Patients Achieving HbA1c Targets Research Articles

Enhancing Diabetes Management Education in Community Health Centers: Empowering Patients and Improving Health Outcomes

Background: Diabetes poses significant public health challenges globally, with South Africa experiencing high prevalence rates, particularly in underserved regions. The lack of tailored diabetes management programs in community health centers (CHCs) exacerbates poor health outcomes and increases healthcare costs. Methods and Materials: This project aimed to enhance diabetes management education at Pholela Community Health Centre in Durban, South Africa, through comprehensive educational interventions and healthcare provider training. Culturally sensitive educational materials were developed and delivered in multiple languages, targeting patient self-management and healthcare provider competence. Results : The intervention led to a 20% increase in the proportion of diabetic patients achieving target HbA1c levels within one year. Healthcare providers showed improved proficiency in delivering culturally sensitive, evidence-based diabetes care. Patient education workshops and peer support groups significantly improved patient knowledge and self-management practices. Conclusion: The project successfully addressed critical gaps in diabetes education and care at Pholela CHC, resulting in improved patient outcomes and enhanced healthcare practices. Continued community engagement and resource allocation are essential for sustaining these improvements and reducing the disease burden in underserved populations.

Retrospective Study on the Impact of COVID-19 Lockdown on Patients with Type 2 Diabetes in Northern Taiwan.

During the COVID-19 pandemic, the national lockdown had a significant impact on healthcare systems and diabetes management. The results of relevant studies were inconsistent. The aim of the study was to investigate the impact of lockdown on glycemic control among patients with type 2 diabetes mellitus(T2D) in Taiwan. This was a retrospective study conducted in a single regional hospital in Northern Taiwan. The clinic characteristics of the patients were summarized. Anthropometric and biochemical data before and after the lockdown were collected and analyzed. Stepwise multiple regression analysis was performed to identify the independent determinants of variables, including baseline characteristics and laboratory parameters, for the changes in glycated hemoglobin(HbA1c). A total of 943 (females 48.5%) patients with T2D were enrolled. The mean age of the patients was 60.6±12.3years, with a mean HbA1c of 7.0±1.0%, a mean diabetes duration of 7.3±4.6years, and a mean body mass index(BMI) of 26.5±4.5kg/m2. The overall means of HbA1c and fasting blood glucose were significantly improved after the lockdown compared to before (7.0±1.0 vs 6.8±0.9, p<0.001 and 132.2±33.3 vs 124.4±30.0, p<0.001, respectively). The proportion of patients achieving HbA1c target (≤7%) was higher after the lockdown compared to before (61.5% vs 68.9%, p<0.001). Stepwise multiple regression analysis revealed that baseline HbA1c before the lockdown was a positive contributor to the change in HbA1c after the lockdown, whereas BMI and co-morbidity with dyslipidemia were negative contributors (standardized coefficient +0.16, p<0.001; -0.07, p=0.025; -0.12, p=0.001, respectively). Our study highlights the benefits of lockdown measures on diabetic control in Northern Taiwan as a single-center experience with the improvement of HbA1c and fasting blood glucose. Understanding these consequences of national lockdown can help healthcare providers to improve diabetes care during the pandemic.

328-OR: Evaluation of Mobile Health Technology–Based Diabetes Education System for Self-Management of Patients with Type 2 Diabetes Mellitus

Ongoing research has established that mobile health applications (apps) are feasible tools for improving self-management of diabetes and to maintain glycemic control. This single-arm, multi-center, observational study evaluated the effectiveness of an app-based diabetes education program in improving HbA1c among patients with type 2 diabetes mellitus (T2DM) treated with premixed insulin for 12 weeks. A total of 9426 patients were included. Primary endpoint was the change in HbA1c from baseline to week 12. Secondary endpoints included the association of HbA1c reduction with number of diabetes education courses completed and learning mode, and the association of SMBG frequency with diabetes education courses. According to the number of diabetes education courses completed, the patients were divided into 3 groups: 0-4 courses, 5-29 courses, and ≥30 courses. After 12 weeks of engagement in app, there was a decrease in HbA1c levels (9.84 ± 1.47 % vs. 7.36 ± 1.15 %) with 36% of patients achieving HbA1c target at week 12. The HbA1c control rate was the highest among patients completing ≥30 courses (49%; mean change: -2.9%) , followed by those who completed 5-29 courses (38%; -2.7%) and 0-4 courses (35%; -2.4%) (P&amp;lt;0.0001) . Besides, the frequency of SMBG testing increased with the ascending number of courses completed (≥30 courses: 7.4 times/week; 5-29 courses: 3.5 times/week; 0-4 courses: 1.2 times/week; P&amp;lt;0.0001) . HbA1c reduction (-2.7% vs. -2.4%; P&amp;lt;0.0001) and the proportion of patients with HbA1c &amp;lt;7% (42% vs. 35%; P&amp;lt;0.0001) were significantly lower in patients who preferred audio-visual learning over visual learning for diabetes course engagement. To summarize, participants who completed more diabetes education courses had better HbA1c reduction over 12 weeks and better self-management of blood glucose with the app. Disclosure C.Si: None. J.Lu: None. Y.Bao: None. J.Zhou: n/a. W.Jia: None.

Economic analysis of glucagon like peptide-1 receptor agonists from the Saudi Arabia payer perspective

ObjectivesTo perform a cost of control analysis of glucagon like peptide-1 receptor agonists (GLP1RA) in Saudi Arabia (SA) and determine the economic impact of adopting GLP1RAs. MethodsA budget impact model that captures the cost of control model was constructed to simulate hypothetical patient on six treatment options: a current mix of 60% liraglutide and 40% dulaglutide, semaglutide, liraglutide, dulaglutide, exenatide, and lixisenatide. We estimated the relative amounts of SAR spend to achieve HbA1c targets (≤6.5% or < 7.0%). For each treatment option, annual treatment cost, proportion of patients achieving HbA1c targets, and cost to treat major adverse cardiovascular events (MACE) were aggregated to estimate the cost of control per patient per year (CCPPPY) over 5-year horizon (2021–2025). Probabilistic sensitivity analysis (PSA) was performed as a confirmatory analysis. ResultsThe CCPPPY to achieve HbA1c ≤ 6.5%/<7.0% using current mix, semaglutide, liraglutide, dulaglutide, exenatide, and lixisenatide were SAR 17,097/SAR 14,113, SAR 12,889/SAR 11,123, SAR 15,594/SAR 12,892, SAR 19,184/SAR 15,940, SAR 580,211/SAR 380,936, and SAR 246,570/SAR 143,759, respectively. The relative amounts of SAR spend to achieve HbA1c ≤ 6.5%/<7.0% relative to 1 SAR on semaglutide in case of adopting current mix, liraglutide, dulaglutide, exenatide, and lixisenatide were SAR 1.42/SAR 1.18, SAR 1.30/SAR 1.07, SAR 1.60/SAR 1.33, SAR 48.33/SAR 31.73, and SAR 20.54/SAR 11.97, respectively. These results were confirmed in the PSA. ConclusionsSemaglutide 1 mg once weekly was the most economically favorable GLP1RA; associated with the least CCPPPY, and amount of SAR spent to achieve HbA1c of ≤6.50%/<7.00% versus all other GLP1RAs.

Real-world Retrospective Assessment of Initiation and Effectiveness of Dual Combination Therapy with Metformin and Teneligliptin in Drug Naïve Indian Type 2 Diabetes Mellitus Patients (INITIATE)

Introduction: Diabetes Mellitus (DM) has become the leading health concern worldwide over the last few decades. But despite advances in both understanding of the pathophysiology of Type 2 Diabetes Mellitus (T2DM), and the development of new treatment strategies, current management of patients with T2DM remains suboptimal. Initial monotherapy is frequently inadequate in patients with high baseline Glycated Haemoglobin (HbA1c). Thus, initial combination therapy has emerged as an alternative approach. Aim: To assess INItiation and effecTiveness of dual combInation therapy with metformin And Teneligliptin in drug naïvE T2DM patients (INITIATE). Materials and Methods: In this retrospective, multicentre study, newly diagnosed drug naïve T2DM patients failed with diet and exercise prior to screening and initiated with dual therapy of metformin and teneligliptin were enrolled. Data of all the patients prescribed with any therapeutic dose of metformin (250 mg, 500 mg, 750 mg, 1000 mg, 1500 mg, 2000 mg) and teneligliptin (20 mg, 40 mg) was considered. The data was analysed to assess change in glycaemic parameters from baseline to 12 weeks. Paired t-test was applied for statistical results. Results: Data of 7857 patients were analysed. The mean change of Fasting Plasma Glucose (FPG) from baseline {202.29±52.2 mg/dL (11.23±2.89 mmol/L)} to 12 weeks {142.57±34.5 mg/dL (7.91±1.91 mmol/L)} was -59.72±17.7 mg/dL (-3.31±0.98 mmol/L) (p-value &lt;0.0001). The absolute change in mean Postprandial Plasma Glucose (PPG) from baseline {(286.26±80.43 mg/dL (15.89±4.46 mmol/L)} to 12 weeks {(198.30±42.24 mg/dL (11±2.34 mmol/L)} was -87.96±38.19 mg/dL (-4.88±2.12 mmol/L) (p-value &lt;0.0001). Mean HbA1c level was 8.11%±1% (65±10.9 mmol/mol) at baseline and decreased significantly to 7.15%±0.94% (55±10.3 mmol/mol) (p-value &lt;0.0001) with a mean change of -0.96±0.06 (-10.5±0.7 mmol/mol) at 12 weeks. Total 42.83% (n=3365) patients achieved target HbA1c (&lt;7%) at 12 weeks. Conclusion: Initiation of dual therapy with metformin and teneligliptin in drug naïve Indian T2DM patients significantly improved glycaemic control.

Composite cardiovascular risk and BMI affected comparative profiles of BIAsp 30\u2009+\u2009metformin vs BIAsp 30 monotherapy: a MERIT post-hoc analysis

We assessed whether comparative efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) plus metformin versus BIAsp 30 monotherapy differed for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetic drugs with different cardiovascular risk scores and different body mass indexes (BMI) by performing a post hoc analysis of the randomized controlled MERIT study. In the MERIT study, eligible patients were randomized 1:1 to receive BIAsp 30 plus metformin or BIAsp 30 for 16 weeks. Patients in the 2 treatment groups were classified into “low” and “high” risk subgroups based on their GloboRisk scores and into “BMI ≤ 26 kg/m2”and “BMI > 26 kg/m2” subgroups. Primary efficacy endpoint was between-treatments comparison of HbA1c changes from baseline for these 2 sets of subgroups. Between-treatments comparisons of secondary efficacy and safety endpoints were also performed. We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients. Meanwhile, for patients with BMI ≤ 26 kg/m2, compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target (47.83% vs 28.17%, P = 0.0165) and composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187) and have a slightly better safety profile. In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m2, BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy.

A Japanese Study Assessing Glycemic Control with Use of IDegAsp Co-formulation in Patients with Type2 Diabetes in Clinical Practice: The JAGUAR Study.

IntroductionThe aim of this study was to evaluate the glycemic control and safety of insulin degludec/insulin aspart (IDegAsp) co-formulation in Japanese patients with type 2 diabetes (T2D) in a real-world clinical setting, including elderly patients (aged > 75 years).MethodsPatients (≥ 18 years) diagnosed with T2D, previously treated with insulin were included from the Japanese Medical Data Vision database. Baseline data were taken at the index date, defined as the first IDegAsp prescription claim. Change in glycated hemoglobin (HbA1c) at 12 months was estimated using a mixed model repeated measures analysis. The proportion of patients achieving target HbA1c < 8.0% without experiencing hypoglycemia (identified by International Classification of Disease codes) was calculated at 12 months (365 ± 90 days) after baseline.ResultsOverall, 10,798 patients were included, 3940 were aged > 75 years, and 913 had baseline HbA1c values available. Switching to IDegAsp was associated with significantly improved HbA1c values at 12 months (− 1.23% [− 1.43, − 1.02]95%CI, p < 0.001) versus baseline. Moreover, relative to baseline, a significantly greater proportion of patients achieved HbA1c < 8.0% without hypoglycemia at 12 months, relative rate (RR) 1.30 [1.15, 1.45]95%CI, p < 0.001. Results were similar for patients aged ≤ 75 years and aged > 75 years; 66% and 64% of patients, respectively, achieved HbA1c < 8.0% without hypoglycemia at 12 months.ConclusionSwitching from insulin to IDegAsp co-formulation was associated with significantly improved glycemic control and a reduction in hypoglycemia rate during 12 months of follow-up in Japanese patients with T2D, including those aged > 75 years.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01623-y.

Effectiveness of triple therapy with dapagliflozin add-on to dual therapy over 52 weeks in patients with uncontrolled type 2 diabetes mellitus in a centre of high complexity, Cali-Colombia.

To evaluate the effectiveness of adding dapagliflozin as an intensification strategy for the treatment of patients with uncontrolled type 2 diabetes mellitus (T2DM). A historical cohort study was conducted in 123 adult patients over 18 years old who were diagnosed with uncontrolled T2DM, who received dapagliflozin add-on to their dual base treatment: metformin plus glibenclamide (n = 32), metformin plus saxagliptin (n = 29), metformin plus exenatide (n = 28), or metformin plus insulin (n = 34). The endpoints were evaluated using analysis of variance. All the patients completed a 52-week follow-up. Overall, 52.85% of patients were female, the Hispanic population represented the largest proportion of patients in all groups (60.98%), and the mean ± SD patient age and body weight were 55.05 ± 7.58 years and 83.55 ± 9.65 kg, respectively. The mean ± SD duration of T2DM, glycated hemoglobin (HbA1c), and fasting plasma glucose (FPG) were 5.93 ± 2.98 years, 8.1 ± 0.53%, and 166.03 ± 26.80 mg/dL, respectively. The grand mean changes of HbA1c, FPG, body weight and blood pressure showed a decreasing trend during the study period and it was statistically significant in all groups (p-value = <0.001). The proportion of patients achieving HbA1c target (<7%) was highest in the group that used a dapagliflozin add-on to metformin plus saxagliptin. The addition of dapagliflozin as an alternative for intensification of dual therapy consistently improved, not only FPG and HbA1c, but also body weight and blood pressure, with statistically significant results.

Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies.

IntroductionThis analysis evaluated the efficacy and safety of dulaglutide in Chinese patients with type 2 diabetes (T2D) aged ≥ 60 and < 60 years.MethodsThis post hoc analysis included patients with T2D enrolled in two phase 3 clinical trials AWARD-CHN1 (NCT01644500) and AWARD-CHN2 (NCT01648582) of dulaglutide 0.75 and 1.5 mg. Patients were categorized into two groups (≥ 60 and < 60 years). Efficacy outcomes (change in glycated hemoglobin [HbA1c], fasting blood glucose [FBG], and weight; percentage of patients achieving HbA1c target [< 7.0%]) and safety outcomes (incidence of hypoglycemia and gastrointestinal treatment-emergent adverse events [GI TEAEs]) at 26 weeks were evaluated for each age group in both trials.ResultsA total of 766 patients (≥ 60 years, n = 222; < 60 years, n = 544) were included in the study. A similar reduction of HbA1c was observed in both age groups: AWARD-CHN1, 1.5 mg (least squares mean [LSM] 95% confidence interval [CI] ≥ 60 years: − 1.45% [− 1.69, − 1.21%] and < 60 years: − 1.43% [− 1.59, − 1.28%]) and 0.75 mg (≥ 60 years: − 1.29% [− 1.53, − 1.05%] and < 60 years: − 1.18% [− 1.33, − 1.03%]); AWARD-CHN2, 1.5 mg (≥ 60 years: − 1.60% [− 1.83, − 1.36%] and < 60 years: − 1.64% [− 1.80, − 1.49%]) and 0.75 mg (≥ 60 years: − 1.31% [− 1.55, − 1.08%] and < 60 years: − 1.33% [− 1.48, − 1.17%]). Dulaglutide showed a reduction in HbA1c as early as 4 weeks after initiation of treatment, which was maintained over 26 weeks in both age groups. The percentage of patients achieving HbA1c target < 7.0% at 26 weeks was also similar in both age groups. Incidence of hypoglycemia and GI TEAEs was low in each age group.ConclusionTreatment with once-weekly dulaglutide improved glycemic control in patients with T2D aged ≥ 60 years and < 60 years and was well tolerated in older patients, suggesting it can be considered a safe and effective treatment option for use in older patients with T2D.Trial registrationAWARD-CHN1 (NCT01644500) and AWARD-CHN2 (NCT01648582).Electronic supplementary materialThe online version of this article (10.1007/s13300-020-00910-1) contains supplementary material, which is available to authorized users.

Has Glycaemic Control in Diabetes Mellitus Improved Since the Introduction of Point-of-Care Glycated Haemoglobin A1c?

Abstract Background: The mortality rate from diabetes-related complications in Sub-Saharan Africa surpassed that of HIV/AIDS, tuberculosis and malaria combined. Point-of-care (POC) glycated haemoglobin (HbA1c) has been in routine use at a tertiary hospital's diabetic clinic in Johannesburg, South Africa. This study set out to determine if having a readily available result on the day of consultation has led to improved glycaemic control. Objective: The aim of this study was to determine if an immediately available POC HbA1c would result in more patients achieving target HbA1c compared to previously used laboratory HbA1c. Methods: A retrospective audit of 195 attendees of the diabetic clinic at a public academic hospital who had been attending before the advent of the POC HbA1c test was recruited. The laboratory HbA1c taken on average 5 years before was compared to the current POC HbA1c to determine if there was any improvement in glycaemic control. Results: The mean HbA1c before the POC test was 8.8% (SD 1.9) and the current POC HbA1c was 8.9% (SD 1.94). There was no statistically significant improvement in glycaemic control. Conclusion: The POC test for HbA1c at a tertiary hospital's diabetic clinic did not result in improved glycaemic control. This study has shown that the introduction of new technology alone may not result in better diabetic care. Comprehensive diabetic care is multifactorial and relies on the intensive efforts of a multidisciplinary team including physician and diabetic nurse educator with active patient participation to ensure optimal glycaemic control.

Patient characteristics and 6-month dose of basal insulin associated with HbA1c achievement

The efficacy of basal insulin (BI) for adequate glycemic control in patients with type 2 diabetes mellitus (T2DM) has been well documented by randomized clinical trials. This post hoc analysis of the Observational Registry of Basal Insulin Treatment (ORBIT) study was performed to explore the 6-month dose of BI used in insulin-naïve T2DM patients achieving HbA1c target (<7%) and determine the patient characteristics that affect the 6-month dose of BI in the setting of real-world clinics in China. This multicenter observational registry screened 19 894 adult T2DM patients with inadequately controlled hyperglycemia and treated with oral antidiabetic drugs (OADs) in China. Of these patients, 5191 who continued to receive BI after 6 months and achieved HbA1c target were analyzed. Patient characteristics including age, body weight, fasting plasma glucose (FPG), use of OADs, insulin (type and dose), and glycemic control were recorded at baseline and 6-month follow-ups. The 6-month dose of BI needed for effective glycemic control was 0.20 ± 0.08 U/kg/day. High body mass index, high FPG, young age, longer duration of diabetes or OAD treatment, a greater number of OADs at baseline, and allocation to detemir and glargine were significant independent predictors for high dose of BI at 6 months. This post hoc analysis of the ORBIT registry provides key information on the 6-month dose of BI needed for effective glycemic control in Chinese T2DM patients. Furthermore, it identified crucial patient characteristics that are significant determinants of the dose of BI in a real-world setting.

Control of Glycemia With a Basal-Plus Regimen in People With Type 2 Diabetes Mellitus Insufficiently Controlled by Previous Treatment

Background: Type 2 diabetes mellitus (T2DM) is often characterized by insulin resistance and progressive ?-cell deterioration. With longer duration of T2DM most patients treated with oral antihyperglycemic drugs (OADs), in monotherapy or in combination, will ultimately require basal insulin therapy and even further prandial intensification later on. The basal-plus regimen is one of the proposed approaches for treatment intensification by adding one injection of prandial rapid-acting insulin to basal insulin. The CONBA+ study aimed to collect real-world data of glycemic control of T2DM patients uncontrolled on insulin/OAD therapy using the basal-plus approach in Morocco. Methods: CONBA+ study was a national, prospective, non-interventional, multicenter study involving 50 endocrinologists from Morocco. The study, conducted between June 2015 and June 2017, enrolled T2DM patients uncontrolled on their previous regimen (hemoglobin A1c (HbA1c) ? 7.5% on two OADs, glargine 100 U/mL and OADs or once daily premixed insulin). Patients continued or newly initiated once-daily insulin glargine 100 U/mL (Gla-100) and also received one injection of insulin glulisine (Glu) at the main meal in replacing any previous treatment. Demographics, glycated hemoglobin (HbA1c), fasting blood glucose (FBG), postprandial glucose (PPG), insulin doses and the frequency of hypoglycemia were assessed at baseline and at 12 and 24 weeks after study entry. Results: Overall, 854 people (46.8% men) fulfilled the inclusion criteria. At baseline, mean age was 59.0 ± 9.4 years, mean duration of diabetes 10.8 ± 6.7 years (range: 1 - 45 years), mean body mass index (BMI) 27.4 ± 4.0 kg/m 2 and mean HbA1c 9.50±1.51%. After 24 weeks, 33.0% of patients achieved target HbA1c < 7.0% (primary endpoint). In addition, mean FPG and postprandial blood glucose (PPBG) improved significantly at week 24 (change from baseline: -88 mg/dL and -108 mg/dL respectively; P < 0.001) while the number of reported severe hypoglycemia was low. Conclusions: The use of a basal-plus regimen consisting of insulin glargine 100 U/mL and insulin glulisine injected at the main meal resulted in significant improvements of glycemic parameters. In addition, the basal-plus approach showed a good safety profile with a low risk of hypoglycemia. J Endocrinol Metab. 2020;10(1):16-22 doi: https://doi.org/10.14740/jem548

Efficacy of Dulaglutide as a First Injectable Option for Patients with Type 2 Diabetes: A Post-Hoc Pooled Analysis.

IntroductionThe ADA-EASD consensus report recommends using glucagon-like peptide-1 receptor agonists (GLP-1RAs) as the first injectable therapy prior to basal insulin in most patients with type 2 diabetes (T2D) not at glycemic goals after oral anti-hyperglycemia medications (OH). The objective of this analysis was to assess the glycemic efficacy of once-weekly dulaglutide 1.5 mg in patients with T2D when added on a background of commonly used OH regimens.MethodsPatients from seven phase 3 AWARD [Assessment of Weekly AdministRation of LY2189265 (Dulaglutide) in Diabetes] trials, where once-weekly dulaglutide 1.5 mg was added to OHs, were pooled into the following categories based on OH regimens: metformin (MET), sulfonylurea (SU), MET + SU, MET + pioglitazone, and MET + SGLT2i. Change from baseline in glycated hemoglobin A1c (HbA1c), fasting serum glucose and body weight, proportion of patients reaching target HbA1c < 7%, and safety parameters were assessed.ResultsA total of 1784 patients treated with once-weekly dulaglutide 1.5 mg were included in this analysis. Baseline characteristics of the overall population were (mean ± standard deviation): age, 55.4 ± 9.8 years, HbA1c: 8.2 ± 1.0%, body mass index: 31.4 ± 5.4 kg/m2, duration of diabetes: 8.0 ± 5.6 years, and 878 (49.2%) were female. At 6 months, the addition of once-weekly dulaglutide 1.5 mg to various OH regimens significantly reduced HbA1c (− 1.3 to − 1.6%) and fasting blood glucose (− 29 to − 45 mg/dl) from baseline in all groups (p < 0.001), with 39–61% and 52–76% of these patients achieving HbA1c targets of ≤ 6.5% and < 7%, respectively. Significant reductions in body weight (− 0.8 to − 2.9 kg) were also observed in all groups (p < 0.001). Nausea, vomiting, and diarrhea were reported by 10–35%, 4–19%, and 6–28% of patients, respectively. Severe hypoglycemia occurred in one patient (MET + SU).ConclusionThe addition of a once-weekly GLP-1RA, dulaglutide, demonstrated clinically meaningful HbA1c reduction in patients with T2D on different background OH regimens, making it an effective first injectable option.FundingEli Lilly and Company.Electronic supplementary materialThe online version of this article (10.1007/s13300-019-00709-9) contains supplementary material, which is available to authorized users.

Efficacy and safety of evogliptin versus sitagliptin as an add-on therapy in Indian patients with type 2 diabetes mellitus inadequately controlled with metformin: A 24-week randomized, double-blind, non-inferiority, EVOLUTION INDIA study

AimThis study aimed to assess efficacy and safety of evogliptin versus sitagliptin, when added to background metformin therapy in Indian patients with uncontrolled type 2 diabetes. MethodOverall, 184 patients with uncontrolled type 2 diabetes (7% ≤ HbA1c < 10%) receiving ≥8 weeks of stable metformin monotherapy (≥1 g/day), were randomized to receive add-on treatment (evogliptin 5 mg or sitagliptin 100 mg) for 24 weeks. Primary endpoint was change in HbA1c from baseline to 12 weeks (non-inferiority margin: <0.35). ResultsMean reductions in HbA1c at 12 weeks in evogliptin- and sitagliptin-treated patients were −0.37 (1.06) and –0.32 (1.14), respectively. The adjusted mean difference between treatment groups was –0.022 (95% CI: –0.374, 0.330; P = 0.901), that demonstrated non-inferiority. Reductions in FPG and PPG were similar between evogliptin and sitagliptin at 12 and 24 weeks. Changes in body weight were comparable between the treatment groups. Patients achieving target HbA1c < 7.0% (evogliptin, 26.7% vs. sitagliptin, 20%) was almost equal in both groups. Treatment-emergent adverse events occured in 52 patients (evogliptin, 25% and sitagliptin, 31.5%) and were generally mild. ConclusionsEvogliptin was non-inferior to sitagliptin in HbA1c reduction. It effectively improved glycemic control and was well tolerated in type 2 diabetes patients inadequately controlled by metformin alone.

A Cross-sectional Retrospective Analysis of Glycemic Burden and Nephropathy in an Indian Population and Formulation of a New Plan Using eGFR/HbA1c Grid Formation.

BackgroundDiabetes is a metabolic, non-communicable disease (NCD) that represents one of the major causes of morbidity and mortality worldwide. India has a huge burden of chronic kidney disease (CKD) that is associated with diabetes.Materials and methodsCross-sectional data were collected for a total of 241 patients from the authors’ clinic record. A new approach for the management of patients with diabetes was proposed using a grid system, where we need to consider the Hemoglobin A1C (HbA1c) and estimated glomerular filtration rate (eGFR) values of the patient and assign a zone (green, blue, orange or red) and subsequently decide an appropriate treatment according to the assigned zone.ResultsWe found that 20.73% of patients had decreased eGFR and only 31.12% of patients achieved target HbA1c level. A high prevalence of diabetic nephropathy (20.73%) was observed in this study population. A statistically significant difference among the four groups (zones) with respect to age (p <0.001), duration of diabetes (p = 0.024), HbA1c (p <0.001), and eGFR (p <0.001) was found.ConclusionThe burden of diabetes and nephropathy is high in low-income countries and can be easily assessed by applying simple tools such as the newly proposed HbA1c/eGFR grid system to identify high-risk and medium-risk patients and adopting treatment according to the assigned zone.

Effect of hypomagnesaemia on glycaemic control of type II diabetes mellitus

Insulin therapy induces weight gain but whether it causes long term adverse metabolic and CV outcomes in obese patients remains unclear.A retrospective cohort study of 12,725 insulin initiators with T2D derived from UK General Practices. Multivariate linear, logistic regression analyses and Cox proportional hazard models were used to estimate HbA1c, BMI, risk of composite CV events between baseline BMI categories at 5 years.Mean age was 58.6 ± 13.8 years. The proportion of patients achieving HbA1c targets decreased across increasing BMI categories at 6 and at 12 months; p = 0.0001, but not significant beyond 24 months. 1095 composite events of all-cause mortality, non-fatal stroke and MI occurred with an adjusted hazard risk (aHR) relative to normal of: (1.10; 95%CI: 0.90–1.35) in the overweight, (1.05; 95%CI: 0.86–1.29) in the obese class I, (1.03; 95%CI: 0.83–1.29) in the obese class II and (1.30; 95%CI: 1.02–1.66) in the obese class III BMI categories.Among patients with T2D insulin initiators, obesity adversely influences HbA1c up to 12 months, but not beyond 24 months and is associated with a decrease in BMI compared to non-obese groups. Morbidly obese patients initiating insulin have 30% increased risk of composite CV events after 5 years.

Therapy Optimization with Once Daily Glargine Gla-300–Based Therapy in Patients Insufficiently Controlled on Premixed Insulins or Twice Daily Basal Regimens—Real-Life Data

Introduction: In Slovenia, as in many Central Europe countries, there is a high share of patients with T2D treated with human basal and premixed insulins. Many of them are often sub optimally controlled. One barrier to the achievement of optimal glycaemic control is the risk of hypoglycaemia, a common side effect of insulin therapy. Gla-300 is a new formulation of insulin glargine delivering the same amount of insulin as insulin glargine 100 units/mL (Gla-100) in a 1/3 volume. Pharmacokinetic and pharmacodynamic action profiles of Gla-300 are more constant and prolonged compared with Gla-100, due to a more gradual and extended release of glargine from the subcutaneous depot which allows continued blood glucose control beyond 24 hours. Study Design: We performed a retrospective, observational study. We have obtained data from medical charts of T2D and T1D patients, who initiated Gla-300 in the period from May 1st, 2016 to June 1st, 2017. The primary objective was to evaluate a real-life efficacy of once daily Gla-300 basal insulin therapy in patients insufficiently controlled on premixed insulins or twice- daily basal regimens, defined as the mean change in HbA1c value 3 or 6 months after the switch. The secondary objective was relationship between the occurrence of hypoglycaemia before and after the switch. Results: Data from 107 patients on Gla-300 have been analysed. Switching to insulin Gla-300 significantly reduced HbA1c (∆ -1.0%, p=0.000), FPG (∆ - 1.7mmol/l, p=0.000) and PPG (∆ -2.8mmol/l, p=0.000). More patients achieved target HbA1c concentrations (≤ 7%) after the switch to Gla-300 (8.4% before vs. 32% after the switch). 90.2% of subjects reported reduced number of hypoglycaemic events after switching to Gla-300. Conclusion: Switching to insulin Gla-300 proved to be safe and effective for patients with both, T1D and T2D. Disclosure J. Komel: Research Support; Self; Novo Nordisk Inc.. Other Relationship; Self; Sanofi, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company. D. Fabcic: None. K. Vukelic: None.

Relative Contribution of Fasting and Postprandial Blood Glucose in Overall Glycemic Control: Post Hoc Analysis of a Phase IV Randomized Trial.

IntroductionFew prospective clinical trials have investigated the role of fasting blood glucose (FBG) and/or postprandial glucose (PPG) in assessing overall glycemic control by using different insulin regimens. In the present post hoc analysis, we assessed the contribution of FBG and/or PPG in overall glycemic control in Chinese patients under insulin treatment.MethodsCLASSIFY is a phase IV, randomized, open-label, 26-week, parallel-arm, treat-to-target, multinational, controlled study in patients with type 2 diabetes mellitus to compare the efficacy and safety of insulin lispro mix 25 (LM25) and insulin lispro mix 50 (LM50) as starter insulins. Insulin was titrated with an aim to target pre-meal blood glucose (BG) levels at > 3.9 and ≤ 6.1 mmol/L before breakfast and dinner. The primary outcome assessed was the change in HbA1c from baseline.ResultsChinese patients contributed 38.7% (N = 156) of the total population. The majority of patients were male (52.6%). The mean (SD) body mass index was 24.54 (3.04) kg/m2 and mean (SD) HbA1c was 8.54 (1.10) % at baseline. At week 26, LM50 showed a significantly greater reduction from baseline in HbA1c (− 2.03% vs − 1.55%, P < 0.001), average daily BG (− 3.21 vs − 2.34 mmol/L, P < 0.001), average post-meal BG (− 3.58 vs − 2.39 mmol/L, P < 0.001), and average prandial BG excursion (− 1.01 vs − 0.22 mmol/L, P = 0.006) than the LM25 group. The reductions in average pre-meal BG (− 2.59 vs − 2.28 mmol/L, P = 0.137) were not significantly different between the groups. The proportion of patients achieving HbA1c targets (< 7% or ≤ 6.5%) without nocturnal hypoglycemia or weight gain was greater (P < 0.05) with LM50 compared with LM25.ConclusionLM50 achieved better overall glycemic control than LM25 as a starter insulin in Chinese patients, which may be due to greater improvement in PPG levels.Trial RegistrationClinicaltrials.gov identification number: NCT01773473.FundingEli Lilly and Company, Shanghai, China.

Effects of obesity on metabolic and cardiovascular outcomes following insulin initiation in patients with type 2 diabetes

Insulin therapy induces weight gain but whether it causes long term adverse metabolic and CV outcomes in obese patients remains unclear. A retrospective cohort study of 12,725 insulin initiators with T2D derived from UK General Practices. Multivariate linear, logistic regression analyses and Cox proportional hazard models were used to estimate HbA1c, BMI, risk of composite CV events between baseline BMI categories at 5 years. Mean age was 58.6±13.8years. The proportion of patients achieving HbA1c targets decreased across increasing BMI categories at 6 and at 12 months; p=0.0001, but not significant beyond 24 months. 1095 composite events of all-cause mortality, non-fatal stroke and MI occurred with an adjusted hazard risk (aHR) relative to normal of: (1.10; 95%CI: 0.90-1.35) in the overweight, (1.05; 95%CI: 0.86-1.29) in the obese class I, (1.03; 95%CI: 0.83-1.29) in the obese class II and (1.30; 95%CI: 1.02-1.66) in the obese class III BMI categories. Among patients with T2D insulin initiators, obesity adversely influences HbA1c up to 12 months, but not beyond 24 months and is associated with a decrease in BMI compared to non-obese groups. Morbidly obese patients initiating insulin have 30% increased risk of composite CV events after 5 years.

Glycemic control in Type 2 Diabetes patients attending a clinic in Vijayawada, a South Indian city

Objective: Andhra Pradesh (A.P), a southern state in India, is faced with a significant burden of diabetes. Few studies are there mentioning the prevalence in some parts of the state and as a state as a whole. There is limited information regarding the glycemic control of these patients. We analyzed the status of glycemic control in a sample of patients attending a diabetic clinic, based at Vijayawada, a major city in A.P. Methods: Data from patient records was collected for those with first visit during 2006 and analyzed for glycemic parameters at first visit and at 10 year follow up. Results: A total of 104 Type 2 Diabetes Mellitus patients details have been considered for the study. Mean age of the sample at first visit is 51.2 years. Mean duration of follow up is 9.7 years. During this follow up the mean HbA1C is reduced significantly from 9.5 % at first visit to 7.8% at latest visit (?HbA1C=1.72, P<0.001). FBS and PPBS are also reduced significantly by 17.6 mg/dl (P<0.01) and 28.2 mg/dl (P<0.01) respectively. Proportion of patients achieving HbA1C target of less than 6.5%, 7% and 7.5% are 18%, 29% and 30% respectively at the latest visit. There is a slight increase in weight by 2 kg and a change of BMI by 0.98 kg/m 2 between first and latest visit. Conclusion: Glycemic control in this clinic is satisfactory in terms of HbA1C control and proportion of patients achieving target.