetes that were not optimally controlled and seen within our health system from 2007-2016. We assessed differences in short term health outcomes for patients following an endocrinologist visit compared to a PCP visit. Results: Patients seen by endocrinologists obtained HbA1c control at a faster rate (hazard ratio = 1.226; 95% confidence interval = 1.01 to 1.488) than those seen by a PCP. Furthermore, 34.5% and 29.5% of those treated by endocrinologists and PCPs, respectively, obtained HbA1c control by one year. Endocrinologists were more likely to prescribe a new medication class within 90 days than PCPs (14.1% versus 10.3%, respectively, P = .043). There was no difference in the risk of hospitalization between groups; 24.4% and 24.1% of those treated by endocrinologists and PCPs, respectively, were hospitalized within one year. Conclusion: Patients treated by endocrinology specialists were more likely to achieve a target HbA1c of <7% (53 mmol/mol) than those treated by PCPs in our health-care system. The performance difference may be partially explained by a higher rate of adding new classes of diabetes medications to the patient's pharmacologic regimens within 90 days by endocrinologists compared with PCPs. The long-term impact of these differences is unknown but has the potential to have an unfavorable impact on the health of the population. Abbreviations: ACP = American College of Physicians; CI = confidence interval; DUHS = Duke University Health System; HbA1c = hemoglobin A1c; HR = hazard ratio; PCP = primary care physician; SMD = standard mean difference.

PDB16 TRENDS IN THE QUALITY OF DIABETES CARE IN THE UNITED STATES: THE NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY (NHANES), 1999 TO 2016

To examine national trends over the past 18 years in the quality of diabetes care among US adults with diabetes. Individuals with diabetes aged 20 years or older from NHANES (1999 -2016) were included in the analysis. Quality indicators for diabetes care included Hemoglobin A1c (HbA1c) < 8%, Blood Pressure (BP) < 130/80 mmHg, Low-Density Lipoprotein (LDL-C) < 100 mg/dL, triglycerides < 150 mg/dL, receipt of eye and foot examinations in the past year, and meeting with a diabetes educator in the past year. A total of 7,521 adults with diabetes were identified. The study sample was found to be predominantly old (mean age = 62.8 years), male (51.2%), Whites (61.0%), and with some form of health insurance (87.8%). During The study period, the overall quality of diabetes care was found to have significantly improved in the study sample. This improvement was observed in achieving HbA1c goal (from 71.9% to 79.9%; Ptrend <0.0001), BP control (from 42.3% to 51.2%; Ptrend=0.0003), LDL-C goal (from 31.9% to 52.5%; Ptrend=0.0001), triglycerides goal (from 45.4% to 58.8%; Ptrend=0.00095), and meeting a diabetes educator (from 35.6% to 40.8%; Ptrend=0.0132). Blacks and Hispanics experienced significant increase in rates of achieving most treatment goals over the 18-year study period. However, by the last survey cycle (2015-2016), substantial disparities in the quality of diabetes care persisted between Whites and these minority groups. Furthermore, lack of health insurance, lower educational attainment and presence of obesity and chronic kidney disease were found to be strong predictors of quality of diabetes care. The quality of diabetes care in US adults has experienced substantial improvement in the past few decades. Nevertheless, gaps between certain minority groups and Whites still remain a critical issue. Future studies should explore all aspects of these disparities to improve outcomes of diabetes care.

Assessment of Safety and Effectiveness of Glaritus&amp;lt;sup&amp;gt;&amp;amp;reg;&amp;lt;/sup&amp;gt; (Wockhardt’s Insulin Glargine) in a Prospective, Multi-Centric Post Marketing Observational Study in Nepalese Having Type 2 Diabetes Mellitus

Background: Nepal is one of the fastest urbanizing countries in South Asia and is facing the consequences of urban lifestyle leading to obesity and metabolic syndrome. Type 2 diabetes mellitus (T2DM) is currently a high-burden disease in Nepal with a prevalence of 8.4%. Of these 8% - 18% patients are on insulin and 42% patients were reported to have uncontrolled diabetes in the past year. This suggests a need for better therapy options in terms of efficacy and safety. The current study was designed to investigate the effects of Insulin glargine-based therapy in Nepalese with T2DM who could not achieve adequate glycemic control with oral and non-glargine-insulin therapy. Methods: This is a prospective, multi-centric, single arm and post marketing observational study to assess the safety and effectiveness of Glaritus® (Wockhardt’s Insulin Glargine) in 52 T2DM patients from 3 (three) different study sites in Nepal (Bharatpur, Kathmandu and Pokhra) from September 2015 to December 2016. The primary objective of the study was to evaluate the safety of Glaritus®, mainly in terms of hypoglycemia, renal function tests and liver function tests. The secondary objectives were to evaluate the effectiveness of Glaritus® in terms of percentage of patients achieving HbA1c goal of less than 7%, mean changes in HbA1c & fasting plasma glucose (FPG) levels from baseline till the end of study. Results: 3.85% of subjects experienced hypoglycemia during first 3 months of therapy whereas 1.92% had similar experience in next 3 months of therapy. The mean HbA1c values reduced from 9.16% to 7.15% at the end of study. 21.05% of the enrolled subjects achieved the goal of HbA1c < 7% at the end of 3 months of therapy, whereas 52.5% achieved the target HbA1c at the end of 6 months of therapy. The mean FPG value of study population reduced from 239.94 mg/dl to 151.31 mg/dl at the end of study. There was no significant change in renal or liver functions during treatment. None of the subjects experienced any other adverse event (AE), thus indicating that Glaritus® was well tolerated by the study patients. Conclusion: In patients with type 2 diabetes mellitus inadequately controlled on oral hypoglycemic agents and/or insulin, initiation with Glaritus® significantly improved glycemic control with good tolerability and acceptability. This analysis in T2DM Nepalese patients shows that by significantly improving glycemic control while not increasing risk of hypoglycemia, Glaritus® provides safer basal insulin and may be suited to aggressive treatment regimens. From a societal perspective, it will help more patients reach the glycemic control target as recommended by the current treatment guidelines.

Self-Managed Titration with Insulin Glargine 300 U/mL (Gla-300) Can Achieve Similar Efficacy to Physician-Led Titration Regardless of Prior Insulin Status in People with T2DM—Results from TAKE CONTROL

Many people with T2DM do not achieve HbA1c goals in clinical practice, owing in part to sub-optimal basal insulin titration. TAKE CONTROL, a 24-week, multicenter, randomized, open-label, parallel-group study, compared the efficacy and safety of a Gla-300 titration algorithm (fasting self-monitored plasma glucose &amp;gt;130 mg/dL, +3 U; &amp;lt;80 mg/dL, −3 U), when self-managed or led by physicians. Overall, improved glycemic control without increased hypoglycemia was seen with self-titration. Here, we report results stratified by prior insulin use. At baseline, mean HbA1c was higher in the insulin-naïve vs. prior-insulin group (Table). In both groups, self-titration and physician-led titration resulted in similar HbA1c reduction. For confirmed or severe hypoglycemia, there was no evidence of heterogeneity between titration approaches for both glycemic thresholds (≤70 mg/dL or &amp;lt;54 mg/dL). Glycemic goal achievement with Gla-300 using self-titration was similar to that reported for physician-led titration, regardless of prior insulin use, but with reduced or similar risk of hypoglycemia. Empowering people with T2DM to self-titrate their basal insulin effectively upon Gla-300 initiation, or after switching to Gla-300, can improve glycemic target achievement without increasing hypoglycemia. Disclosure E. Delgado: Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S. Advisory Panel; Self; Sanofi-Aventis. Speaker's Bureau; Self; Sanofi-Aventis. Research Support; Self; Sanofi-Aventis. Speaker's Bureau; Self; Esteve, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Lilly. Research Support; Self; Menarini Group. M. Bonnemaire: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. A. Dauchy: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. V. Donicova: None. M. Kvapil: None. N. Tentolouris: Advisory Panel; Self; MSD K.K., AstraZeneca, Sanofi, Novo Nordisk A/S, Elpen Pharmaceutical Co. Inc., Eli Lilly and Company, Boehringer Ingelheim GmbH, Novartis AG. Research Support; Self; MSD K.K., Eli Lilly and Company, Novo Nordisk A/S, Sanofi, Pfizer Inc., AstraZeneca, Janssen-Cilag Pty Limited, GlaxoSmithKline plc., Novartis AG. L. Popescu: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. D. Russell-Jones: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim, Cellnovo, Eli Lilly and Company, Novartis, Novo Nordisk, Sanofi.

Self-Titration with Insulin Glargine 300 or 100 U/mL has Improved Efficacy vs. Physician-Led Titration—Comparison of the TAKE-CONTROL, AT.LANTUS, and ATLAS Studies in People with Type 2 Diabetes (T2DM)

Empowering individuals to self-titrate their basal insulin may help to reduce rates of sub-optimal titration often observed in clinical practice and help more people achieve HbA1c goals. Here we compare the results from the recently completed TAKE CONTROL study, which evaluated self-titration and physician-led titration of insulin glargine 300 U/mL (Gla-300) in people with T2DM, with comparable studies (AT.LANTUS and ATLAS) of insulin glargine 100 U/mL (Gla-100). All 3 studies were 24-week, multicenter, randomized, open-label, parallel-group studies. Fasting blood glucose targets were 80-130 mg/dL (4.4-7.2 mmol/L) in TAKE CONTROL, ≤100 mg/dL (5.5 mmol/L) in AT.LANTUS and ≤110 mg/dL (6.1 mmol/L) in ATLAS. Mean baseline HbA1c was between 8.4 and 8.9% (Table). Self-titration statistically significantly lowered mean HbA1c by 0.97 to 1.40% vs. physician-led titration (0.84 to 1.25%; p&amp;lt;0.for all 3 studies). The incidence of severe hypoglycemia and other safety outcomes was similar between titration arms in all 3 studies (Table). Both Gla-300 and Gla-100 were effective in improving glycemic control. Self-titration with Gla-300 resulted in significantly improved glycemic control vs. physician-led titration, as demonstrated previously with Gla-100, without increased hypoglycemia. Disclosure M. Davies: Advisory Panel; Self; AstraZeneca. Board Member; Self; AstraZeneca. Consultant; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Board Member; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Advisory Panel; Self; Eli Lilly and Company. Board Member; Self; Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Board Member; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Board Member; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Board Member; Self; Sanofi-Aventis. Consultant; Self; Sanofi-Aventis. Research Support; Self; Sanofi-Aventis. Advisory Panel; Self; Sanofi-Aventis. Speaker's Bureau; Self; Sanofi-Aventis. Advisory Panel; Self; Servier. Consultant; Self; Intarcia Therapeutics, Inc.. Speaker's Bureau; Self; Mitsubishi Tanabe Pharma Corporation. E. Boelle-Le Corfec: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. M. Bonnemaire: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. M. Odawara: Speaker's Bureau; Self; Sanofi, Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; Eli Lilly and Company. Advisory Panel; Self; Sanofi, Novo Nordisk Inc., Eli Lilly and Company. L. Popescu: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J. Sieber: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. D. Russell-Jones: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim, Cellnovo, Eli Lilly and Company, Novartis, Novo Nordisk, Sanofi. K. Strojek: Research Support; Self; AstraZeneca. Other Relationship; Self; Sanofi-Aventis, Novo Nordisk A/S. Speaker's Bureau; Self; Servier, Eli Lilly and Company, MSD K.K., Boehringer Ingelheim GmbH. Research Support; Self; Pfizer Inc., Amgen Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc. N. Tentolouris: Advisory Panel; Self; MSD K.K., AstraZeneca, Sanofi, Novo Nordisk A/S, Elpen Pharmaceutical Co. Inc., Eli Lilly and Company, Boehringer Ingelheim GmbH, Novartis AG. Research Support; Self; MSD K.K., Eli Lilly and Company, Novo Nordisk A/S, Sanofi, Pfizer Inc., AstraZeneca, Janssen-Cilag Pty Limited, GlaxoSmithKline plc., Novartis AG.

Abstract #1210 Sotagliflozin Further Improves Percentage of Patients Achieving HBA1C Goal Without Weight Gain in Adults with Type 1 Diabetes (T1d) After Insulin Therapy Optimization

Abstract #1210 Sotagliflozin Further Improves Percentage of Patients Achieving HBA1C Goal Without Weight Gain in Adults with Type 1 Diabetes (T1d) After Insulin Therapy Optimization

Ethnic Differences in Efficacy and Safety of Alogliptin: A Systematic Review and Meta-Analysis.

IntroductionAlogliptin is a highly selective, potent, and orally available dipeptidyl peptidase-4 (DPP-4) inhibitor. This study compared the glucose-lowering efficacy and safety of alogliptin between Asian and non-Asian patients with type 2 diabetes.MethodsWe systematically searched MEDLINE, EMBASE, Cochrane Library, and ISI Web of Science databases for articles published June 2017 and earlier in English. We identified randomized controlled trials (RCTs) of adults with type 2 diabetes that compared alogliptin with placebo as either monotherapy or add-on therapy. We divided subgroups by ethnicity, and compared the results of alogliptin use in Asian and non-Asian-dominant studies.ResultsA total of 15 RCTs with 4456 patients with type 2 diabetes were included in this study. Alogliptin lowered glycated hemoglobin (HbA1c) to a much greater extent in Asian-dominant studies [− 0.75% (95% CI − 0.84 to − 0.65)] than in non-Asian-dominant studies [− 0.61% (95% CI − 0.68 to − 0.54)] (P = 0.02). The risk ratio of achieving HbA1c goal was larger in Asian-dominant studies [2.88 (95% CI 2.15–3.87)] than in non-Asian-dominant studies [1.93 (95% CI 1.55–2.41)] (P = 0.03). The postprandial blood glucose-lowering efficacy was higher in Asian-dominant studies [− 2.42 mmol/l (95% CI − 2.99 to − 1.85)] than in non-Asian-dominant studies [− 0.60 mmol/l (95% CI − 1.60 to 0.40)] (P = 0.002), while the fasting blood glucose and body weight changes were similar between the two subgroups. The incidence of adverse events, including hypoglycemia, nasopharyngitis, upper respiratory tract infection, headache, and diarrhea, were comparable between the two groups.ConclusionsAlogliptin is more effective in improving glycemic levels in Asians than in other ethnic populations. Future studies are required to explore the potential mechanisms.

Impact of bromocriptine-QR therapy on cardiovascular outcomes in type 2 diabetes mellitus subjects on metformin

ABSTRACTObjectives: Type 2 diabetes mellitus (T2DM) is associated with a substantially increased risk of cardiovascular disease (CVD). Bromocriptine-QR (B-QR), a quick release sympatholytic dopamine D2 receptor agonist, is a FDA-approved therapy for T2DM which may provide CVD risk reduction. Metformin is considered to be an agent with a potential cardioprotective benefit. This large placebo controlled clinical study assessed the impact of B-QR addition to existing metformin therapy on CVD outcomes in T2DM subjects.Methods: 1791 subjects (1208 B-QR; 583 placebo) on metformin ± another anti-diabetes therapy at baseline derived from the Cycloset Safety Trial, a 12-month, randomized, multicenter, placebo-controlled, double-blind study in T2DM, were included in this study. The primary CVD endpoint evaluated was treatment impact on CVD event rate, prespecified as a composite of time to first myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina/congestive heart failure. Impact on glycemic control was evaluated as a secondary analysis.Results: The composite CVD end point occurred in 16/1208 B-QR treated (1.3%) and 18/583 placebo treated (3.1%) subjects resulting in a 55% CVD hazard risk reduction (intention-to-treat, Cox regression analysis; HR: 0.45 [0.23–0.88], p = 0.028). Kaplan-Meier curves demonstrated a significantly lower cumulative incidence rate of the CVD endpoint in the B-QR treatment group (Log-Rank p = 0.017). In subjects with poor glycemic control (HbA1c ≥ 7.5) at baseline, B-QR therapy relative to placebo resulted in a significant mean %HbA1c reduction of −0.59 at week 12 and −0.51 at week 52 respectively (p < 0.001 for both) and a 10 fold higher percent of subjects achieving HbA1c goal of ≤7% by week 52 (B-QR 30%, placebo 3%; p = 0.003).Conclusion: These findings suggest that in T2DM subjects on metformin, BQR therapy may represent an effective strategy for reducing CVD risk.Cycloset Safety Trial registration: ClinicalTrials.gov Identifier: NCT00377676.

The Importance of Postprandial Hyperglycemia Position Statement of the Danube Mco Experts

Abstract Both the prevalence and incidence of type 2 diabetes are increasing worldwide and over 60% of people with T2DM develop cardiovascular disease. There are many data supporting the view that glycaemic control plays a role in reducing cardiovascular complications. The relationship between hyperglycaemia and cardiovascular disease is complex with evidence suggesting that an acute increase of glycaemia, particularly after a meal, may have a direct detrimental effect on cardiovascular disease. Although control of fasting hyperglycaemia is necessary, it is usually insufficient to obtain optimal glycaemic control. A growing body of evidence suggests that reducing post meal plasma glucose excursions is as important, or perhaps more important for achieving HbA1c goals. New classes of therapies for managing post meal plasma glucose in people with diabetes (glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors) have shown significant benefits in reducing post meal plasma glucose excursions andlowering HbA1c. The individual properties of the various GLP‑1 receptor agonists might enable incretin-based treatment of type 2 diabetes mellitus to be tailored to the needs of each patient.

Empirically Establishing Blood Glucose Targets to Achieve HbA1c Goals

OBJECTIVETo determine the average fasting, postprandial, and bedtime self-monitored blood glucose (SMBG) concentrations associated with specified HbA1c levels using data from the A1c-Derived Average Glucose (ADAG) study.RESEARCH DESIGN AND METHODSThe ADAG study was a multicenter observational study that used continuous glucose monitoring and SMBG testing to determine the relationship between mean average glucose and HbA1c. We used the SMBG data from 470 of the ADAG study participants (237 with type 1 diabetes and 147 with type 2 diabetes) to determine the average fasting, premeal, 90-min postmeal, and bedtime blood glucose (BG) for predefined target HbA1c groups between 5.5 and 8.5% (37–69 mmol/mol). t Tests were used to compare mean BG values between type 1 and type 2 diabetes groups.RESULTSThe average fasting BG needed to achieve predefined HbA1c target levels of 5.5–6.49% (37–47 mmol/mol), 6.5–6.99% (48–52 mmol/mol), 7.0–7.49% (52–58 mmol/mol), 7.5–7.99% (58–64 mmol/mol), and 8.0–8.5% (64–69 mmol/mol) were 122 mg/dL with 95% CI 117–127, 142 mg/dL (135–150), 152 mg/dL (143–162), 167 mg/dL (157–177), and 178 mg/dL (164–192), respectively. Postmeal BG to achieve the HbA1c level of 6.5–6.99% (48–52 mmol/mol) and 7.0–7.49% (52–58 mmol/mol) were 139 mg/dL (134–144) and 152 mg/dL (147–157), respectively. Bedtime BG was 153 mg/dL (145–161) and 177 mg/dL (166–188), respectively.CONCLUSIONSWe have determined the average BG at premeal, postmeal, and bedtime to achieve a variety of HbA1c targets. These results, based on empirical data, will help patients and providers set realistic day-to-day SMBG targets to achieve individualized HbA1c goals.

Influence of the Type of Basal Insulin and Other Variables on Clinical Outcomes in Children with Newly Diagnosed Type 1 Diabetes

Background. Basal insulin detemir and glargine each have characteristics that may make them a superior choice in children and adolescents with type 1 diabetes, but there is a paucity of data on glycemic results in this population. Objective. Examination of variables associated with achievement of HbA1c goal in children and adolescents with newly diagnosed type 1 diabetes. Methods. The primary outcome, factors associated with achievement of HbA1c goal, was examined in a retrospective chart review. Variables, including type of basal insulin, were collected during the first year of diagnosis of patients in a pediatric diabetes clinic. Secondary outcomes included change in HbA1c, severe hypoglycemic events, and episodes of DKA. Results. 94 patients were included in the study. HbA1c at diagnosis was found to be a significant predictor of achievement of goal at 3 months (P = 0.002) and of change in HbA1c at 3 and 12 months (P < 0.001 for each). Severe hypoglycemia and episodes of DKA were uncommon. Conclusions. Choice of basal insulin was not found to be a predictor of achieving HbA1c goal or of change in HbA1c over the course of the first year of diagnosis with type 1 diabetes.

Abstract P047: Improved Clinical Outcomes Associated with Dual-Goal (HbA1c and LDL-C) Achievement in Newly Diagnosed Type 2 Diabetes Mellitus

Background: Compared with studies on achieving a single goal of either glycated hemoglobin (HbA1c) or low-density lipoprotein cholesterol (LDL-C) in type 2 diabetes mellitus (T2DM), the clinical benefits of dual-goal achievement (LDL-C&lt;100 mg/dl and HbA1c&lt;7%) are not well documented. This study investigated factors and clinical benefits associated with dual-goal achievement in newly diagnosed T2DM patients. Methods: Newly diagnosed adult T2DM patients with ≥2 measures of LDL-C and HbA1c were identified in the Veterans Integrated Services Network 16 data warehouse (01/2004-06/2010). A logistic regression model was used to identify factors associated with dual-goal achievement during 7-12 months following the index date (first HbA1c recorded within three months of the first T2DM diagnosis). Factors included demographics and 0-6 month dual-goal achievement, as well as diabetes-related comorbidities, medications, surgeries, and healthcare utilization, all measured during the 1-year period surrounding the index date. Multivariate Cox proportional hazards models were used to assess the association between time-varying goal achievement status and post-index date clinical outcomes, including microvascular complications (retinopathy, nephropathy, and neuropathy), cardiovascular-related complications (cardiovascular death, stroke, or myocardial infarction) and acute coronary syndromes (ACS). Results: A total of 16,829 T2DM patients were included in the study. Factors associated with an increased likelihood of dual-goal achievement include older age, higher Charlson Comorbidity Index (CCI), prior dual-goal achievement, diagnosis of ketoacidosis or hypersmolarity, and lipid-lowering drug use. Conversely, patients with prior diagnoses of retinopathy, neuropathy, and congestive heart failure, as well as prior insulin use were less likely to achieve both goals. Compared with failure to achieve either goal, achieving only LDL-C goal was associated with a lower risk of cardiovascular-related complications (HR:0.76; 95% CI:0.71-0.81) and ACS (HR:0.76; 95% CI:0.67-0.86), while achieving only HbA1C goal was associated with a lower risk of microvascular complications (HR:0.73; 95% CI:0.71-0.74), cardiovascular-related complications (HR:0.80; 95% CI:0.74-0.87) and ACS (HR:0.66; 95% CI:0.60-0.72). Dual-goal achievement was associated with additional reduction in risk of microvascular complications (HR: 0.69; 95% CI: 0.63-0.76) vs. only LDL-C goal achievement, but had similar risk to achieving HbA1c goal alone. Conclusions: Older age, higher CCI, prior dual-goal achievement, and lipid-lowering drug use were associated with a greater likelihood of dual-goal achievement. Dual-goal achievement in newly diagnosed T2DM patients is associated with decreased risks of microvascular complications than those with only LDL-C goal achievement.