Real-world impact of glycated hemoglobin reduction on treatment intensification and glycated hemoglobin goal attainment in type 2 diabetes mellitus patients initiated on a sodium glucose co-transporter 2 (SGLT2) inhibitor (SGLT2i)

Objective: To evaluate the impact of a 0.2% reduction in glycated hemoglobin (HbA1c) on treatment intensification, poor HbA1c control and HbA1c goal attainment in patients with type 2 diabetes mellitus (T2DM) initiated on a sodium glucose co-transporter 2 (SGLT2) inhibitor (SGLT2i).

Methods: IQVIATM Health Plan Claims Data – US and IQVIATM Ambulatory EMR Data – US databases (29 October 2012–31 March 2016) were used to identify adults with T2DM initiated on an SGLT2i (index date) who had HbA1c measurements pre- and post-index, and ≥6?months of eligibility pre-index (baseline). HbA1c change was defined as the difference between the first post-index and the last pre-index measurements. Cox regression models were used to assess treatment intensification, poor HbA1c control (i.e. HbA1c?>?9%, among patients <9% at baseline) and goal attainment (HbA1c?<?7%, <8%; among patients with HbA1c above goal at baseline) adjusting for HbA1c change and baseline characteristics. Patients were observed up to one year after the first HbA1c measurement or end of eligibility. Hazard ratios (HRs) and 95% confidence intervals (CIs) were reported.

Results: A total of 938 patients (mean age 54.9, 42.5% female, mean HbA1c 8.5%) were selected. Following SGLT2i initiation, each 0.2% reduction in HbA1c levels was associated with a decreased risk of treatment intensification (HR [95% CI]?=?0.90 [0.86–0.92]), a decreased likelihood of reaching HbA1c?>?9% (HR [95% CI]?=?0.85 [0.79–0.88]) and higher likelihoods of achieving a treatment goal of HbA1c?<?7% (HR [95% CI]?=?1.17 [1.12–1.21]) and HbA1c?<?8% (HR [95% CI]?=?1.08 [1.04–1.10]).

Conclusions: In T2DM patients, each HbA1c reduction of 0.2% following the initiation of an SGLT2i was associated with a significant positive impact on treatment intensification and HbA1c goal attainment.     

Consequences of delaying treatment intensification in type 2 diabetes: evidence from a UK database

Objective: Type 2 diabetes mellitus (TD2M) treatment focuses on achieving glycemic control, with HbA1c targeted at 6.5–7.5%. Clinicians commonly delay treatment intensification despite patients failing glycemic targets. This study evaluated longitudinal clinical and cost outcomes in patients failing metformin monotherapy using electronic medical records. Research design and methods: Adults with incident T2DM were identified in the UK Clinical Practice Research Datalink (CPRD) from 1 January 2000 to 31 March 2014. Patients were initiated on metformin monotherapy but had not reached target (HbA1c <7%). Patients were grouped by time to intensification of second-line therapy from first recorded HbA1c ≥7%: Group A, rapid intensification within 365 days; Group B, delayed intensification days 366–1824; Group C, never intensified. Patients were followed from day 366 for 5 years until end of study, switch to insulin, migration or death. Main outcome measures: The study evaluated baseline clinical and medication characteristics which were re-evaluated each year, including HbA1c, weight, cholesterol and concomitant prescribing. Results: A total of 6710 patients were included (Group A 2647, Group B 2452, Group C 1611). Group A achieved a significant decline in HbA1c at 1 year post-index date compared to Groups B and C (?1.13% Group A; +0.26% Group B, +0.16% Group C). A significantly higher proportion of patients achieved HbA1c target?<?7% in Group A (Group A [45.8%]; Group B [19.1%], p?<?0.0001). Using an adjusted hazard model, Group A was found to achieve the HbA1c target from the index date significantly faster than Group B (hazard ratio 3.25 [95% CI 2.87–3.69]). The most commonly prescribed second-line medications were sulfonylureas in Groups A and B throughout observation and were associated with significant weight gain (+1.3?kg per patient) in the adjusted models. Conclusions: Patients who were rapidly intensified achieved a maintained reduction in HbA1c faster than those with delayed intensification or no second-line therapy, despite a higher baseline HbA1c.     

Real-world evaluation of glycemic control among patients with type 2 diabetes mellitus treated with canagliflozin versus dipeptidyl peptidase-4 inhibitors

Objective To evaluate glycemic control among patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin (CANA) vs. dipeptidyl peptidase-4 (DPP-4) inhibitors.

Methods Using integrated claims and lab data from a US health plan of commercial and Medicare Advantage enrollees, this matched-control cohort study assessed adult T2DM patients receiving treatment with CANA or DPP-4 inhibitors (1 April 2013–31 December 2013). Cohorts were chosen hierarchically; the first pharmacy claim for CANA was identified as the index date; then the first pharmacy claim for a DPP-4 inhibitor was identified and index date set. Eligible patients had 6 months of continuous health plan enrollment before the index date (baseline) and 9 months after (follow-up) and no evidence of index drug in baseline. Patients were matched 1:1 using propensity score matching. Changes in glycated hemoglobin (HbA1c) and percentages of patients with HbA1c <8% and <7% during the follow-up were evaluated.

Results The matched CANA and DPP-4 inhibitor cohorts (53.2% treated with sitagliptin) included 2766 patients each (mean age: 55.7 years). Among patients with baseline and follow-up HbA1c results, mean baseline HbA1c values were similar, 8.62% and 8.57% (p?=?0.615) for the CANA (n?=?729) and DPP-4 inhibitor (n?=?710) cohorts, respectively. Change in HbA1c was greater among patients in the CANA cohort than for those in the DPP-4 inhibitor cohort (?0.92% vs. ?0.63%, p?<?0.001), and also among the subset of patients with baseline HbA1c ≥7% (-1.07% [n?=?624] vs. ?0.79% [n?=?603], p?=?0.004). During follow-up, greater percentages of the CANA cohort relative to the DPP-4 inhibitor cohort achieved HbA1c of <8% (66.0% vs. 58.6%, p?=?0.004) and <7% (35.4% vs. 29.9%, p?=?0.022).

Limitations This study was observational and residual confounding remains a possibility.

Conclusions In this real-world study of patients with T2DM, CANA use was associated with greater HbA1c reduction and higher percentages of patients attaining HbA1c goals than those treated with DPP-4 inhibitors.     

Glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes:real-world evidence from a Mediterranean area

Aims: To assess clinical characteristics and factors associated with glycated hemoglobin (HbA1c) reduction in type 2 diabetes (T2DM) patients initiating glucagon-like peptide-1 receptor agonists (GLP-1RAs).

Methods: Retrospective cohort study in patients with T2DM who initiated GLP-1RAs between 2007 and 2014 in primary health care centers in Catalonia (Spain). We evaluated changes in HbA1c and body weight at 6–12?months, and factors independently associated with achieving ≥1% HbA1c target reduction.

Results: Overall, 4242 patients (47.9% male; mean BMI 37.5?kg/m²) initiated a GLP-1RA. At 6–12?months, the mean HbA1c level decreased from the baseline 8.8% to 7.7% (?1.0%; SD?=?1.6). A 1% reduction in HbA1c was observed in 47.2% of patients. Patients lost a mean of 3.6?kg (SD?=?6.2). Sixty percent of patients reduced both HbA1c and body weight, and 17% achieved only one of these targets. Independent determinants of a 1% HbA1c reduction were baseline HbA1c, age, diabetes duration and being on insulin treatment. Reduction in weight or HbA1c and the proportion of patients achieving a HbA1c reduction of ≥1% was significantly larger among subjects prescribed liraglutide than exenatide and lixisenatide.

Conclusions: In this real-world, retrospective study, the magnitude of HbA1c and body weight reductions after addition of a GLP-1RA were similar to those observed in randomized controlled trials. Approximately 60% of patients attained reductions in both HbA1c and body weight, and there were significant differences among different drugs from this therapeutic group.     

Association between hypoglycemia risk and hemoglobin A1C in patients with type 2 diabetes mellitus

Objective: To better manage type 2 diabetes mellitus (T2DM), the tradeoff between improved glycemic control and hypoglycemia should be evaluated. The purpose of this study was to assess the relationship between hypoglycemia and hemoglobin A1c (HbA1c) in a real-world population.

Research design and methods: Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) was a multi-center, observational study. Patients ≥30 years old using any oral anti-hyperglycemic agent were recruited from seven European and five Asian countries between 2006 and 2007. Hypoglycemia events were collected through patient-reported questionnaires. HbA1c data was collected through chart review. Logistic regression was performed to assess the relationship between hypoglycemia and the most proximate HbA1c levels adjusting for potential confounders (demographics, clinical variables, other medication use, and comorbid conditions).

Results: A total of 4399 patients were recruited and analyzed. Mean age was 60 years, 52% were male, and 75% were on sulfonylureas (S.U.s). Respectively, 37% or 42% of patients reported hypoglycemia in the past 6 (Asia) or 12 months (Europe) before recruitment. Prevalence of hypoglycemia increased significantly (33% to 40%) as HbA1c decreased (p?=?0.035). The same trend was also observed among S.U.-treated patients (p?<?0.01). After adjusting for confounders, hypoglycemia prevalence was significantly higher for HbA1c <7.0% (odds ratio [O.R.]?=?1.66 [95% C.I. 1.21, 2.28]; p?=?0.002) vs. HbA1c ≥10.0%.

Limitations: Our analyses pooled data from Asia and Europe, which differed in terms of the recall period for ascertaining hypoglycemia symptoms and the timing of latest HbA1c measure.

Conclusions: Lower HbA1c level was associated with higher hypoglycemia prevalence among S.U.-treated patients. HbA1c level should be taken into consideration when reporting hypoglycemia prevalence.     

Patterns and trends in insulin initiation and intensification among patients with type 2 diabetes mellitus in the Western Pacific region

Objective: Current and future estimates of the burden of diabetes for the Western Pacific (WP) region are among the highest in the world. Verifying Insulin Strategy and Initial Health Outcome Analysis (VISION) was an 18 month observational study that explored treatment approaches in patients with type 2 diabetes mellitus (T2DM) initiating insulin in the WP region.

Methods: A total of 1065 patients aged ≥18 years with T2DM initiating insulin therapy in normal clinical course were enrolled from Hong Kong, Malaysia, Philippines, Taiwan and Thailand. Participants’ data was recorded by the treating physicians. Patient-reported outcomes (PROs) were assessed using questionnaires completed by participants.

Results: The mean age of patients was 57.2 years with mean glycosylated hemoglobin (HbA1c) of 10.0%. About 66% of patients had an HbA1c ≥9.0% at insulin initiation despite 74% of them being on two or more oral antidiabetic agents at the time of insulin initiation. Basal insulin was initiated in 72% and premixed insulin in 27% of patients. Changes in insulin therapy was observed in 63% of patients and, by the end of study, 28% achieved HbA1c levels of <7.5%. The proportion of patients completely satisfied with their insulin treatment increased over the study course and the quality of life (QoL) score increased from baseline to the study end.

Conclusion: As high HbA1C levels indicate a delayed start of insulin therapy, timely initiation and early intensification of insulin therapy is necessary in the region to achieve adequate glycemic control in time and prevent diabetes complications. Data from PROs suggests that the insulin treatment improves QoL in most patients.     

Efficacy of hypoglycemic treatment in type 2 diabetes stratified by age or diagnosed age: a meta-analysis

Aim: To compare the effects of blood glucose lowering regimens in groups of patients categorized by baseline age and diagnosed age.

Methods: Placebo-controlled randomized trials in type 2 diabetes patients with a study length ≥12 weeks were included.

Results: A total of 246 trials were included. HbA1c changes from baseline corrected by placebo were comparable in sulfonylurea treatment between older and younger patients’ groups (weighted mean difference (WMD), –1.28% vs –0.92%, p > 0.05). Treatment with metformin between groups resulted in a comparable change in HbA1c levels (WMD, –0.97% vs –1.23%, p > 0.05). Treatment with α–glucosidase inhibitor (WMD, –0.68% vs –0.67%, p > 0.05), treatment with thiazolidinedione (WMD, –0.74% vs –1.01%, p > 0.05), treatment with DPP-4 inhibitors (WMD, –0.67% vs –0.67%, p > 0.05), and treatment with SGLT2 inhibitors (WMD, –0.54% vs –0.67%, p > 0.05) between groups also resulted in comparable HbA1c changes. Treatment with GLP-1 analogs between groups in HbA1c changes were also comparable (p > 0.05). Regression analysis indicated that the baseline age or diagnosed age was not associated with the HbA1c changes from baseline.

Conclusion: In each hypoglycemic treatment, the baseline age or diagnosed age was not associated with the HbA1c changes from baseline.     

First-line disease-modifying drugs in relapsing–remitting multiple sclerosis: an Italian real-life multicenter study on persistence

Objective: The introduction of oral disease-modifying drugs (DMDs) in addition to the available, injectable, ones for relapsing–remitting multiple sclerosis (RRMS) could be expected to improve medication persistence due to a greater acceptability of the route of administration. The aim of the study was to compare the proportion of patients discontinuing injectable DMDs (interferon beta 1a/1b, pegylated interferon, glatiramer acetate) with those discontinuing oral DMDs (dimethylfumarate and teriflunomide) during an observation period of at least 12 months. Secondary aims were to compare the time to discontinuation and the reasons for discontinuation between the two groups and to explore the demographic and clinical factors associated with DMD discontinuation.

Methods: In this prospective, multi-center, real-life observational study, patients commencing any first-line DMD between 1 January 2015 and 31 July 2016 were enrolled and followed up for at least 12 months or until the drug was discontinued.

Results: Of the 520 included patients, 262 (49.6%) started an injectable and 258 (50.4%) an oral DMD. There was no difference in the proportion of patients on oral (n?=?62, 24%) or on injectable (n?=?60, 23%) DMDs discontinuing treatment, the most frequent reason being adverse events/side-effects. Higher baseline Expanded Disability Status Scale (EDSS) scores and younger age increased the odds of treatment withdrawal. Time to treatment discontinuation was not different between the two groups and was not influenced by the initiated DMD (oral versus injectable), even after adjustment for baseline differences.

Conclusion: The route of administration alone (i.e. oral versus injectable) was not a significant predictor of persistence with first-line DMDs in RRMS.     

Safety and effectiveness of ipragliflozin in elderly versus non-elderly Japanese type 2 diabetes mellitus patients: 12 month interim results of the STELLA-LONG TERM study

Objective: STELLA-LONG TERM is an ongoing post-marketing surveillance study examining the safety and effectiveness of ipragliflozin in real-world clinical practice in Japan. This interim report of STELLA-LONG TERM examined the safety and effectiveness of ipragliflozin in non-elderly and elderly Japanese patients with type 2 diabetes mellitus (T2DM) using data up to 12 months.

Methods: Data from T2DM patients who were first prescribed ipragliflozin between July 2014 and October 2015 and whose 12 month data were locked by January 2018 were analyzed and compared between non-elderly (<65 years) and elderly patients (≥65 years).

Results: The safety and efficacy analysis sets included 11,051 and 8788 patients, respectively. Elderly patients accounted for 28.6% (n?=?3157) of the study population. The mean body mass index was 29.9?kg/m² and 26.8?kg/m², the percentage of patients with glycated hemoglobin (HbA1c) <8.0% was 50.1% and 59.5%, and the percentage of patients with complications was 83.2% and 87.3% in the non-elderly and elderly groups, respectively. Mean HbA1c and body weight decreased significantly from baseline to 12 months in both age groups, regardless of baseline HbA1c and body weight (all p?<?.05). The incidence of adverse drug reactions (ADRs) was 14.8% and 14.2% and that of serious ADRs was 0.8% and 1.4% in non-elderly and elderly patients, respectively (p?=?.002 for serious ADRs).

Conclusion: The incidence of serious ADRs was higher in elderly patients than non-elderly patients. Ipragliflozin was effective in both non-elderly and elderly patients with T2DM in the real-world clinical setting.     

Transitioning from oral risperidone or paliperidone to once-monthly paliperidone palmitate: a real-world analysis among Veterans Health Administration patients with schizophrenia who have had at least one prior hospitalization

Abstract

Objective: To address gaps in the literature on healthcare resource utilization (HRU) and costs among patients with schizophrenia and prior hospitalization who transition from oral risperidone or paliperidone (oral ris/pali) to once-monthly paliperidone palmitate (PP1M) in a real-world setting by comparing treatment patterns, HRU, and costs 12-months pre- and post-transition to PP1M among Veterans Health Administration (VHA) patients affected by schizophrenia who have had ≥1 hospitalization.

Methods: VHA patients with schizophrenia (aged ≥18?years) who initiated oral ris/pali, had ≥1 all-cause inpatient stay, and transitioned to PP1M from January 2015–March 2017 were included from the VHA database. The first transition date to PP1M was identified as the index date. Patients were required to have continuous health plan eligibility for 12?months pre- and post-PP1M. Outcomes were compared using the Wilcoxon signed-rank and McNemar’s test, as appropriate.

Results: The study included 319 patients (mean [SD] age?=?51.6 [4.2] years) during 12 months of baseline and follow-up. During pre-PP1M transition, 7.2% of the patients were adherent (proportion of days covered [PDC]?≥?80%) to oral ris/pali. Post-PP1M transition, 27.6% of the patients were adherent to PP1M. Comparison of HRU outcomes from the pre- to post-PP1M transition revealed significantly lower all-cause inpatient stays (3.5 vs 1.4, p?<?.0001) and shorter inpatient length of stay (43.4 vs 18.3?days, p?<?.0001). Similar trends were seen for mental health and schizophrenia-related HRU. Cost outcome comparison indicated significantly lower all-cause inpatient costs ($64,702 vs $24,147, p?<?.0001), total medical costs ($87,917 vs $56,947, p?<?.0001), and total costs ($91,181 vs $69,106, p?<?.0001). A similar trend was observed for mental health and schizophrenia-related costs.

Conclusions: Transitioning from oral ris/pali to PP1M may significantly improve HRU and provide potential cost savings in VHA patients with schizophrenia and ≥1 prior hospitalization.     

Treatment preference for weekly versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: outcomes from the TRINITY trial

Abstract

Objective: To examine patient preference for treatment with the oral once-weekly dipeptidyl peptidase-4 inhibitor (DPP-4i), trelagliptin, and oral once-daily DPP-4i, alogliptin, administered for 8?weeks each in patients with type 2 diabetes mellitus prescribed a daily DPP-4i.

Methods: In this randomized, open-label, two-way crossover study, patients received trelagliptin followed by alogliptin (T-A group) or alogliptin followed by trelagliptin (A-T group), for 8?weeks each (NCT03231709, JapicCTI-173662). Treatment preference was assessed using a standardized questionnaire in the overall population and by baseline characteristics. Other outcomes included patient satisfaction with diabetes treatment (assessed using the Diabetes Treatment Satisfaction Questionnaire [DTSQ]), hemoglobin A1c (HbA1c) levels after 8?weeks of treatment with each agent, and safety.

Results: Sixty patients from two clinical sites were randomized 1:1 to T-A and A-T groups (each n?=?30); baseline characteristics were similar between groups. After 16?weeks of treatment, 51.7% of patients preferred treatment with alogliptin compared with 30.0% selecting trelagliptin (p?=?.014); preference for alogliptin was consistently greater than for trelagliptin in the secondary analyses by baseline characteristics. DTSQ score and HbA1c levels were similar between treatments after 8?weeks of therapy. Both treatments demonstrated favorable safety and tolerability profiles.

Conclusions: Patients expressed a significantly greater treatment preference for once-daily alogliptin than once-weekly trelagliptin, although patient satisfaction and HbA1c levels were similar across treatments. The decision to administer a once-weekly or once-daily DPP-4i is likely to depend on patient preference, patient-physician discussions, and treatment practices of the prescribing physician.

Trial registration: ClinicalTrials.gov identifier: NCT03231709.     

A randomized,double-blind,non-inferiority trial evaluating the efficacy and safety of omarigliptin,a once-weekly DPP-4 inhibitor,or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy

Objective: To evaluate the efficacy and safety of adding the once-weekly DPP-4 inhibitor omarigliptin or the sulfonylurea glimepiride to the treatment regimen of patients with type 2 diabetes (T2DM) and inadequate glycemic control on metformin monotherapy.

Methods: Patients with T2DM and HbA1c ≥6.5% to ≤9.0% while on a stable dose of metformin (≥1500?mg/day) were randomized to omarigliptin 25?mg once-weekly (n?=?376) or glimepiride up to 6?mg once daily (n?=?375) for 54 weeks. The primary hypothesis was that omarigliptin is non-inferior to glimepiride in reducing HbA1c at week 54.

Results: The mean baseline HbA1c was 7.5% in the omarigliptin group and 7.4% in the glimepiride group. After 54 weeks, the least squares (LS) mean change from baseline in HbA1c was –0.30% in the omarigliptin group and –0.48% in the glimepiride group, with a between-group difference (95% CI) of 0.18% (0.06, 0.30), which met the pre-specified criterion for declaring non-inferiority. The incidence of symptomatic hypoglycemia was 5.3% in the omarigliptin group and 26.7% in the glimepiride group. With the exception of hypoglycemia, the incidences of adverse events and discontinuations were similar between treatment groups. Relative to baseline, omarigliptin was associated with a mean weight loss (?0.4?kg) and glimepiride a mean weight gain (+1.5?kg).

Conclusions: After 54 weeks, as add-on therapy to metformin, once-weekly omarigliptin was generally well tolerated and non-inferior to glimepiride in improving glycemic control, with a lower incidence of hypoglycemia and with weight loss vs weight gain.     

The selection of healthy volunteers for clinical investigation: the case for volunteer pools

SUMMARY

Objective: To compare the metabolic effects of rosiglitazone, an antidiabetic agent of the thiazolidinedione class, in patients with type 2 diabetes with fair to moderate glycaemic control (glycosylated haemoglobin (HbA1c)?<?9%) and poor glycaemic control (HbA1c?>?9%).

Research design and methods: Data were pooled from two 26-week, randomised, placebo-controlled, double-blind studies of rosiglitazone (4 and 8?mg/day).

Results: After 26 weeks of treatment, HbA1c was significantly reduced (p?<?0.05) compared with baseline and placebo in patients taking rosiglitazone 8mg/day for both HbA1c stratifications, with greater reductions in patients with baseline HbA1c >9%. After 26 weeks of treatment, reductions in fasting plasma glucose (FPG) were significant (p?<?0.05) compared with baseline and placebo in both rosiglitazone treatment groups for both HbA1c stratifications, with greater reductions in the group with poor glycaemic control. Rosiglitazone significantly improved insulin sensitivity (p?<?0.05) compared with baseline in patients with baseline HbA1c <9%. Rosiglitazone significantly improved beta-cell function (p?<?0.05) compared with baseline with more improvement in the group with baseline HbA1c >9%. These improvements were statistically significant compared with placebo, regardless of HbA1c stratification.

Conclusion: Rosiglitazone significantly improved HbA1c and FPG levels in patients with type 2 diabetes, with the greatest improvements observed in patients with baseline HbA1c levels >9%.     

Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics

Objective: This study explores relevant outcomes with flexibly dosed paliperidone extended-release (ER) in a real-world design.

Research design and methods: Patients were recruited from 23 countries. Adults with non-acute schizophrenia (n = 1812), previously unsuccessfully treated with other oral antipsychotics, were transitioned to paliperidone ER and prospectively treated for 6 months.

Main outcome measures: Primary efficacy outcome for patients switching for the main reason of lack of efficacy was ≥ 20% improvement in Positive and Negative Syndrome Scale (PANSS) total scores. For patients switching for main reasons other than lack of efficacy, primary outcome was non-inferiority in efficacy compared with the previous medication.

Results: Among the lack-of-efficacy group, 61% achieved a ≥ 20% improvement in PANSS total scores from baseline to endpoint. For switchers from other than the lack-of-efficacy group, efficacy maintenance after switching to paliperidone ER was confirmed. Clinically relevant and statistically significant symptomatic improvements occurred for each patient group based on main reason for switching.

Conclusion: Paliperidone ER was well tolerated and associated with a meaningful clinical response in patients who switched from other oral antipsychotics, with insomnia and anxiety as most frequent side-effects.     

Factors that influence the efficacy of acarbose and metformin as initial therapy in Chinese patients with newly diagnosed type 2 diabetes: a subanalysis of the MARCH trial

Objective To conduct a subanalysis of the randomized MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycemic treatment) trial to investigate whether specific characteristics are associated with the efficacy of either acarbose or metformin as initial therapy.

Research design and methods A total of 657 type 2 diabetes patients who were randomly assigned to 48 weeks of therapy with either acarbose or metformin in the MARCH trial were divided into two groups based upon their hemoglobin A1c (HbA1c) levels at the end of follow-up: HbA1c?<7% (<53?mmol/mol) and ≥7% (≥53?mmol/mol). Univariate, multivariate, and stepwise linear regression analyses were applied to identify the factors associated with treatment efficacy.

Main outcome measures Because this was a subanalysis, no measurement was performed.

Results Univariate analysis showed that the efficacy of acarbose and metformin was influenced by HbA1c, fasting blood glucose (FBG), and 2 hour postprandial venous blood glucose (2hPPG) levels, as well as by changes in body mass index (BMI) (p?≤?0.006). Multivariate analysis and stepwise linear regression analyses indicated that lower baseline 2hPPG values and greater changes in BMI were factors that positively influenced efficacy in both treatment groups (p?≤?0.05). Stepwise regression model analysis also revealed that a lower baseline homeostasis model assessment-estimated insulin resistance (HOMA-IR) and higher serum insulin area under the curve (AUC) were factors positively influencing HbA1c normalization in all patients (p?≤?0.032).

Conclusions Newly diagnosed type 2 diabetes patients with lower baseline 2hPPG and HOMA-IR values are more likely to achieve glucose control with acarbose or metformin treatment. Furthermore, the change in BMI after acarbose or metformin treatment is also a factor influencing HbA1c normalization. A prospective study with a larger sample size is necessary to confirm our results as well as measure β cell function and examine the influence of the patients’ dietary habits.