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Does glycemic control offer similar benefits among patients with diabetes in different regions of the world? Results from the ADVANCE trial.

ABSTRACT: Participants in ADVANCE were drawn from many countries. We examined whether the effects of intensive glycemic control on major outcomes in ADVANCE differ between participants from Asia, established market economies (EMEs), and eastern Europe.ADVANCE was a clinical trial of 11,140 patients with type 2 diabetes, lasting a median of 5 years. Demographic and clinical characteristics were compared across regions using generalized linear and mixed models. Effects on outcomes of the gliclazide modified release-based intensive glucose control regimen, targeting an HbA(lc) of ?6.5%, were compared across regions using Cox proportional hazards models.When differences in baseline variables were allowed for, the risks of primary outcomes (major macrovascular or microvascular disease) were highest in Asia (joint hazard ratio 1.33 [95% CI 1.17-1.50]), whereas macrovascular disease was more common (1.19 [1.00-1.42]) and microvascular disease less common (0.77 [0.62-0.94]) in eastern Europe than in EMEs. Risks of death and cardiovascular death were highest in eastern Europe, and the mean difference in glycosylated hemoglobin between the intensive and standard groups was lowest in EMEs. Despite these and other differences, the effects of intensive glycemic control were not significantly different (P ? 0.23) between regions for any outcome, including mortality, vascular end points, and severe hypoglycemic episodes.Irrespective of absolute risk, the effects of intensive glycemic control with the gliclazide MR-based regimen used in ADVANCE were similar across Asia, EMEs, and eastern Europe. This regimen can safely be recommended for patients with type 2 diabetes in all of these regions.

SUBMITTER: Woodward M

PROVIDER: S-EPMC3220831 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Does glycemic control offer similar benefits among patients with diabetes in different regions of the world? Results from the ADVANCE trial.

Woodward Mark M Patel Anushka A Zoungas Sophia S Liu Lisheng L Pan Changyu C Poulter Neil N Januszewicz Andrzej A Tandon Nikhil N Joshi Prashant P Heller Simon S Neal Bruce B Chalmers John J

Diabetes care 20111004 12

<h4>Objective</h4>Participants in ADVANCE were drawn from many countries. We examined whether the effects of intensive glycemic control on major outcomes in ADVANCE differ between participants from Asia, established market economies (EMEs), and eastern Europe.<h4>Research design and methods</h4>ADVANCE was a clinical trial of 11,140 patients with type 2 diabetes, lasting a median of 5 years. Demographic and clinical characteristics were compared across regions using generalized linear and mixed ...[more]

PMID: 21972410

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Project description:INTRODUCTION:The stable, ultra-long duration of action of insulin degludec (degludec) minimizes fluctuations in glucose-lowering activity over the daily (24-h) dosing period, and comparative studies with other basal insulins suggest that these properties translate into a lower risk of hypoglycemia at equivalent levels of glycemic control. Results from the real-world European multicenter, retrospective chart review study of 2550 patients with type 1 and type 2 diabetes (T1D and T2D) in routine clinical care EU-TREAT (NCT02662114) showed that patients benefited from improved glycemic control and significantly reduced rates of hypoglycemia following a switch to degludec. METHODS:In this post hoc analysis, EU-TREAT patients were stratified into good (≤ 7.5% HbA1c), intermediate (> 7.5 to ≤ 8.5% HbA1c), and poor (> 8.5% HbA1c) glycemic control at baseline to investigate the possibility of differential benefits, either improved control or reduced risk of hypoglycemia, whichever the need. Changes in HbA1c, overall hypoglycemia, and total insulin dose from baseline to 6 and 12 months follow-up were assessed for each group. RESULTS:For both T1D and T2D patients, those in good initial control experienced significant reductions in rates of hypoglycemia and total insulin dose following the switch, without compromising control. Those in poor initial control achieved significant improvements in HbA1c with no change in rates of hypoglycemia or total insulin dose. CONCLUSION:This analysis expands the findings of EU-TREAT by showing differential changes in the clinical endpoints depending on particular need. It introduces the possibility that the differential benefits of degludec could address two of the renowned clinical challenges faced when treating diabetes: improving glycemic control for optimal management of T1D and titrating insulin dose in T2D, both without fear of increased hypoglycemia. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02662114. FUNDING:Novo Nordisk A/S.

Project description:BackgroundAmong self-care measures, the self-monitoring of blood glucose (SMBG) is a critical component for checking blood glucose levels. In addition, there is growing evidence suggesting that digital technologies are being adopted as an additional method for health care systems to increase patient contact. However, for patients with non-insulin-treated diabetes mellitus type 2 (DMT2), the value of SMBG was inconsistent among studies, and the evidence for digital technologies from real-world clinical practice is still limited.ObjectiveOur study aimed to assess patients with non-insulin-treated DMT2 who were receiving care from a single clinic and analyze whether the use of a diabetes management app and SMBG behavior would affect glycemic control in a real-world clinical setting.MethodsWe collaborated with a large clinic focused on diabetes care in Taiwan that had been using the Health2Sync mobile app and web-based Patient Management Platform to collect the data. The patients were divided into 2 groups (app-engaged-user group and only-data-uploader group) according to different activities in the app, and blood glucose was recorded every month from 1 to 6 months after registration in the app. A sample of 420 patients was included in the analysis, and a linear mixed model was built to investigate which factors affected the patients' blood glucose percentage change.ResultsUsing the mixed model coefficient estimates, we found that the percentage change was significantly negative when the only-data-uploader group was set as the baseline (t=-3.873, df=1.81 × 104; P<.001 for the patients of the app-engaged-user group). We found that for patients with shorter diabetes duration, their blood glucose decreased more than patients with longer diabetes duration (t=2.823, df=1.71 × 104; P=.005 for the number of years of diabetes duration). In addition, we found that for younger patients, their blood glucose decreased more than older patients (t=2.652, df=1.71 × 104; P=.008 for the age of the patients). Furthermore, the patients with an education level of junior high school or lower saw a significantly greater decrease in blood glucose percentage change than the patients with an education level of senior high school or higher (t=4.996, df=1.72 × 104; P<.001 for the patients with an education level of senior high school or higher). We also found that the count of blood glucose measured enlarged the decrease along the interaction months (t=-8.266, df=1.97 × 104; P<.001 for the nth month × the count of blood glucose in the nth month). Lastly, the gender of the patients did not significantly affect the percentage change (t=0.534, df=1.74 × 104; P=.59 for female patients).ConclusionsOur analysis showed the following: the blood glucose percentage change of the patients in the app-engaged-user group dropped more than that in the only-data-uploader group; shorter diabetes duration is associated with a steeper decrease in the patients' blood glucose percentage change; the percentage decrease in blood glucose change in younger patients is greater than older patients; the blood glucose percentage change of the patients with an education level of junior high school or lower dropped more than those with an education level of senior high school or higher; and the more frequently the patients test SMBG each month, the greater the decrease in the patients' blood glucose percentage. Further studies can be performed to consider the differences in daily behaviors such as exercise and diet across the patients and whether these factors could have vital effects on glycemic control.

Project description:ObjectiveThis post-hoc analysis of the EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed inter-regional differences in baseline characteristics and response to treatment intensification with dual oral antidiabetes drugs (OADs) in patients with type 2 diabetes mellitus (T2DM).MethodsPatients with T2DM inadequately controlled with first-line monotherapy were assigned to receive a dipeptidyl peptidase-4 (DPP-4) inhibitor, vildagliptin, or comparator OADs as add-on dual therapy. The primary effectiveness end point (PEP) was achieving glycated hemoglobin (HbA1c) reduction >0.3% without hypoglycemia, peripheral edema, discontinuation owing to gastrointestinal events or weight gain ⩾5% at 12 months. The secondary effectiveness end point (SEP) was achieving HbA1c of <7% without hypoglycemia or weight gain ⩾3% at 12 months.ResultsBaseline characteristics of patients (N=43 791), including mean HbA1c (8.2%), varied across regions. Baseline age (62.3 years) and T2DM duration (6.3 years) were greater in patients from Europe than those from India and the Middle East (age: 51.8 and 52.1 years; T2DM duration: 4.3 and 4.2 years, respectively). The probability of achieving PEP with dual therapy was higher in India (odds ratio (OR): 1.5), Latin America (OR: 1.2) and Middle East (OR: 2.0) than in Europe (OR: 0.8) and East Asia (OR: 0.3). Achievement of SEP in patients receiving dual therapy was greater in Latin America (OR: 1.7) and Middle East (OR: 1.7). Vildagliptin add-on therapy allowed more patients to achieve SEP across regions. Women aged ⩾45 years less often attained glycemic target (HbA1c<7%) without significant weight gain ⩾5% compared with women aged <45 years (OR: 0.876, 95% confidence interval: 0.774, 0.992; P=0.037).ConclusionsBaseline HbA1c and T2DM duration differed considerably across all regions. Treatment intensification with second OAD, particularly with a DPP-4 inhibitor vildagliptin, resulted in good treatment response without tolerability issues despite delayed intensification of failing monotherapy across regions.

Project description:IntroductionTreatments like glucagon-like peptide-1 receptor agonists carry low hypoglycemia risk and are recommended for elderly patients with type 2 diabetes (T2D), while some routine treatments, like insulin, increase hypoglycemia risk. The DISPEL-Advance (Dulaglutide vs Basal InSulin in Injection Naïve Patients with Type 2 Diabetes: Effectiveness in ReaL World) study compared glycemic outcomes, healthcare resource utilization, and costs in elderly patients with T2D who initiated treatment with dulaglutide versus those initiating treatment with basal insulin.MethodsThis observational, retrospective cohort study used data from the Optum Research Database. Medicare Advantage patients (≥ 65 years) with T2D were assigned to dulaglutide or basal insulin cohorts based on pharmacy claims and propensity score matched on demographic and baseline characteristics. Change in HbA1c, 12-months follow-up HbA1c, and follow-up all-cause and diabetes-related healthcare resource utilization and costs were compared.ResultsPropensity score matching yielded well-balanced cohorts with 1891 patients each (mean age: dulaglutide, 72.09 years; basal insulin, 72.56 years). The dulaglutide cohort had significantly greater mean HbA1c reduction from baseline to follow-up than basal insulin cohort (- 0.95% vs - 0.69%; p < 0.001). The dulaglutide cohort had significantly lower mean all-cause and diabetes-related medical costs (all-cause: $8306 vs $12,176; diabetes-related: $4681 vs $7582 respectively; p < 0.001) and lower mean all-cause total costs ($18,646 vs $20,972, respectively; p = 0.007) than basal insulin cohort. The dulaglutide cohort had significantly lower all-cause and diabetes-related total costs per 1% change in HbA1c than basal insulin cohort (all-cause: $19,729 vs $30,334; diabetes-related: $12,842 vs $17,288, respectively; p < 0.001).ConclusionsElderly patients with T2D initiating dulaglutide had greater HbA1c reduction, lower mean all-cause medical and total costs, lower diabetes-related medical costs, and lower total all-cause and diabetes-related costs per 1% change in HbA1c than patients initiating basal insulin. Future studies assessing medications that do not increase hypoglycemia risk could help inform therapeutic strategies in elderly patients.

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Does glycemic control offer similar benefits among patients with diabetes in different regions of the world? Results from the ADVANCE trial.

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Does glycemic control offer similar benefits among patients with diabetes in different regions of the world? Results from the ADVANCE trial.

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