Oral Antidiabetic Monotherapy Research Articles

Treatment patterns and satisfaction in patients with type 2 diabetes newly initiating oral monotherapy with antidiabetic drugs in Japan: results from the prospective Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND)

IntroductionTo present longitudinal data from the Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND) in Japan.Research design and methodsIn this multicenter, prospective, observational cohort study, patients with type 2...

RF28 | PSUN183 Intestinal microbiota composition in patients with type 2 diabetes and effects of 12 weeks of oral anti-diabetic treatment

Abstract Introduction The cause-effect relationships of dysbiosis and type 2 diabetes are complex and remain to be elucidated, very likely a two-way interaction. The aim of the study was to evaluate intestinal microbiota composition in patients with type 2 diabetes. Material and Methods This is a case-control study among patients with type 2 diabetes. Individuals were eligible if they were aged ≥18 years, were newly diagnosed with type 2 diabetes, had HbA1c levels ≥6.5 and ≤10.0%, and have been treated for oral antidiabetic agents for 3 months. The primary endpoint was the change from baseline in intestinal microbiota compositon after 12 weeks of treatment and comparison with healthy controls. Secondary endpoints were; change from baseline in intestinal microbiota composition after 12 weeks of oral antidiabetic monotherapy and comparison with healthy controls. A minimum of 5 mL fresh stool sample was collected at Day O of the study and 12 weeks later in a 15 mL Falcon tube and rapidly transferred to −80 °C to be stored in an upright position until DNA extraction. The V3 and V4 regions of the 16S rRNA gene were amplified following the 16S Metagenomic Sequencing Library Preparation. RESULTS: During the study period, 44 eligible patients were planned to enroll the study. Detailed analysis has been performed in 24 patients with type 2 diabetes (receiving oral antidiabetic treatment, metformin or linagliptin) and 10 age-matched healthy controls. The Chao-1 and Shannon Index were lower in the type 2 diabetes group before and after treatment groups (p<0.01 for both). PCoA plots were constructed to demonstrate separation of groups of samples for unweighted UniFrac distance, weighted UniFrac distance, and Bray–Curtis dissimilarity distance and no statistically significant differences between or within the type 2 diabetes and healthy control groups. At the first visit (before treatment), at phylum level, Bacteroidetes abundance have been observed in diabetic group, while Actinobacteria and Firmicutes in healthy controls. At genera level, we observed Gemmiger and Collinsella predominance in diabetes group; however, Faecalibacterium, Bacteroides and Alistipes in healthy controls. After 12 weeks of treatment, at genera level, Lactobacillus, Rothia and Collinsella increased in type 2 diabetes group however, microbiota composition was still different comparing the healthy controls. In patients receiving 12 weeks of metformin, Prevotella and Lactobacillus increased at genera level while Dialister and Ruminocococcus decreased. DISCUSSION: We report that there is a substantial change in the composition of the gut microbiota in patients with type 2 diabetes. We observed the beneficial effects as relative abundance of short chain fatty acid producing bacteria increased (eg, Prevotella, Lactobacillus) in metformin group. The interaction of the anti-diabetic drugs with gut microbiota have been less studied, further studies will highlight the clinical effect of these alteration in intestinal microbiota composition in diabetes. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m., Monday, June 13, 2022 12:37 p.m. - 12:42 p.m.

Clinical and demographic characteristics, management of patients with type 2 diabetes mellitus and vascular complications: analysis of the Ukrainian cohort of the DISCOVER Global Registry

The aim – to describe baseline data of the Ukraine cohort of DISCOVER Global Registry (DGR) with real-world insights on current treatment practices, complications, and associated clinical outcomes in people with type 2 diabetes mellitus (T2DM).Materials and methods. This healthcare provider-led prospective registry involves non‑interventional data collection from adults (aged ≥ 18 years) with T2DM receiving standard medical care as part of routine clinical practice per their treating physician’s discretion. Results and discussion. The initial data of 353 people with T2DM, who were included in the Ukrainian cohort of the DGR Register, were analyzed. The mean (±standard deviation) age of the study population was 58.85±10.02 years with female predominance (64 % [n=226]). The mean T2DM duration was 10.27±12.15 years with a mean glycated hemoglobin (HbA1c) level of 8.62±1.89 %. Only one-fifth (20.5 %, n=59) of the patients had glycemic control (HbA1c < 7.0 %). Among those with any complication, 73.8 % had microvascular and 79.3 % had cardiovascular complications. Retinopathy and heart failure were the most common microvascular and cardiovascular complications, respectively. Overall, 88 % of the patients were taking any antidiabetic therapy; of these, 27.3 % received insulin (monotherapy: n=28; combination therapy: n=57). As oral antidiabetic drugs (OAD), 32.2 % and 12.9 % received metformin and sulphonylurea monotherapies, respectively; minor proportions received newer OAD monotherapy (sodium-glucose co-transporter-2 inhibitors [4.8 %] and dipeptidyl peptidase-4 inhibitor [1 %]).Conclusions. Baseline data from the Ukraine cohort of DGR reveals poor glycemic control, with a higher mean HbA1c and proportion of patients with micro- and cardiovascular complications than that of the global cohort. The landscape of therapeutic agents displayed marked diversities in the management strategies. Robust real-world data from the DGR can help understand the gaps in care of T2DM patients and lights the need of the formulation of region-specific holistic therapeutic strategies to optimize glycemic control and improving clinical patients’ outcomes.

Insulin therapy: Associated challenges in Type 2 Diabetes

The study was to assess challenges associated with insulin therapy in people with type 2 diabetes and how these challenges can be resolved to increase patient safety and quality of life. Participants of both sexes between the ages of 20 and 59 years were enrolled across successive samples and assessed for the prevalence of type 2 diabetes, hypertension (whether hypertensive or not), dyslipidemia, and smoking status. Weight gain and hypoglycemia are the primary diagnostic and outcome criteria for type 2 diabetes when taking insulin therapy. According to the study, only 27.27% of type 2 diabetes patients were receiving oral antidiabetic drug monotherapy, while 72.72% were receiving antidiabetic drug combination therapy. Only 43.75% of the 72.72% of patients who received antidiabetic prescription combination medication received triple combination therapy, whereas 56.25% received dual combination therapy. It was concluded that participants undergoing conventional therapy are at a higher risk of hypoglycemia but a much lower risk of weight gain and other complications. Due to a lack of cultural understanding regarding these risk factors for weight gain and their modifiable risk factors, both individual and public health measures could be warranted.

Traditional and complementary medicine use in patients with type 2 diabetes: Findings from a multicenter cross-sectional questionnaire survey in Selangor, Malaysia

Current global estimates of traditional and complementary medicine (T&CM) utilization range from 9.8% to 76%, with high rates of use being documented in Japan, South Korea, and Malaysia. Previous research has shown that patients with diabetes are more likely to use T&CM than individuals without diabetes. A multicenter cross-sectional survey of patients with type 2 diabetes mellitus was conducted at five primary care health clinics in Petaling district of Selangor, Malaysia from June 1, 2020 through September 30, 2020. A total of 476 patients were enrolled. 58.0% of men and 64.8% of women reported to use at least a type of T&CM. The prevalence of T&CM use among Malays, Chinese, and Indians was 71.1%, 33.3%, and 62.9% respectively. The most commonly used T&CM were herbal remedies (45.2%), followed by nutritional supplements (9.9%). 80.0% of the patients would follow their doctor’s instruction if the doctor asked them not to use T&CM, whereas 70.2% would consult their doctor about using T&CM. Factors associated with higher tendency for T&CM use comprised increased age, unemployed, oral antidiabetic monotherapy, presence of family history of diabetes, and coexisting chronic disease. T&CM therapies were common among multi-ethnic patient population with type 2 diabetes. The high rate of use warranted clinical attention and intervention to reduce the risk of drug-associated adverse events.

Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan

IntroductionTo investigate factors affecting glycemic control, oral antidiabetic drug (OAD) treatment distribution and self-care activities among patients with type 2 diabetes mellitus (T2DM) who newly initiate OAD monotherapy in a...

Diabetes distress, happiness, and its associated factors among type 2 diabetes mellitus patients with different therapies.

This study aimed to investigate diabetes distress, happiness, and its associated factors of patients with type 2 diabetes mellitus (T2DM) treated by different therapies, and to analyze the related impact factors. A total of 1512 patients with T2DM were randomly selected from 18 tertiary hospitals in Hunan province from January 2016 to April 2016 who has been treated with oral antidiabetics monotherapy, insulin monotherapy, and combination therapy. Use the general information questionnaire, WHO-5 (the World Health Organization 5 well-being index) and PAID (the problem areas in diabetes scale) to collect the data. There are 846 (55.95%) patients that have serious emotional disorders, and the diabetes related distress in insulin treatment group was higher than that in combination treatment group (P < .05). Happiness of T2DM patients in combination therapy was higher than oral antidiabetic drug monotherapy and insulin monotherapy (P < .05). There was a negative correlation between diabetic suffering and happiness in patients with different treatments (R ranged from –0.335 to –0.436, P < .001). Age and happiness experience could explain 14.8% of the variance. Acute and chronic complications, controlled blood glucose level, lifestyle, therapies, and school education can explain 18.3% variance. Under different therapies, the suffering and happiness of T2DM patients differed from each other. The suffering and happiness of T2DM were related to different therapies, age, complications, glycaemic control, lifestyle, school education, and so on.

Comparison of healthcare resource utilization and costs in patients with type 2 diabetes initiating dapagliflozin versus sitagliptin

To compare healthcare costs and utilization in patients with type 2 diabetes (T2D) who initiated dapagliflozin (DAPA) with costs and utilization in those who initiated sitagliptin (SITA) in a real-world setting. This was a retrospective study of health plan enrollees in two US commercial claims databases or Medicare Part D. The study population comprised adult patients with T2D who initiated DAPA or SITA between January 1, 2014 and April 30, 2015. DAPA and SITA initiators were propensity-score-matched, and healthcare utilization and costs during the 1-year follow-up period were compared. Analyses were conducted separately for patients with evidence of oral antidiabetic drug (OAD) monotherapy use at baseline. A total of 2722 patients were included in each matched cohort. Follow-up unadjusted all-cause costs ($16 065 and $17 281; P = 0.135) and diabetes-related costs ($9697 and $9354; P = 0.539) were similar in the DAPA and SITA cohorts. Higher office and outpatient visit costs in the SITA group were offset by higher pharmacy costs in the DAPA group. In the subgroup of 1804 patients with OAD monotherapy use at baseline, patients in the SITA group had higher total all-cause costs compared with those in the DAPA group ($14 884 vs. $12 353; P = 0.026). Patients who initiated DAPA or SITA had similar all-cause and diabetes-related healthcare costs over 1 year of follow-up. In the subgroup of patients treated with OAD monotherapy at baseline (84% metformin monotherapy), those who initiated DAPA as add-on therapy had lower costs than patients who added SITA.

QUALITY OF LIFE ANALYSIS IN DIABETES MELLITUS TYPE 2 PATIENTS USING MONOTHERAPY AND COMBINATION TREATMENT OF MEDICINE

Treatment of diabetes mellitus (DM) can be vary, using monotherapy or combination therapy, and it depends on the severity of the disease. That variation will give influences to the patient’s clinical condition and also their quality of life (QoL). The objective of this study is to determine the average of QoL’s score in DM patients who use monotherapy and combination therapy of antidiabetic oral in Public Health Center of Kotagede 1 Yogyakarta. This study was conducted in a cross sectional study. Subjects were people who had an age above 18, got the diagnose of DM type 2, and also consumed of oral antidiabetic monotherapy or combination. The measurement of QoL is using a DQLCTQ questionnaire in Bahasa Indonesia. Analysis statistic with independent sample T-test was used to determine the differences between QoL in patients who use monotherapy and combination. Subjects who met the inclusion criteria are 52 patients. About 82.70% (43 patients) of the patients used combination and the other (9 patients) used monotherapy. The average of QoL in monotherapy patients (78.95±11.36) was higher than in combination therapy’s (75.18±10.57). Result of the analysis statistic showed that there is no significant differences (p0.095) of QoL between monotherapy and combination therapy patients.

Drug usage patterns and treatment costs in newly-diagnosed type 2 diabetes mellitus cases, 2007 vs 2012: findings from a large US healthcare claims database analysis

Objective To explore trends in demographics, comorbidities, anti-diabetic drug usage, and healthcare utilization costs in patients with newly-diagnosed type 2 diabetes mellitus (T2DM) using a large US claims database.Methods For the years 2007 and 2012, Truven Health Marketscan Research Databases were used to identify adults with newly-diagnosed T2DM and continuous 12-month enrollment with prescription benefits. Variables examined included patient demographics, comorbidities, inpatient utilization patterns, healthcare costs (inpatient and outpatient), drug costs, and diabetes drug claim patterns.Results Despite an increase in the overall database population between 2007–2012, the incidence of newly-diagnosed T2DM decreased from 1.1% (2007) to 0.65% (2012). Hyperlipidemia and hypertension were the most common comorbidities and increased in prevalence from 2007 to 2012. In 2007, 48.3% of newly-diagnosed T2DM patients had no claims for diabetes medications, compared with 36.2% of patients in 2012. The use of a single oral anti-diabetic drug (OAD) was the most common diabetes medication-related claim (46.2% of patients in 2007; 56.7% of patients in 2012). Among OAD monotherapy users, metformin was the most commonly used and increased from 2007 (74.7% of OAD monotherapy users) to 2012 (90.8%). Decreases were observed for sulfonylureas (14.1% to 6.2%) and thiazolidinediones (7.3% to 0.6%). Insulin, predominantly basal insulin, was used by 3.9% of patients in 2007 and 5.3% of patients in 2012. Mean total annual healthcare costs increased from $13,744 in 2007 to $15,175 in 2012, driven largely by outpatient services, although costs in all individual categories of healthcare services (inpatient and outpatient) increased. Conversely, total drug costs per patient were lower in 2012 compared with 2007.Conclusions Despite a drop in the rate of newly-diagnosed T2DM from 2007 to 2012 in the US, increased total medical costs and comorbidities per individual patient suggest that the clinical and economic trends for T2DM are not declining.

A Post Hoc Analysis of HbA1c, Hypoglycemia, and Weight Change Outcomes with Alogliptin vs Glipizide in Older Patients with Type 2 Diabetes.

IntroductionAdverse events and complications limit the long-term use of current antidiabetic treatment options for patients with type 2 diabetes mellitus (T2DM), particularly for older adults who are often receiving therapy for other comorbid conditions. The aim of this study was to evaluate the benefits of the dipeptidyl peptidase-4 inhibitor, alogliptin, versus glipizide, a sulfonylurea, in achieving glycemic control without the risk of hypoglycemia, weight gain, or both in older patients with T2DM.MethodsThis was an exploratory, post hoc analysis of a global, multicenter, randomized, double-blind, active-controlled study comparing alogliptin and glipizide. Patients (n = 441) aged 65–90 years with glycosylated hemoglobin (HbA1c) 6.5–9.0% who failed on diet and exercise alone or who had inadequately controlled T2DM despite oral antidiabetic monotherapy were recruited from 110 sites across 15 countries. Alogliptin 25 mg (n = 222) or glipizide 5 mg up-titrated to 10 mg (n = 219) was administered once daily for 52 weeks. Composite endpoints of HbA1c ≤7.0% coupled with the absence of hypoglycemia and weight gain, or an HbA1c reduction of ≥0.5% in the absence of hypoglycemia and weight gain, were then measured.ResultsIn the primary analysis, least squares mean HbA1c changes from baseline to Week 52 were similar in both the alogliptin and glipizide groups. The proportion of patients achieving HbA1c ≤7.0% without hypoglycemia or weight gain was significantly higher for alogliptin versus glipizide (24% vs 13%, p < 0.03). Patients with a baseline HbA1c of <8.0% receiving alogliptin were also more likely to achieve HbA1c ≤7.0% without hypoglycemia or weight gain than those receiving glipizide (29% vs 13%, p < 0.03).ConclusionAlogliptin demonstrated similar efficacy to glipizide in lowering HbA1c in older patients with T2DM, but with significantly more patients achieving an HbA1c ≤7.0% without hypoglycemia or an increase in body weight. These results particularly apply to patients with baseline HbA1c below 8.0%.FundingThe study was sponsored by Takeda Global Research & Development Center, Inc., Deerfield, IL, and Takeda Global Research and Development Centre Ltd., London, United Kingdom.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-014-0088-5) contains supplementary material, which is available to authorized users.

A Systematic Review and Network Meta-Analysis Assessing the Effectiveness and Tolerability of Gliptins and Sulfonylureas as Monotherapy in Patients with Type 2 Diabetes Mellitus If Metformin is not Considered Appropriate

A significant proportion of patients with type-2-diabetes mellitus (T2DM) are unable to take Metformin as recommended first-line therapy due to gastrointestinal intolerance or contraindications such as chronic kidney disease. In contrast to combination therapy no network meta-analysis (NMA) has been undertaken for oral anti-diabetic drugs (OAD) as monotherapy in this population - particularly with respect to gliptins and sulfonylureas as second-line options. The purpose of this study is to assess the comparative effectiveness and tolerability of gliptins versus sulfonylureas in terms of glycated hemoglobin (HbA1c), body weight and hypoglycemia. A systematic review was conducted searching bibliographic databases, reports of regulatory authorities and clinical trial registries through July 2012 to identify randomized controlled trials in adult T2DM patients receiving at least 12 weeks of OAD monotherapy or placebo. A Bayesian NMA was performed to yield mixed treatment comparisons. Consistency was examined by the node split method. A total of 62 studies enrolling 21,302 patients informed the entire network. Due to their improved model fit estimates from random effect models are reported to account for heterogeneity across the set of studies. After a mean follow-up of 32 weeks, the difference in mean HbA1c was 0.26,0. 95 credible interval (CrI0.95): [0.1; 0.42], in favour of sulfonylureas. However, gliptins induced weight loss (difference in means: -1.21 kg; CrI0.95: [-1.57; -0.84] ) and were associated with a considerably lower incidence of any hypoglycemia compared to sulfonylureas (odds ratio: 0.22; CrI0.95: [0.15; 0.31] ). All effect estimates were statistically significant and consistent in terms of combining direct and indirect evidence. This is the first network assessing OAD monotherapy that can readily be extended to emerging therapies. With regard to glycemic control gliptins were slightly inferior to sulfonylureas, whereas they positively affected body weight and risk of hypoglycemia, confirming their role in second-line monotherapy.

Self-monitoring of blood glucose: use, frequency drivers, and cost in Argentina.

Although test strips for self-monitoring of blood glucose (SMBG) represent around 50% of diabetes treatment cost in Argentina, little is known about their current use and relationship with different types of treatment. We therefore aimed to estimate the current use of test strips and identify the major use drivers and the percentage they represent of total prescription costs in 2 entities of the social security system (SSS) of Argentina. Observational retrospective study measuring test strip prescriptions delivered by pharmacies from the province of Buenos Aires (8115 records collected during 3 months provided by the Colegio de Farmacéuticos de la Provincia de Buenos Aires) of affiliates with type 2 diabetes (T2DM) from 2 large entities of the SSS system. The average monthly test strips/patient used for SMBG was 97.5 ± 70.1. This number varied according to treatment: monotherapy with oral antidiabetic drugs (OAD) < combined OAD therapy < insulin treatment. Test strips represented a higher percentage of the total prescription cost in people under OAD monotherapy (84.6%) and lower in those with insulin analogs (46.9%). In our population, the type of hyperglycemia treatment was the main driver of test strip use for SMBG and its impact on the total prescription cost depends on the kind of such treatment. Since it has been shown that patients' education and prescription audit can optimize test strip use and treatment outcomes, implementation of such strategies could appropriately support, optimize, and reduce ineffective test strip use in people with T2DM.

Monotherapy with the once weekly GLP-1 receptor agonist dulaglutide for 12 weeks in Japanese patients with type 2 diabetes: dose-dependent effects on glycaemic control in a randomised, double-blind, placebo-controlled study.

The aim of this study was to evaluate the dose-dependent effect of dulaglutide, a glucagon-like peptide-1 receptor agonist, on glycaemic control in Japanese patients with type 2 diabetes mellitus who were treated with diet/exercise or oral antidiabetic drug monotherapy. In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively). The primary measure was change from baseline in glycated haemoglobin (HbA1c; %) at 12 weeks. Continuous variables were analysed using a mixed-effects model for repeated measures. Significant dose-dependent reductions in HbA1c were observed (least squares mean difference versus placebo [95% confidence interval]): DU 0.25=-0.72% (-0.95, -0.48), DU 0.5=-0.97% (-1.20, -0.73), and DU 0.75=-1.17% (-1.41, -0.93); p<0.001. Significant improvements in plasma glucose (PG), both fasting and average 7-point self-monitored blood glucose, were also observed with dulaglutide versus placebo (p<0.001). Dulaglutide was well-tolerated. Gastrointestinal adverse events (AEs) were more common in dulaglutide-treated patients, with nausea the most frequent (8 [5.5%]). Few dulaglutide-treated patients discontinued due to AEs (4 [3.7%]), and no serious AEs related to study medication occurred. Three patients (DU 0.5=1 and DU 0.75=2) reported asymptomatic hypoglycaemia (PG ≤70 mg/dL). The observed dose-dependent reduction in HbA1c and acceptable safety profile support further clinical development of dulaglutide for treatment of type 2 diabetes mellitus in Japan.

Assessment of baseline characteristics, glycemic control and oral antidiabetic treatment in Asian patients with diabetes: The Registry for Assessing OAD Usage in Diabetes Management (REASON) Asia study (在亚洲糖尿病患者中评估基线特征、血糖控制情况以及口服降糖药物使用情况：使用登记表评估糖尿病治疗中口服药使用情况（REASON）的亚洲研究)

To assess baseline characteristics, glycemic control, and treatment with oral antidiabetic drugs (OAD) in type 2 diabetes mellitus (T2DM) patients. This multinational, observational study recruited patients ≥ 21 years of age who were newly diagnosed and/or treated with OAD monotherapy for <6 months but were inadequately controlled. In cross-sectional phase, data on demographics, medical history, diabetic complications and comorbidities, OAD treatment, glycosylated hemoglobin (HbA1c), and fasting blood glucose (FBG) were collected. In longitudinal phase evaluating 6-month follow-up of sulfonylurea (SU)-treated patients, additional data on reasons for not achieving HbA1c targets were collected. Of 1487 patients (mean [± SD] age 52.0 ± 11.6 years; 46.7% men; mean BMI 25.8 ± 4.4 kg/m(2) ) recruited, 75.9% were newly diagnosed, 73.3% had central obesity, 43.8% had hypertension, and 60.5% had dyslipidemia. The mean HbA1c was 9.8 ± 2.4%, and the mean FBG was 11.3 ± 4.3 mmol/L. At T0 (baseline) and T6 (month 6 visit), 99.8% (n=1066) and 97.1% (n=830) patients received SU, respectively. There was decrease from T0 to T6 in mean HbA1c (10.2% vs 7.3%, respectively; P<0.0001) and mean FBG (12.0 vs 7.6 mmol/L, respectively; P<0.0001). Number of patients with HbA1c <7% increased from T0 (4.5%) to T6 (46.8%). Reasons for not achieving target HbA1c included poor diabetes education (50.7%), non-compliance to OADs (21.4%), and fear of hypoglycemia (19.7%). Marked reductions in HbA1c and FBG are achievable in T2DM patients managed with OADs. However, patient education and compliance are important for achieving and maintaining treatment targets.

Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double‐blind, randomized, 1‐year study

To prospectively evaluate the efficacy and safety of alogliptin versus glipizide in elderly patients with type 2 diabetes mellitus (T2DM) over 1 year of treatment. This was a randomized, double-blind, active-controlled study of elderly T2DM patients (aged 65-90 years) with mild hyperglycaemia on diet/exercise therapy alone [glycosylated haemoglobin (HbA1c) 6.5-9.0%] or plus oral antidiabetic monotherapy (HbA1c 6.5-8.0%). Patients were randomized to once-daily alogliptin 25 mg or glipizide 5 mg titrated to 10 mg, if needed. Hypoglycaemic episodes were systematically captured under predefined criteria. In the primary analysis, HbA1c mean changes from a baseline of 7.5% were -0.14% with alogliptin (n = 222) and -0.09% with glipizide (n = 219) at the end of the study, demonstrating non-inferiority of alogliptin to glipizide [least squares (LS) mean difference = -0.05%; one-sided 97.5% confidence interval (CI): -∞, 0.13%]. More clinically relevant HbA1c reductions occurred among patients who completed the study: -0.42 and -0.33% with alogliptin and glipizide, with non-inferiority again confirmed (LS mean difference = -0.09%; one-sided 97.5% CI: -∞, 0.07%). Overall, alogliptin was safe and well tolerated, with notably fewer hypoglycaemic episodes than glipizide [5.4% (31 episodes) vs. 26.0% (232 episodes), respectively]; three patients experienced severe hypoglycaemia, all with glipizide. Alogliptin also resulted in favourable weight changes versus glipizide (-0.62 vs. 0.60 kg at week 52; p < 0.001). Alogliptin monotherapy maintained glycaemic control comparable to that of glipizide in elderly patients with T2DM over 1 year of treatment, with substantially lower risk of hypoglycaemia and without weight gain.

Adding Liraglutide to Oral Antidiabetic Drug Monotherapy: Efficacy and Weight Benefits

Aim: To examine the options for add-on therapy in patients with type 2 diabetes whose disease is no longer adequately controlled by lifestyle interventions and oral antidiabetic drug (OAD) monotherapy. Methods: This analysis included a subset of patients receiving prior OAD monotherapy from 2 phase 3, 26-week, randomized, double-blind, double-dummy, active-control, parallel-group, multicenter, multinational trials. Prior to randomization, patients not already receiving either metformin or glimepiride were switched to monotherapy with one of these drugs, and the dose was titrated to defined targets. Patients were then randomized to liraglutide (1.8 mg, 1.2 mg, or 0.6 mg once daily), placebo (OAD monotherapy plus placebo), or active comparator (rosiglitazone or glimepiride). For this analysis, only the liraglutide 1.8-mg dose was included. The primary outcome measure was change in glycosylated hemoglobin (HbA1c) from baseline. Secondary endpoints included in this analysis are percentage of patients achieving HbA1c < 7%, change in fasting plasma glucose, systolic blood pressure, body weight, β-cell function, hypoglycemic episodes, and nausea. Results: There was a significant reduction in HbA1c in patients previously treated with OAD monotherapy (P < 0.0001) and significantly more patients achieved HbA1c < 7% (P = 0.0005) with the addition of liraglutide than with rosiglitazone. In addition, rosiglitazone plus glimepiride was associated with significantly more weight gain (P < 0.0001) than liraglutide plus glimepiride (P = 0.04). For patients on metformin monotherapy, the addition of liraglutide or glimepiride resulted in similar levels of glycemic control; however, patients receiving glimepiride had significantly greater weight gain (P < 0.0001) and higher rates of minor hyperglycemia. Conclusion: Given the combination of effective glycemic control and weight benefits, liraglutide is a good option for early add-on therapy for patients on OAD monotherapy.

Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH): Study design and baseline characteristics

Rosiglitazone, a thiazolidinedione, has effects on insulin sensitivity and cardiovascular risk factors that may favorably impact the progression of coronary atherosclerosis. APPROACH is a double-blind randomized clinical trial comparing the effects of the insulin sensitizer rosiglitazone with the insulin secretagogue glipizide on the progression of coronary atherosclerosis. Patients with type 2 diabetes and coronary artery disease undergoing clinically indicated coronary angiography or percutaneous coronary intervention are randomized to receive rosiglitazone or glipizide for 18 months using a titration algorithm designed to provide comparable glycemic control between treatment groups. The primary end point is change in percent atheroma volume from baseline to study completion in a nonintervened coronary artery, as measured by intravascular ultrasound. Cardiovascular events are adjudicated by an end point committee. A total of 672 patients were randomized. The mean age was 61 years, hemoglobin A(1c) (HbA(1c)) 7.2%, body mass index 29.5 kg/m(2), and median duration of diabetes 4.8 years. At baseline, approximately half of the participants were receiving oral antidiabetic monotherapy (53.9%) with 27.5% receiving dual combination therapy and 17.9% treated with diet and exercise alone. Approximately two thirds of the participants (68%) had dyslipidemia, 79.9% hypertension, and 24% prior myocardial infarction. APPROACH has fully enrolled a high-risk patient population and will compare the glucose-independent effects of rosiglitazone and glipizide on the progression of coronary atherosclerosis, as well as provide additional data on the cardiovascular safety of rosiglitazone in patients with type 2 diabetes and coronary artery disease.

Liraglutide, a Once-daily Human GLP-1 Analog, In Type 2 Diabetes Provides Similar Glycemic Control with Reduced Body Weight Compared with Glimepiride when Added to Metformin.

This placebo-controlled (plb), double-blind, randomized 26-week trial investigated the effect on glycemic control (HbA1c) of three liraglutide doses (lira; 0.6, 1.2 or 1.8 mg sc, QD) added to metformin (met; 1 g BD) compared with met monotherapy (plb+met) or glimepiride (glim, 4 mg QD) added to met (glim+met). The trial included 1091 subjects with T2DM previously treated with oral antidiabetic drug (OAD) mono-therapy (35%) or combination therapy (65%), with mean±SD baseline HbA1c 8.4±1.0% and body weight (BW) 88.6±17.3 kg. HbA1c was significantly reduced in all lira groups vs plb+met. Reduction in HbA1c was greater in subjects previously treated with OAD mono vs combination therapy. The fraction of subjects achieving HbA1c<7.0% or <6.5% was significantly higher in lira+met vs plb+met, with no difference between lira+met vs glim+met. Change in fasting plasma glucose followed the same pattern as for HbA1c. BW decreased significantly in all lira groups vs glim+met. Reduction in BW was significantly greater in lira1.2+met and lira1.8+met vs plb+met. Presence of lira antibodies was 0-4% (only patients not entering the extension phase of the study were included: lira0.6, n=28; lira1.2, n=25; lira1.8, n=32). Minor hypoglycemia (<3.1 mmol/L) occurred in <4% of subjects in lira+met and plb+met, and in 16.9% in glim+met. There was no major hypoglycemia. The most common adverse events in lira+met were GI disorders (mainly nausea). Nausea initially occurred in 6-12% of subjects in lira+met, declining to plb+ met levels (2%) after 8–16 weeks' treatment. Liraglutide was well tolerated, produced a clinically significant reduction in HbA1c, and in contrast to met+glim resulted in few hypoglycemic episodes and weight loss in T2DM subjects. Tabled 1 Lira 0.6 mg + met Lira 1.2 mg + met Lira 1.8 mg + met Plc + met Glim + met Final HbA1c, % (SD) a No statistical analysis Change HbA1c, % (SE) 7.8 (1.1)−0.7 (0.1) * p<0.05 compared to plb+met 7.5 (1.1)−1.0 (0.1) * p<0.05 compared to plb+met 7.5 (1.2)−1.0 (0.1) * p<0.05 compared to plb+met 8.6 (1.4)+ 0.1 (0.1) 7.5 (1.1)−1.0 (0.1) Mono/combi changeHbA1c, % (SD) a No statistical analysis −0.8 (0.8)/−0.5 (1.1) −1.3 (1.2)/−0.6 (0.9) −1.3 (1.1)/−0.7 (1.1) −0.5 (1.3)/+ 0.5 (1.0) −1.1 (0.1)/−0.8 (1.0) % HbA1c <7.0% HbA1c <6.5 28.0 * p<0.05 compared to plb+met † p<0.05 compared to glim+met 11.3 * p<0.05 compared to plb+met † p<0.05 compared to glim+met , 35.3 * p<0.05 compared to plb+met 19.8 * p<0.05 compared to plb+met 42.4 * p<0.05 compared to plb+met 24.6 * p<0.05 compared to plb+met 10.84.2 36.322.2 Final FPG, mmol/L (SD) a No statistical analysis Change FPG, mmol/L (SE) 9.1 (2.6)−1.1 (0.2) * p<0.05 compared to plb+met 8.4 (2.6)−1.6 (0.2) * p<0.05 compared to plb+met 8.5 (2.3)−1.7 (0.2) * p<0.05 compared to plb+met 10.7 (57)+ 0.4 (0.2) 8.8 (2.4)−1.3 (0.2) Weight change, kg (SE) −1.8 (0.2) † p<0.05 compared to glim+met −2.6 (0.2) * p<0.05 compared to plb+met † p<0.05 compared to glim+met −2.8 (0.2) * p<0.05 compared to plb+met † p<0.05 compared to glim+met −1.5 (0.3) +1.0 (0.2) % minor hypos reported a No statistical analysis 3.3 0.8 2.5 2.5 16.9 * p<0.05 compared to plb+met † p<0.05 compared to glim+met a No statistical analysis Open table in a new tab

Self-Monitoring of Blood Glucose

Background: Although test strips for self-monitoring of blood glucose (SMBG) represent around 50% of diabetes treatment cost in Argentina, little is known about their current use and relationship with different types of treatment. We therefore aimed to estimate the current use of test strips and identify the major use drivers and the percentage they represent of total prescription costs in 2 entities of the social security system (SSS) of Argentina. Methods: Observational retrospective study measuring test strip prescriptions delivered by pharmacies from the province of Buenos Aires (8115 records collected during 3 months provided by the Colegio de Farmaceuticos de la Provincia de Buenos Aires) of affiliates with type 2 diabetes (T2DM) from 2 large entities of the SSS system. Results: The average monthly test strips/patient used for SMBG was 97.5 ± 70.1. This number varied according to treatment: monotherapy with oral antidiabetic drugs (OAD) < combined OAD therapy < insulin treatment. Test strips represented a higher percentage of the total prescription cost in people under OAD monotherapy (84.6%) and lower in those with insulin analogs (46.9%). Conclusions: In our population, the type of hyperglycemia treatment was the main driver of test strip use for SMBG and its impact on the total prescription cost depends on the kind of such treatment. Since it has been shown that patients’ education and prescription audit can optimize test strip use and treatment outcomes, implementation of such strategies could appropriately support, optimize, and reduce ineffective test strip use in people with T2DM.