Predictors for achieving target glycemic control in Japanese patients with type 2 diabetes after initiation of basal supported oral therapy using insulin glargine: sub-analysis of the ALOHA2 study, drug use surveillance in Japan.
ABSTRACT: Objectives:We aimed to identify diabetes-related factors associated with achieving HbA1c <7.0 % after the initiation of basal supported oral therapy (BOT) in insulin-naïve type 2 diabetes patients with an HbA1c value of ?6.5 % during the previous 4 weeks, using data from Add-on Lantus® to Oral Hypoglycemic Agents 2 (ALOHA2) study, a 24-week observational study on Japanese type 2 diabetes patients. Methods:Patients were categorized into two groups: HbA1c <7.0 % at the final evaluation point (at 24 weeks or the last visit) as HbA1c-target-achieved; HbA1c ?7.0 % as target-not-achieved. Associations between baseline factors and HbA1c <7.0 % achievement were explored using logistic regression. Results:Of the 1520 patients in the study, 400 patients (26.3 %) achieved HbA1c <7.0 %. Patients with diabetes duration of <1 year and between ?1 and <2 years [odds ratio (OR): 5.27, 95 % confidence interval (CI): 1.13-24.51; OR: 3.77, 95 % CI 1.19-11.93, respectively], those on one pre-study orally administered antidiabetic agent (OAD) (OR: 2.42, 95 % CI 1.12-5.22), and those with absence of diabetic neuropathy (OR: 2.54, 95 % CI 1.12-5.76) were more likely to achieve HbA1c <7.0 % than those with duration of ?15 years, ?4 pre-study OADs, and neuropathy, respectively. Achievement of HbA1c <7.0 % among patients increased by approximately 20 % for each 1 % decrease in HbA1c level at baseline. Conclusions:Shorter diabetes duration, pre-study regimen of one OAD, absence of neuropathy, and lower HbA1c level at baseline were associated with achievement of HbA1c <7.0 %, suggesting that earlier initiation of BOT leads to good HbA1c control in insulin-naïve Japanese type 2 diabetes patients, consistent with our early ALOHA study.
Project description:BACKGROUND: The prevalence of type 2 diabetes mellitus (T2DM) is increasing rapidly among Chinese adults, and limited data are available on T2DM management and the status of glycemic control in China. We assessed the efficacy of oral antidiabetes drugs (OADs), glucagon-like peptide-1 (GLP-1) receptor agonists, and insulin for treatment of T2DM across multiple regions in China. METHODS: This was a multicenter, cross-sectional survey of outpatients conducted in 606 hospitals across China. Data from all the patients were collected between April and June, 2011. RESULTS: A total of 238,639 patients were included in the survey. Eligible patients were treated with either OADs alone (n=157,212 [65.88%]), OADs plus insulin (n=80,973 [33.93%]), or OADs plus GLP-1 receptor agonists (n=454 [0.19%]). The OAD monotherapy, OAD + insulin, and OAD + GLP-1 receptor agonist groups had mean glycosylated hemoglobin (HbA1c) levels (±SD) of 7.67% (±1.58%), 8.21% (±1.91%), and 7.80% (±1.76%), respectively. Among those three groups, 34.63%, 26.21%, and 36.12% met the goal of HbA1c <7.0%, respectively. Mean HbA1c and achievement of A1c <7.0% was related to the duration of T2DM. CONCLUSIONS: Less than one third of the patients had achieved the goal of HbA1c <7.0%. Glycemic control decreased and insulin use increased with the duration of diabetes.
Project description:AIM:To evaluate the effectiveness and safety of initiating basal insulin-supported oral therapy (BOT) with insulin glargine 300?U/mL (Gla-300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs). MATERIALS AND METHODS:This non-interventional, multi-centre, prospective 52-week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla-300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target. RESULTS:Of 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12?months of Gla-300 treatment. Twelve months after starting Gla-300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ?110?mg/dL. Mean HbA1c decreased by -1.22%?±?1.05% to 7.28%?±?0.92% and mean FPG by -51.5 (±48.63) mg/dl to 132.9?±?33.0?mg/dL. Median duration of HbA1c target achievement was 341?days and probability to remain on target after 6?months was 81%. Hypoglycaemia incidence and rates remained low after 12?months of Gla-300 treatment; no severe or severe nocturnal hypoglycaemia was observed. Body weight remained unchanged. CONCLUSIONS:Starting a BOT regimen with Gla-300 allowed about 60% of 721 German and Swiss patients with inadequately controlled type 2 diabetes to achieve glycaemic control within 12?months in daily clinical practice. Glycaemic control was achieved without weight gain or increased risk of nocturnal or severe hypoglycaemia.
Project description:INTRODUCTION: This study aimed to assess treatment satisfaction and self-reported health status in insulin-naïve patients with type 2 diabetes mellitus (T2DM) who started insulin glargine basal-supported oral therapy (BOT) with glycated hemoglobin (HbA1c) value of ?6.5%, using data from Add-on Lantus(®) to Oral Hypoglycemic Agents 2 (ALOHA2) study, a 24-week single-arm, observational study of Japanese patients with T2DM, conducted as drug use surveillance in Japan. METHODS: Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and change version (DTSQc) and self-reported health status using EuroQol 5 Dimension (EQ-5D). The results were compared between the groups stratified by HbA1c level at the final evaluation point: target-achieved (<7.0%) and target-not-achieved groups (?7.0%). RESULTS: In 1251 patients (336 in the target-achieved group), scores of DTSQs, DTSQc, and EQ-5D indicated significant improvement from baseline to the final evaluation point (both P < 0.01). The mean change in DTSQs scale score, DTSQs item score, and EQ-5D index score, and mean DTSQc scale score were significantly improved in the target-achieved group compared with the target-not-achieved group (P < 0.05 for all). DTSQs scale score and HbA1c level showed the same pattern of chronological change. Data analysis in patients stratified by DTSQs score showed better glycemic control in the high satisfaction group. CONCLUSION: Following insulin glargine BOT introduction, treatment satisfaction and health status were improved from patients' perspectives despite the need for daily injections. Based on the possible association between HbA1c 7.0% level achievement, treatment satisfaction, and health status, better glycemic control may be a key to successful treatment.
Project description:To explore the treatment outcomes in adult patients with type 2 diabetes (T2D) enrolled in the GetGoal trials of lixisenatide (LIXI), and the predictive effects of baseline characteristics on outcomes.This study was a pooled analysis of patient-level data from the LIXI GetGoal studies comparing LIXI and placebo. Patients were divided into baseline therapy groups: those receiving oral antidiabetes drugs (OADs) at baseline (n = 2760) or those receiving basal insulin at baseline (n = 1198).Compared with placebo, LIXI treatment led to significantly greater reductions in glycated haemoglobin (HbA1c), and greater achievement of the composite endpoint of HbA1c <7.0% (53 mmol/mol) with no symptomatic hypoglycaemia and no weight gain in either the OAD (34% vs 18%; P < .0001) or the basal insulin groups (19% vs 10%; P < .0001). Treatment with LIXI was associated with a greater percentage of patients experiencing a symptomatic hypoglycaemic event compared with placebo in both the OAD (5% vs 3%; P = .0098) and basal insulin groups (27% vs 17%; P < .0001). In assessing baseline factors that were predictors of treatment outcomes, only baseline HbA1c and LIXI treatment were strong predictors of outcomes in both the OAD and basal insulin groups. No other baseline characteristic had such a large or consistent clinically relevant predictive effect across treatment outcomes.The results from this study show that irrespective of baseline characteristics, LIXI treatment, as an add-on to OAD or basal insulin therapy, is effective in reducing HbA1c and achieving composite endpoints.
Project description:This subgroup analysis of data from the 16-week Lantus Registry Study in China investigated the characteristics of patients with type 2 diabetes mellitus (T2DM) associated with clinical benefits of transitioning therapy from premixed insulin to insulin glargine (100 U/ml) plus oral antidiabetic drugs (OADs).The modified intention-to-treat population of the Lantus Registry Study, comprising 1847 patients with T2DM, were included in the current subgroup analyses. Enrolled patients were divided into subgroups based on efficacy variables of endpoint glycated hemoglobin (HbA1c), endpoint fasting plasma glucose (FPG), and change in HbA1c from baseline. The baseline characteristics of those who did and did not achieve HbA1c <7.0% were compared, as were those with improvement, no change, or deterioration in HbA1c. Characteristics of patients who were unable to achieve HbA1c <7.0%, further grouped according to whether or not they achieved FPG ≤6.1 mmol/L, were also compared. Logistic regression analysis was used to identify factors associated with achieving HbA1c <7.0%.Comparison between subgroups demonstrated that patients with endpoint HbA1c <7.0% were significantly younger, with a shorter duration of diabetes and lower baseline FPG, HbA1c, body mass index, and dose of premixed insulin than patients with endpoint HbA1c ≥7.0%. Logistic regression analysis revealed a negative correlation between baseline age, HbA1c, FPG, and duration of diabetes with achieving HbA1c <7.0%. When stratified according to change in HbA1c, the improvement group was younger, with higher baseline HbA1c and a greater number of patients with duration of diabetes ≤5 years. Three-quarters of patients unable to achieve HbA1c <7.0% also failed to reach FPG ≤6.1 mmol/L.Younger patients with a shorter duration of diabetes and lower HbA1c, FPG, and premixed insulin dose following a switch in treatment to insulin glargine (100 U/ml) plus OADs from premixed insulin have greater potential to achieve HbA1c <7.0%. Poorly controlled patients with higher baseline HbA1c are most likely to experience an improvement in HbA1c following the switch in therapy. The majority of patients unable to achieve HbA1c <7.0% also failed to reach FPG ≤6.1 mmol/L, highlighting the importance of adequate titration of insulin glargine to achieve adequate FPG control, which can enable achievement of target HbA1c.Sanofi.
Project description:Diagnosed diabetes mellitus (DM) is a consistently documented risk factor for ischemic stroke in patients with atrial fibrillation (AF).The purpose of this study was to assess the association between duration of diabetes and elevated hemoglobin A1c (HbA1c) with risk of stroke among diabetic patients with AF.We assessed this association in the ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) California community-based cohort of AF patients (study years 1996 to 2003) where all events were clinician adjudicated. We used Cox proportional hazards regression to estimate the rate of ischemic stroke in diabetic patients according to time-varying measures of estimated duration of diabetes (?3 years compared with <3 years) and HbA1c values (?9.0% and 7.0% to 8.9% compared with <7.0%), focusing on periods where patients were not anticoagulated.There were 2,101 diabetic patients included in the duration analysis: 40% with duration <3 years and 60% with duration ?3 years at baseline. Among 1,933 diabetic patients included in the HbA1c analysis, 46% had HbA1c <7.0%, 36% between 7.0% and 8.9%, and 19% ?9.0% at baseline. Duration of diabetes ?3 years was associated with an increased rate of ischemic stroke compared with duration <3 years (adjusted hazard ratio [HR]: 1.74, 95% confidence interval [CI]: 1.10 to 2.76). The increased stroke rate was observed in older (age ?75 years) and younger (age <75 years) individuals. Neither poor glycemic control (HbA1c ?9.0%, adjusted HR: 1.04, 95% CI: 0.57 to 1.92) nor moderately increased HbA1c (7.0% to 8.9%, adjusted HR: 1.21, 95% CI: 0.77 to 1.91) were significantly associated with an increased rate of ischemic stroke compared with patients who had HbA1c <7.0%.Duration of diabetes is a more important predictor of ischemic stroke than glycemic control in patients who have diabetes and AF.
Project description:Previous research has found that the percentage of US adults with diabetes achieving a glycated hemoglobin (HbA1c) target of <7.0% with currently available treatments has been fairly constant from 2003 to 2010, remaining at just over 50% . The objective of this study was to compare the most recent data (2011-2014) with earlier data to track progress on HbA1c target achievement, for both the general target of <7.0% and inferred individualized targets based on age and the presence of complications.Data from 2677 adults with self-reported diabetes from the National Health and Nutrition Examination Survey (NHANES) from 2007 to 2014 were examined to determine the percentage of adults who achieved HbA1c targets of <7% and an individualized target based on age and comorbidities. National estimates are reported by using weights that account for the complex sampling design of the NHANES.The percentage of people with diabetes and HbA1c <7.0% slightly declined from 52.2% (95% CI 48.7-55.7%) to 50.9% (95% CI 47.2-54.7%) between the two most recent waves of data. Achievement of individualized targets declined from 69.8% (95% CI 66.5-73.0%) to 63.8% (95% CI 60.1-67.5%). The percentage with HbA1c >9.0% increased from 12.6% (95% CI 10.5-14.8%) to 15.5% (95% CI 12.9-18.2%). Achievement of individualized targets varied by age group and presence of comorbidities, but exhibited similar trends as general target achievement.Despite the development of many new medications to treat diabetes during the past decade, the proportion of patients achieving glycemic control targets has not improved.Intarcia Therapeutics.
Project description:AIMS:To identify factors associated with achievement of glycated haemoglobin A1c (HbA1c) target at 24 weeks after commencing basal insulin therapy in individuals with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS:Post-hoc pooled analysis of 16 randomized, treat-to-target trials involving individuals with T2DM inadequately controlled with oral anti-hyperglycaemic drugs (n = 3415) initiated on once-daily insulin glargine 100 U/mL (Gla-100). Clinical outcomes were assessed by HbA1c response at 24 weeks and individuals were classified as "good responders" with HbA1c <7.0% (<53 mmol/mol) or as "poor responders" with HbA1c ≥7.0% (≥53 mmol/mol). Univariable and multivariable stepwise logistic regression analyses were performed to identify predictive factors for attaining HbA1c <7.0%. RESULTS:Lower levels of baseline HbA1c, fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG), higher body mass index (BMI), shorter diabetes duration and male sex were associated with a good glycaemic response, but not age or baseline C-peptide levels. Gla-100 dose (U/kg) was highest in the poor-responder group, which had the fewest hypoglycaemia episodes. Univariable analysis for achievement of HbA1c <7.0% confirmed these observations. Multivariable analysis retained baseline HbA1c, body weight, BMI, sex, 2-hours PPG and diabetes duration as predictors of a good response. Continued use of sulfonylureas, hypoglycaemia and change in body weight were indicative of poor response. CONCLUSIONS:Baseline HbA1c was the strongest determinant for achieving target HbA1c <7.0% by supplementary Gla-100 therapy, while sex and BMI were also useful indicators. However, age and C-peptide levels at baseline did not predict glycaemic response to the introduction of basal insulin.
Project description:INTRODUCTION:Treatment guidelines recommend a stepwise approach to glycemia management in patients with type 2 diabetes (T2D), but this may result in uncontrolled glycated hemoglobin A1c (HbA1c) between steps. This retrospective analysis compared clinical and economic outcomes among patients with uncontrolled T2D initiating two oral antidiabetes drugs (OADs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or basal insulin in a real-world setting. METHODS:Adults with T2D on OAD monotherapy were identified in the MarketScan claims database (2007-2014). Those initiating two OADs (simultaneously or sequentially), GLP-1 RAs, or basal insulin were selected (date of initiation was termed the 'index date'); patients were required to have HbA1c?>?7.0% in the 6 months pre-index date. HbA1c was compared from 6 months pre- to 1-year post-index. Annual all-cause healthcare utilization and costs were reported over the 1-year follow-up period. RESULTS:Data for 6054 patients were analyzed (2-OAD, n?=?4442; GLP-1 RA, n?=?361; basal insulin, n?=?1251). Baseline HbA1c was high in all cohorts, but highest in the basal-insulin cohort. Treatment initiation resulted in reductions in HbA1c in all cohorts, which was generally maintained throughout the follow-up period. Average HbA1c reductions from the 6 months pre- to 1 year post-index date were -1.2% for GLP-1 RA, -1.6% for OADs, and -1.8% for basal insulin. HbA1c?<?7.0% at 1 year occurred in 32.6%, 47.5%, and 41.1% of patients, respectively. Annual healthcare costs (mean [SD]) were lowest for OAD (US$10,074 [$22,276]) followed by GLP-1 RA (US$14,052 [$23,829]) and basal insulin (US$18,813 [$37,332]). CONCLUSION:Despite robust HbA1c lowering following treatment initiation, many patients did not achieve HbA1c?<?7.0%. Basal insulin, generally prescribed for patients with high baseline HbA1c, was associated with a large reduction in HbA1c and with higher costs. Therapy intensification at an appropriate time could lead to clinical and economic benefits and should be investigated further. FUNDING:Sanofi U.S., Inc.
Project description:BACKGROUND:Achievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia. OBJECTIVE:To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes. DESIGN:Parallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328). SETTING:Diabetes clinics in India and Pakistan. PATIENTS:1146 patients (575 in the intervention group and 571 in the usual care group) with type 2 diabetes and poor cardiometabolic profiles (glycated hemoglobin [HbA1c] level ?8% plus systolic blood pressure [BP] ?140 mm Hg and/or low-density lipoprotein cholesterol [LDLc] level ?130 mg/dL). INTERVENTION:Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records. MEASUREMENTS:Proportions achieving HbA1c level less than 7% plus BP less than 130/80 mm Hg and/or LDLc level less than 100 mg/dL (primary outcome); mean risk factor reductions, health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes). RESULTS:Baseline characteristics were similar between groups. Median diabetes duration was 7.0 years; 6.8% and 39.4% of participants had preexisting cardiovascular and microvascular disease, respectively; mean HbA1c level was 9.9%; mean BP was 143.3/81.7 mm Hg; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months, a greater percentage of intervention participants achieved the primary outcome (18.2% vs. 8.1%; relative risk, 2.24 [95% CI, 1.71 to 2.92]). Compared with usual care, intervention participants achieved larger reductions in HbA1c level (-0.50% [CI, -0.69% to -0.32%]), systolic BP (-4.04 mm Hg [CI, -5.85 to -2.22 mm Hg]), diastolic BP (-2.03 mm Hg [CI, -3.00 to -1.05 mm Hg]), and LDLc level (-7.86 mg/dL [CI, -10.90 to -4.81 mg/dL]) and reported higher HRQL and treatment satisfaction. LIMITATION:Findings were confined to urban specialist diabetes clinics. CONCLUSION:Multicomponent QI improves achievement of diabetes care goals, even in resource-challenged clinics. PRIMARY FUNDING SOURCE:National Heart, Lung, and Blood Institute and UnitedHealth Group.