Diabetes In Real-world Clinical Practice Research Articles

Evaluation of hybrid closed-loop insulin delivery system in type 1 diabetes in real-world clinical practice: One-year observational study.

In 2016, the Food and Drug Administration approved the first hybrid closed-loop (HCL) insulin delivery system for adults with type 1 diabetes (T1D). There is limited information on the impact of using HCL systems on patient-reported outcomes (PROs) in patients with T1D in real-world clinical practice. In this independent study, we evaluated glycemic parameters and PROs over one year of continuous use of Medtronic's 670G HCL in real-world clinical practice. To assess the effects of hybrid closed loop system on glycemic control and quality of life in adults with T1D. We evaluated 71 patients with T1D (mean age: 45.5 ± 12.1 years; 59% females; body weight: 83.8 ± 18.7 kg, body mass index: 28.7 ± 5.6 kg/m2, A1C: 7.6% ± 0.8%) who were treated with HCL at Joslin Clinic from 2017 to 2019. We measured A1C and percent of glucose time-in-range (%TIR) at baseline and 12 months. We measured percent time in auto mode (%TiAM) for the last two weeks preceding the final visit and assessed PROs through several validated quality-of-life surveys related to general health and diabetes management. At 12 mo, A1C decreased by 0.3% ± 0.1% (P = 0.001) and %TIR increased by 8.1% ± 2.5% (P = 0.002). The average %TiAM was only 64.3% ± 32.8% and was not associated with A1C, %TIR or PROs. PROs, provided at baseline and at the end of the study, showed that the physical functioning submodule of 36Item Short-Form Health Survey increased significantly by 22.9% (P < 0.001). Hypoglycemia fear survey/worry scale decreased significantly by 24.9% (P < 0.000); Problem Areas In Diabetes reduced significantly by -17.2% (P = 0.002). The emotional burden submodules of dietary diversity score reduced significantly by -44.7% (P = 0.001). Furthermore, analysis of Clarke questionnaire showed no increase in awareness of hypoglycemic episodes. WHO-5 showed no improvements in subject's wellbeing among participants after starting the 670G HCL system. Finally, analysis of Pittsburgh Sleep Quality Index showed no difference in sleep quality, sleep latency, or duration of sleep from baseline to 12 mo. The use of HCL in real-world clinical practice for one year was associated with significant improvements in A1C, %TIR, physical functioning, hypoglycemia fear, emotional distress, and emotional burden related to diabetes management. However, these changes were not associated with time in auto mode.

Fast-Acting Insulin Aspart in Patients with Type1 Diabetes in Real-World Clinical Practice: A Noninterventional, Retrospective Chart and Database Study.

This study utilized continuous glucose monitoring data to analyze the effects of switching to treatment with fast-acting insulin aspart (faster aspart) in adults with type1 diabetes (T1D) in clinical practice. A noninterventional database review was conducted in Sweden among adults with T1D using multiple daily injection (MDI) regimens who had switched to treatment with faster aspart as part of basal-bolus treatment. Glycemic data were retrospectively collected during the 26weeks before switching (baseline) and up to 32weeks after switching (follow-up) to assess changes in time in glycemic range (TIR; 70-180mg/dL), mean sensor glucose, glycated hemoglobin (HbA1c) levels, coefficient of variation, time in hyperglycemia (level1, > 180 to ≤ 250mg/dL; level2, > 250mg/dL), and time in hypoglycemia (level1, ≥ 54 to < 70mg/dL; level2, < 54mg/dL) (ClinicalTrials.gov Identifier NCT03895515). Overall, 178 participants were included in the study cohort. The analysis population included 82 individuals (mean age 48.5years) with adequate glucose sensor data. From baseline to follow-up, statistically significant improvements were reported for TIR (mean increase 3.3%-points [approximately 48min/day]; p = 0.006) with clinically relevant improvement (≥ 5%) in 43% of participants. Statistically significant improvements from baseline were observed for mean sensor glucose levels, HbA1c levels, and time in hyperglycemia (levels1 and 2), with no statistically significant changes in time spent in hypoglycemia. Switching to faster aspart was associated with improvements in glycemic control without increasing hypoglycemia in adults with T1D using MDI in this real-world setting.

Long-term effect of intensive lifestyle intervention on cardiometabolic risk factors and microvascular complications in patients with diabetes in real-world clinical practice: a 10-year longitudinal study

IntroductionIntensive lifestyle intervention (ILI) has significantly reduced incidence of diabetes and improved many cardiovascular disease risk factors. We evaluated long-term effects of ILI on cardiometabolic risk factors, and microvascular and...

IDF2022-0438 The effect of insulin degludec in people with type 2 diabetes in real-world clinical practice in China

IDF2022-0438 The effect of insulin degludec in people with type 2 diabetes in real-world clinical practice in China

Влияние иДПП-4 эвоглиптина на показатели вариабельности уровня глюкозы и времени в целевом диапазоне у пациентов с сахарным диабетом 2 типа в условиях реальной клинической практики по сравнению с препаратами производных сульфонилмочевины (собственный опыт)

An early diagnosis of diabetes to prescribe effective and safe glucose-lowering therapy is important for organizing diabetes care. To analyze the efficacy and safety of modern glucose-lowering drugs, continuous glucose monitoring, or flash glucose monitoring, allowing a more detailed assessment of glycemic fluctuations within a specified period of time is actively introduced into real-world clinical practice. Over the past two decades, significant progress has been made in providing specialized medical care to patients with type 2 diabetes (T2D) due to the introduction of novel classes of glucose-lowering drugs into clinical practice. The mechanism of action of drugs belonging to dipeptidyl peptidase 4 (DPP-4) inhibitors is based on insulin-dependent modulation of insulin and glucagon production. Their use is characterized by a good safety profile, including an extremely low risk of hypoglycemia in T2D. The authors describe their experience with the DPP-4 inhibitor evogliptin in these patients. A strong tendency to a reduction in the total number of hypoglycemia recorded by flash monitoring, overall time below range (&lt;3.9 mmol/l), and time below range (&lt;3.0 mmol/l). The emergence on the Russian market of modern, available, locally produced DPP-4 inhibitors may significantly improve the safety of T2D therapy. KEYWORDS: glucose-lowering drug, continuous glucose monitoring, diabetes, diabetes care, hypoglycemia, evogliptin. FOR CITATION: Kalashnikova M.F., Teplov E.V., Likhodey N.V., Maloletkina E.S., Vavil'chenkova K.S., Glinkina I.V. Effect of dipeptidyl peptidase 4 inhibitor evogliptin on glycemic variability and time in range in patients with type 2 diabetes in real-world clinical practice compared with sulfonylureas (authors experience). Russian Medical Inquiry. 2023;7(9):598–605 (in Russ.). DOI: 10.32364/2587-6821-2023-7-9-7.

Effect of Dapagliflozin in Combination with Lobeglitazone and Metformin in Korean Patients with Type 2 Diabetes in Real-World Clinical Practice.

PurposeThis study aimed to evaluate the efficacy and tolerability of dapagliflozin as an add-on or a switch therapy to lobeglitazone plus metformin (MFM) in Korean patients with inadequately controlled type 2 diabetes mellitus (T2DM) in real-world clinical practice.Materials and MethodsThe study included 109 patients who started dapagliflozin as add-on or switch therapy to lobeglitazone plus MFM. The primary outcome was a change in glycated hemoglobin (HbA1c) level from baseline after 12 months of treatment. Secondary outcomes included changes in fasting plasma glucose (FPG), lipid profiles, body weight, visceral fat area (VFA), and blood pressure after 12 months of treatment.ResultsThe baseline HbA1c was 8.3±1.3% (8.7±1.5% in the add-on group and 8.1±1.0% in the switch group). After 12 months, mean HbA1c decreased (-0.91%) in all patients (p<0.05) (-1.39% in the add-on group and -0.63% in the switch group). Significant reductions in FPG were also observed in both the add-on and switch groups (-54.37 mg/dL and -24.68 mg/dL, respectively). Overall, there was a significant improvement in serum triglyceride (-24.74 mg/dL), low density lipoprotein cholesterol (-7.92 mg/dL), body weight (-2.98 kg), VFA (-9.00 cm2), and systolic blood pressure (-8.67 mm Hg). Approximately 35.8% of patients achieved HbA1c <7.0% after 12 months.ConclusionDapagliflozin, as an add-on or a switch therapy to lobeglitazone plus MFM, can be a suitable alternative for Korean patients with inadequately controlled T2DM. The combination therapy resulted in significant reductions in HbA1c levels, body weight, and blood pressure.

Mortality and morbidity following postoperative use of short‐term, low‐dose quetiapine vs risperidone in patients with diabetes: Analysis using a national inpatient database

Short-term, low-dose quetiapine is used to treat postoperative delirium and insomnia. Quetiapine is contraindicated for patients with diabetes in Japan because there have been several case reports of diabetic ketoacidosis (DKA) in patients receiving long-term, high-dose quetiapine. However, because safety of short-term, low-dose quetiapine remains controversial, it is prescribed for patients with diabetes in real-world clinical practice. The present study aimed to compare in-hospital mortality and morbidity between short-term, low-dose quetiapine and risperidone in postoperative patients with diabetes. We used a national inpatient database in Japan to perform a retrospective cohort study. We identified hospitalized patients with diabetes who underwent scheduled elective surgery and received oral quetiapine 200 mg/d or less or oral risperidone 4 mg/d or less within 7 days of surgery between July 2010 and March 2018. We performed one-to-one propensity score-matched analyses to compare outcomes between patients with quetiapine and risperidone. The primary outcome was in-hospital mortality. The secondary outcome was infectious complications (pneumonia, urinary tract infection, surgical site infection, and sepsis). Propensity score matching created 665 pairs of patients who received quetiapine or risperidone. The primary outcome was observed in 19 (2.9%) of the quetiapine group and 11 (1.7%) of the risperidone group (relative risk, 1.27; 95% confidence interval, 0.97-1.68; P = .14). The secondary outcome did not differ significantly between the groups. In terms of mortality and infectious outcomes, safety of quetiapine and risperidone may be comparable.

976-P: Evaluation of Hybrid Closed-Loop Insulin Delivery System for Patients with Type 1 Diabetes in Real-World Clinical Practice: A One-Year Qualitative Observational Study

The MiniMed™ 670G (670G) is the first FDA approved hybrid closed-loop insulin delivery system for patients with type 1 diabetes (T1D). In Auto Mode, the integrated continuous glucose monitor (CGM) captures glucose values every five minutes and, via a built-in algorithm, the 670G system automatically adjusts basal insulin delivery targeting a glucose value of 120 mg/dL. Impact of the use of 670G system on patient reported outcomes in people with T1D are limited. Data over one year of use in real world-clinical practice were collected. We evaluated 53 patients with T1D (mean age 46.8±11.8 years, 62% females, body weight 82.5±17.6 kg, BMI 28.7±5.5, HbA1c 7.6±0.8%) who started 670G at the Joslin Clinic between December 2017 and December 2019. Data were collected at baseline and after 12 months. We assessed SROs by administering surveys: 36 Item Short-Form Health Survey (SF 36), Pittsburgh Sleep Quality Index (PSQI), and hypoglycemia fear survey/worry scale (HFS_W). We also measured HbA1c, % time-in-range at baseline and 12 months, and % time in auto mode (TiAM) for the two weeks preceding the final study visit. At 12 months, A1C decreased by 0.3±0.1% from baseline (p&amp;lt;0.01) and % time-in-range increased by 7.9±3.1% from baseline (p=0.015) with no correlation between either of them and %TiAM (p=0.3, p=0.2 respectively). Physical functioning increased by 47.5% from baseline (p&amp;lt;0.001), and HFS_W improved significantly by -16.0% from baseline (p=0.017). At 12 months, average %TiAM was 60.4±33.7% and was not associated with clinical outcomes or SROs. We conclude that use of 670G for a year in real-world clinical practice was associated with significant improvement in A1C, % time-in-range, physical functioning and hypoglycemia fear. Neither of these improvements at 12 months was related to %TiAM. Disclosure A.H. Eldib: None. S. Tomah: Stock/Shareholder; Self; Amarin Corporation. S.E. Dhaver: None. H. Gardner: None. M. Tasabehji: None. M. Albadri: None. A. Atakov-Castillo: None. E. Toschi: None. O. Hamdy: Consultant; Self; Abbott, AstraZeneca, Merck &amp; Co., Inc., Sanofi-Aventis. Research Support; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Healthimation, LLC.

238-OR: Long-Term Effects of Intensive Lifestyle Intervention on Cardiovascular Risk Factors in Patients with Diabetes in Real-World Clinical Practice: A 10-Year Longitudinal Study

We previously reported that maintenance of significant weight loss for up to 5 years was attainable in real-world clinical practice among patients with diabetes and obesity and had a positive impact on cardiovascular risk factors. This was predicted by the ability to achieve ≥7% weight loss at 1 year through intensive lifestyle intervention (ILI). In this longitudinal study of the same cohort, we report the 10-year follow-up results. The study included 129 patients with diabetes and obesity enrolled in a 12-week ILI program designed for real-world clinical practice. At 1 year, we divided participants into group A, who maintained &amp;lt;7% weight loss (61 patients, 47.3%), and group B, who maintained ≥7% weight loss (68 patients, 52.7%). We prospectively followed them for 10 years. The total cohort lost on average 10.8±4.6 Kg (-9.7%) at 12 weeks and maintained an average weight loss of 7.7±10 Kg (-6.9%) at 10 years. Group A maintained 4.3±9.5 Kg (-4.3%) and group B maintained 10.8±9.3 Kg (-9.3%) of weight loss at 10 years (P&amp;lt;0.001). In group A, A1C decreased from 7.5±1.3% to 6.7±0.9% at 12 weeks but rebounded to 7.7±1.4% at one year and 8.0±1.9% at 10 years. In group B, A1C decreased from 7.4±1.2% to 6.4±0.9% at 12 weeks and rose to 6.8±1.2% at one year and 7.3±1.5% at 10 years (P&amp;lt;0.05 between groups). Despite weight regain, group A maintained significant improvements in LDL and HDL cholesterol, had no change in BP, but significant worsening of serum triglycerides (TG) at 10 years. Group B maintained similar improvements in lipid profile, had a non-significant increase in serum TG at 10 years, but lower BP for the initial 18 months. In conclusion, significant weight reduction in patients with diabetes can be maintained for up to 10 years in real-world clinical practice. A1C and TG worsened with weight regain, while other lipid improvements were maintained. Sustained weight loss is associated with significantly better A1C at 10 years. Disclosure H. Zhang: None. S. Tomah: Stock/Shareholder; Self; Amarin Corporation. A. Mottalib: None. S. Ashrafzadeh: None. O. Hamdy: Advisory Panel; Self; AstraZeneca, Sanofi-Aventis. Consultant; Self; Abbott, Merck &amp; Co., Inc. Research Support; Self; National Dairy Council. Stock/Shareholder; Self; Healthimation, LLC.

Use of Linagliptin for the Management of Medicine Department Inpatients with Type 2 Diabetes in Real-World Clinical Practice (Lina-Real-World Study).

The use of noninsulin antihyperglycaemic drugs in the hospital setting has not yet been fully described. This observational study compared the efficacy and safety of the standard basal-bolus insulin regimen versus a dipeptidyl peptidase-4 inhibitor (linagliptin) plus basal insulin in medicine department inpatients in real-world clinical practice. We retrospectively enrolled non-critically ill patients with type 2 diabetes with mild to moderate hyperglycaemia and no injectable treatments at home who were treated with a hospital antihyperglycaemic regimen (basal-bolus insulin, or linagliptin-basal insulin) between January 2016 and December 2017. Propensity score was used to match patients in both treatment groups and a comparative analysis was conducted to test the significance of differences between groups. After matched-pair analysis, 227 patients were included per group. No differences were shown between basal-bolus versus linagliptin-basal regimens for the mean daily blood glucose concentration after admission (standardized difference = 0.011), number of blood glucose readings between 100–140 mg/dL (standardized difference = 0.017) and >200 mg/dL (standardized difference = 0.021), or treatment failures (standardized difference = 0.011). Patients on basal-bolus insulin received higher total insulin doses and a higher daily number of injections (standardized differences = 0.298 and 0.301, respectively). Basal and supplemental rapid-acting insulin doses were similar (standardized differences = 0.003 and 0.012, respectively). There were no differences in hospital stay length (standardized difference = 0.003), hypoglycaemic events (standardized difference = 0.018), or hospital complications (standardized difference = 0.010) between groups. This study shows that in real-world clinical practice, the linagliptin-basal insulin regimen was as effective and safe as the standard basal-bolus regimen in non-critical patients with type 2 diabetes with mild to moderate hyperglycaemia treated at home without injectable therapies.

Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study

ABSTRACTBackground: Data regarding the efficacy and safety of sodium–glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data).Research design and methods: All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM.Results: At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%).Conclusions: Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.

Long-term effect of intensive lifestyle intervention on cardiovascular risk factors in patients with diabetes in real-world clinical practice: a 5-year longitudinal study

目的 我们评估了在临床中持续减重与增重对心血管危险因素的长期影响。 方法 我们在Why WAIT计划（为期12周的强化生活方式干预）中评估了129例肥胖的糖尿病患者，1年后我们将入组人群分为A组（减重<7%）（47.3%）和B组（减重≥7%）（52.7%），之后我们进行了5年的跟踪随访。 结果 整个入组人群在12周时减重23.8磅（-9.7%），5年后减重16.2磅（-6.4%）（P<0.001），其中A组减重8.4磅（-3.5%）、B组减重23.1磅（-9.0%）。A组糖化血红蛋白在12周时由（7.5±1.3）%下降到（6.7±0.9）%，1年后上升到（7.7±1.4）%，5年后上升到（8.0±1.9）%。B组糖化血红蛋白在12周时由（7.4±1.2）%下降到（6.4±0.9）%，1年上升至（6.8±1.2）%，5年后上升为（7.3±1.5）%。尽管体重有所反弹，A组的低密度脂蛋白胆固醇和高密度脂蛋白胆固醇仍是有所改善的，但是血清甘油三酯升高，血压无明显变化。5年内B组的血脂谱仍有所改善，18个月内血压显著降低。 结论 糖尿病患者减重维持5年，预计1年时体重可以下降7%以上。糖化血红蛋白和甘油三酯随着体重的恢复而升高，而其他的血脂谱则保持不变。持续的体重下降与糖化血红蛋白显著降低达5年和血压降低达18个月相关。

Self-reported Hypoglycaemic Events in 2 430 Patients with Insulin-treated Diabetes in the German Sub-population of the HAT Study.

Data concerning true hypoglycaemic incidence in insulin-treated patients with diabetes in real-world clinical practice are lacking in Germany. The aim of this analysis was to determine the incidence of hypoglycaemia experienced by the German cohort of patients enrolled in the global Hypoglycaemia Assessment Tool (HAT) study. This was a non-interventional, 6-month retrospective and 4-week prospective study using self-assessment questionnaires and patient diaries assessing patients aged ≥18 years in Germany, with type 1 diabetes (T1D) (n=811) or type 2 diabetes (T2D) (n=1 619) treated with insulin for >12 months. The primary endpoint was the percentage of patients experiencing ≥1 hypoglycaemic event during the prospective observational period (4 weeks after baseline). Predictive and continuous factors (such as age, gender, duration of insulin use and HbA1c) contributing to hypoglycaemia risk were explored.During the prospective period, at least one hypoglycaemic event was reported by 81.3% of patients with T1D and 39.7% of patients with T2D, indicating that hypoglycaemia is a common acute complication among patients with insulin-treated diabetes. Severe hypoglycaemia was reported by 9.1% of patients with T1D and 5.4% of patients with T2D. Higher rates of any and severe hypoglycaemia were reported prospectively than retrospectively, regardless of diabetes type, indicating that patients retrospectively under-report hypoglycaemia. Prospective rates (events per patient-year) of any, nocturnal and severe hypoglycaemia were 80.3, 9.9 and 3.0 for T1D and 15.6, 2.4 and 1.1 for T2D, respectively. Given the potential for recall bias in retrospective reporting, this prospective assessment of hypoglycaemia appears more reliable than retrospective assessment. Trial number: NCT01696266.

Long-term effect of intensive lifestyle intervention on cardiovascular risk factors in patients with diabetes in real-world clinical practice: a 5-year longitudinal study

ObjectiveWe evaluated long-term impact of sustained weight loss versus weight regain on cardiovascular risk factors in real-world clinical practice.MethodsWe evaluated 129 obese patients with diabetes enrolled in Weight Achievement and...

Insulin intensification with basal plus mealtime insulin or mid-mixture premixed insulin in type 2 diabetes in real-world clinical practice

Insulin intensification with basal plus mealtime insulin or mid-mixture premixed insulin in type 2 diabetes in real-world clinical practice

Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice

ABSTRACTObjective: To evaluate the efficacy and safety of ipragliflozin in real-world clinical practice in Japanese patients with type 2 diabetes.Research design and methods: We conducted interim analyses at 3 months of a 3-year prospective study of patients who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015, and whose data were locked by 16 January 2016.Main outcome measures: Changes in glycemic control, blood pressure, and laboratory variables from baseline, and incidence of adverse drug reactions (ADRs).Results: Of 11,412 patients initially registered, efficacy and safety data were available for 3481 (30.5%) and 4360 (38.2%) patients, respectively. Hemoglobin A1c and fasting plasma glucose decreased by 0.67% and 28.8 mg/dL, respectively, at 3 months/last assessment (both P < .001) from baseline (8.00% and 166.4 mg/dL, respectively). Blood pressure and lipid levels also improved significantly. There were 258 ADRs in 194 patients. The ADRs included ‘renal and urinary disorders’ (system organ class) in 110 patients (2.5%).Conclusions: These 3-month interim results indicate that ipragliflozin improved glycemic control, lipids, and blood pressure with low rates of ADRs in Japanese patients with type 2 diabetes in real-world clinical practice. The results were consistent with those of placebo-controlled, randomized clinical trials.Clinicaltrials.gov identifier: NCT02479399

Glycemic Control With Insulin Glargine Plus Insulin Glulisine Versus Premixed Insulin Analogues in Real-World Practices: A Cost-Effectiveness Study With a Randomized Pragmatic Trial Design

Background Cost can be an important consideration, along with safety and efficacy, in deciding the most appropriate treatment for patients with type 2 diabetes. Both basal-bolus and premixed insulin analogue regimens are widely used in clinical practice; however, limited information is available regarding cost-effectiveness. Objective The goal of this study was to compare glycemic control, cost-effectiveness, and quality of life effects of insulin glargine plus insulin glulisine (glargine/glulisine) versus premixed insulin analogues in real-world clinical practice. Methods Adults with type 2 diabetes (glycosylated hemoglobin [HbA 1c] ≥7.0%) at 3 US endocrinology centers were randomly assigned to receive either glargine/glulisine or premixed insulin analogues and continued treatment following the centers' usual practice. HbA 1c, weight, insulin dose, concomitant oral antidiabetic drug (OAD) usage, and hypoglycemia were evaluated at baseline and 3, 6, and 9 months. Medication costs, including costs for all insulin or OAD regimens, were estimated using published wholesale acquisition costs. Results A total of 197 patients were randomized to receive glargine/glulisine therapy (n = 106) or premixed analogue therapy (n = 91). Overall, the mean age was 56 years, the mean duration of diabetes was 13 years, with a mean HbA 1c of 9.25% and mean BMI of 35.8 kg/m 2 at baseline. Patients randomized to receive glargine/glulisine had a greater mean HbA 1c reduction from baseline (–2.3%) than patients receiving a premixed analogue regimen (–1.7%). Adjusted mean follow-up HbA 1c was 6.9% versus 7.5%, respectively (difference, –0.59%; P < 0.01). The glargine/glulisine group also used a lower mean number of OADs (0.86 vs 1.14; difference, –0.28; P = 0.04) but had a higher weight (240 vs 235 lb; difference, 4.55 lb; P = 0.03) than the premixed analogue group at follow-up. There were no significant differences in daily insulin dose and rates of hypoglycemia. Overall medication costs per 1.0% reduction in HbA 1c were $841 with glargine/glulisine and $1308 with premixed analogues. Conclusions Overall, treatment with glargine/glulisine provided greater improvement in glycemic control and may represent a more cost-effective treatment option than premixed regimens for patients with type 2 diabetes in real-world clinical practice. However, due to the pragmatic trial design, the study concluded before follow-up assessments were available for all randomized patients.

AS-256: Triple versus Dual Antiplatelet Therapy in Chronic Stable Angina Patients with Diabetes Undergoing Elective Percutaneous Coronary Intervention with Drug-Eluting Stents

Adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) is known to reduce restenosis and is associated with favorable clinical outcomes in diabetes. However, there is limited data related to the use of triple antiplatelet therapy in chronic stable angina patients with diabetes in real-world clinical practice.