Diabetes-Related Quality Measure Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials

December 16, 2014
Robert A. Bailey, MD

,
Ujjwala Vijapurkar, PhD

,
Gary E. Meininger, MD

,
Marcia F. T. Rupnow, PhD

,
Lawrence Blonde, MD

Supplements and Featured Publications, Diabetes-Related Quality Measure Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Anal, Volume 20, Issue 13 Suppl

Objective: To evaluate attainment of diabetes-related quality measures with canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg in patients with type 2 diabetes mellitus.

Study design: This post hoc analysis used pooled data from two 52-week, randomized, double-blind, phase 3 clinical trials that evaluated the comparative efficacy of canagliflozin and sitagliptin. One trial evaluated patients on metformin at baseline with add-on canagliflozin 100 mg, canagliflozin 300 mg, or sitagliptin 100 mg; the other trial evaluated patients on metformin and a sulfonylurea at baseline with add-on canagliflozin 300 mg or sitagliptin 100 mg.

Methods: Individual diabetes-related quality measures, including glycated hemoglobin (A1C), blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), body mass index

(BMI), and change in body weight, were assessed.

Results: At baseline, the proportions of patients meeting criteriafor all quality measures were similar between groups. At 52 weeks, compared with sitagliptin 100-mg treatment, canagliflozin 100 mg demonstrated either comparable or superior glycemic control. Additionally, canagliflozin 100 mg versus sitagliptin 100 mg demonstrated superior attainment of BP, BMI, and weight-related quality measures; no difference was seen with respect to LDL-C. At 52 weeks, compared with sitagliptin 100-mg treatment, canagliflozin 300 mg demonstrated superior glycemic control at all thresholds of A1C, and superior BP, BMI, and weight-related quality measures; there was no difference in LDL-C quality measure attainment.

Conclusion: We evaluated the comparative efficacy of canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg on quality measure attainment after 52 weeks of treatment. Compared with sitagliptin 100 mg, canagliflozin 100 mg demonstrated comparable or superior attainment of diabetes-related quality measures. Compared with sitagliptin

100 mg, canagliflozin 300 mg demonstrated superior diabetes-related quality measure attainment, including glycemic, BP, and weight-related quality measures; there was

no difference in LDL-C quality measure attainment between either dosage of canagliflozin and the 100-mg dosage of sitagliptin.

Am J Manag Care. 2014;20:S296-S305

Introduction

In 2012, the total economic burden of diabetes in the United States was $245 billion, of which direct healthcare costs accounted for $176 billion.1 The majority of the cost associated with diabetes care in the United States is due to treatment for complications resulting from poorly controlled diabetes.2 As a result of the high costs of treating diabetes complications, diabetes is a focus of clinical guidelines for care and associated quality measurements to assess and potentially improve quality of care.3 The diabetes-related clinical guidelines on which quality measures are based go beyond just recommendations for glycemic control, due to the association of diabetes with complications such as retinopathy, nephropathy, neuropathy, and cardiovascular disease.4 Evidence-based diabetes-related clinical guidelines are focused on improving outcomes by improving control of diabetes and cardiovascular risk factors, and include glycemic control (as measured by glycated hemoglobin [A1C]), control of blood pressure (BP), lipid control (as assessed by low-density lipoprotein cholesterol [LDL-C] level), and weight management, including reductions in body weight (BW). The goal of this multifaceted approach to diabetes care is to reduce the complications associated with diabetes.

Progress toward improving care in patients with chronic conditions such as diabetes has been the focus of annual quality reports by the Agency for Healthcare Research and Quality since 2003.5 While there has been a general trend toward improvement in diabetes-related quality measures, recent worsening has been observed in some of the measures, including glycemic control. To drive improvement in diabetes-related care, quality measures have been used for benchmarking, quality improvement, public reporting, and incentive programs, such as pay for performance (P4P).6

“Aligning Forces for Quality” is an example of a program, used in several communities, based on quality improvement and public reporting of quality measures.7 The use of P4P programs is continuing to expand in the United States, and P4P programs are in use under both public and private payer sectors of health care.8 Additionally, P4P programs are affecting all stakeholders in healthcare, including payers, institutions, and clinicians. Payer performance is assessed by the National Committee on Quality Assurance Health Effectiveness Data and Information Set program.9 The Centers for Medicare & Medicaid Services’ (CMS’) Accountable Care Organization program holds participating organizations accountable for performance against specific quality measures before shared savings payments can be received.10 Clinicians will be assessed and financially impacted by the CMS Physician Value Based Modifier Program starting in 2015.11

Public reporting of provider performance against quality measures is a core element of P4P programs in place under various state level and national level programs.12-14 The goal of public reporting is to inform patients about the selection of healthcare professionals and to improve clinician performance. A core element of all of these programs is that the attainment of diabetesrelated quality measures is assessed. The diabetes-related quality measures that are used to assess the quality of care include process measures (such as aspirin use and smoking cessation) and intermediate outcome measures, which include the level of glycemic control, BP control, and lipid control.10,15

Quality measures related to BW and body mass index (BMI) are also used in some programs, as approximately 85% of patients with type 2 diabetes mellitus (T2DM) are overweight or obese, and weight loss is an important aspect of T2DM management.4 The Health Resources and Services Administration’s Health Disparities Collaboratives’ measures include a measure of the proportion of patients with a BMI of 25 kg/m2 or higher who have lost 10 lb (4.5 kg) at any time during the past 12 months.16 A BMI of less than 30 kg/m2 is also a quality measure for diabetes approved by Better Health’s Clinical Advisory Committee.17

Antihyperglycemic agents (AHAs) are used to manage diabetes as an adjunct to diet and exercise. The attributes of the available AHAs vary and may differentially affect quality measure attainment. Canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 inhibitor, are approved for use as adjuncts to diet and exercise to improve glycemic control in adults with T2DM.18,19 Two 52-week phase 3 clinical trials sponsored by Janssen Research and Development, LLC, have evaluated the comparative efficacy and safety of canagliflozin and sitagliptin in patients with T2DM.20,21

In the study by Lavalle-González et al, which evaluated patients with T2DM who had inadequate glycemic control on metformin, A1C reductions were similar with canagliflozin 100 mg, and statistically superior with canagliflozin 300 mg, compared with sitagliptin 100 mg. Additionally, both canagliflozin doses (100 mg and 300 mg) demonstrated significantly greater reductions in BW and systolic BP versus sitagliptin 100 mg.20 In the study by Schernthaner et al, which evaluated patients with T2DM who had inadequate glycemic control on metformin plus a sulfonylurea, canagliflozin 300 mg demonstrated statistically superior glycemic control, with similar rates of hypoglycemia and significantly greater reductions in systolic BP and BW compared with sitagliptin 100 mg.21 Both studies reported higher incidences of genital mycotic infections (GMIs) and osmotic diuresis-related adverse events (AEs) in the canagliflozin-treated groups; few AEs led to study discontinuation. The incidence of urinary tract infections (UTIs) was similar across treatment groups in both studies. AEs and AE-related discontinuations were generally comparable across treatment groups.20,21

As diabetes-related quality measures are being used to assess and potentially incentivize diabetes care in a growing number of public and private programs, stakeholders (including payers, healthcare organizations, and healthcare professionals) are increasingly focused on quality measures. As a result, information on the comparative efficacy of AHAs on quality measure attainment is needed to inform decision making.

A published report evaluated the comparative quality measure attainment with canagliflozin 300-mg versus sitagliptin 100-mg treatment in patients previously treated with metformin plus a sulfonylurea based on a post hoc analysis of the study by Schernthaner et al.22 This evaluation showed better attainment of glycemic, BP, and weight-related quality measures for canagliflozin 300 mg compared with sitagliptin 100 mg, and no difference between treatments for the lipid-related quality measure. As payers and healthcare professionals are likely to see a population across the spectrum of AHA treatment, this additional analysis was undertaken to evaluate patients receiving baseline treatment with either metformin alone, or metformin plus a sulfonylurea, to address the increasing need for information on the impact of AHAs on quality measures. The objective of this post hoc analysis was to assess the comparative efficacy of canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg on diabetes-related quality measures after 52 weeks of treatment, using data pooled from the studies by Lavalle- González et al and Schernthaner et al.

MethodsStudy Design and Patient Population

This study used pooled data from 2 prospective, randomized, double-blind phase 3 studies comparing the efficacy of canagliflozin with sitagliptin. Included in this pooled analysis were: (1) patients from the study by Lavalle-González et al who were receiving metformin at baseline and were randomized to receive treatment with canagliflozin 100 mg, canagliflozin 300 mg, or sitagliptin 100 mg20; and (2) patients from the study by Schernthaner et al who were receiving metformin plus a sulfonylurea at baseline and were randomized to receive treatment with canagliflozin 300 mg or sitagliptin 100 mg.21

Both studies pre-specified the assessment of the comparative efficacy of canagliflozin and sitagliptin on the change from baseline in A1C and the proportion of patients attaining A1C less than 7.0%, systolic BP, diastolic BP, LDL-C, and BW at 52 weeks. Details of both studies have been previously reported.20,21 The inclusion and exclusion criteria for both studies were similar, with the exception of the baseline treatments with AHAs (metformin, and metformin plus a sulfonylurea) on which they were not achieving adequate glycemic control (defined as A1C ≥7.0% and ≤10.5% on maximal or near maximal treatment). Only patients randomized to active treatment groups at study initiation were included for the purposes of this analysis; patients randomized to placebo in the study by Lavalle-González et al were excluded.

Those who had a repeated fasting plasma glucose of 300 mg/dL or higher; a history of type 1 diabetes mellitus, cardiovascular disease, or uncontrolled hypertension; or an estimated glomerular filtration rate less than 55 mL/min/1.73 m2 (or <60 mL/min/1.73 m2 if based on restriction in the metformin local label) were excluded from the studies. Both studies were conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with good clinical practice and applicable regulatory requirements. Approvals of the study protocols and amendments were obtained from the institutional review boards of participating institutions. All participants provided written informed consent prior to participation.

Assessments and Statistical Analyses

Change in A1C from baseline to week 52 was a prespecified efficacy end point for both studies. Secondary end points included changes from baseline to week 52 in BP, lipids, BMI, and BW (these data have been reported elsewhere20,21). As both studies evaluated canagliflozin 300 mg and sitagliptin 100 mg at week 52, data from both were pooled for analysis. Because the study by Schernthaner et al did not evaluate canagliflozin 100 mg, only the study by Lavalle-González et al contributed to the canagliflozin 100-mg versus sitagliptin 100-mg comparison.

The pooled efficacy data were used in this post hoc analysis to evaluate the proportion of patients achieving individual quality measures by assessing glycemic control, BP control, lipid control, and BMI and BW at baseline and at 52 weeks (Table 1). Consistent with the previous reports of the clinical studies, analyses were performed using the modified intent-to-treat (mITT) population, consisting of all patients who were randomized and received 1 or more dose of a study drug. Also consistent with the previous study reports, all analyses used the last observation carried forward (LOCF) approach to impute missing data; for patients receiving rescue treatment, the last post baseline value before rescue medication use was carried forward for the analyses imputation.

To allow for quantitative comparisons of canagliflozin and sitagliptin, 95% confidence intervals (CIs) for the between-group differences are reported. Additionally, odds ratios (ORs) and associated 95% CIs at 52 weeks are reported, based on a logistic regression model with treatment, study factors, and baseline values as covariates.

As hypoglycemia may be a concern with more stringent glycemic control, the incidence of hypoglycemia is assessed. Because the use of certain AHAs (such as sulfonylureas) is associated with higher rates of hypoglycemia and the background use of sulfonylureas differed between the studies, the hypoglycemia rates are reported from the individual study populations rather than the pooled study population. Hypoglycemia was assessed as either a documented event with concurrent plasma glucose less than 70 mg/dL or a severe event requiring assistance from another person or resulting in a seizure or loss of consciousness.

AEs potentially related to SGLT2 inhibitor treatment, including GMIs (female and male), UTIs, and symptoms related to osmotic diuresis and volume depletion, are also reported in this pooled population. The osmotic diuresis—related AEs assessed included dry mouth, thirst, polydipsia, and symptoms related to increased urinary output. The AEs assessed relating to volume depletion included those related to hypotension (including postural hypotension), dizziness, presyncope/syncope, and dehydration.

ResultsPatients

Details for each study, including baseline characteristics and patient disposition, have been previously reported.20,21 Briefly, 1856 patients were included in the mITT analysis population for this pooled analysis (canagliflozin 100 mg, n = 368; canagliflozin 300 mg, n = 744; and sitagliptin 100 mg, n = 744) (Table 2). A total of 1346 (72.5%) completed 52 weeks of treatment; details of the reasons for study withdrawal are contained in the individual study reports. The completion rates for the treatment arms were as follows: 81.0% for canagliflozin 100 mg, 74.4% for canagliflozin 300 mg, and 65.5% for sitagliptin 100 mg.

The baseline demographic and disease characteristics were generally similar between treatment groups. Mean baseline A1C and BP control (systolic and diastolic) were similar across groups. After 52 weeks of treatment, the least squares (LS) mean change (standard error [SE]) from baseline in A1C was —0.72% (0.049) for canagliflozin 100 mg, –0.93% (0.031) for canagliflozin 300 mg, and –0.67% (0.031) for sitagliptin 100 mg. The LS mean percentage change (SE) in BW from baseline was –2.9% (0.2) for canagliflozin 100-mg, –3.3% (0.1) for canagliflozin 300- mg, and 0.5% (0.1) for sitagliptin 100-mg treated patients.

Quality Measure Attainment

Quality measure attainment at both baseline and at 52 weeks of treatment is represented in Table 3. For each quality measure, the proportion of each treatment group achieving that measure is represented. Additionally, the between-group differences and the associated 95% CIs are represented. Also presented in Table 3 are ORs, a relative measure allowing for between-group comparisons and corresponding 95% CIs at 52 weeks of treatment.

Canagliflozin 100 mg versus sitagliptin 100 mg

At baseline, the proportions of patients attaining each of the quality measures did not differ between the canagliflozin 100-mg and sitagliptin 100-mg treatment groups, with the exception of LDL-C less than 100 mg/dL (Figure 1). Minor numerical differences were present at baseline; however, the 95% CIs for each included 0 for all of the nonlipid, diabetes-related quality measures. For the LDL-C less than 100 mg/dL measure at baseline, 7.6% more sitagliptin 100-mg treated patients attained this measure at baseline, with a 95% CI that excluded zero.

At 52 weeks of treatment, canagliflozin 100 mg demonstrated similar or better glycemic control compared with sitagliptin 100 mg (Figure 1). Similar proportions of patients attained A1C less than 7.0%, with 41.4% of canagliflozin 100-mg and 42.8% of sitagliptin 100-mg treated patients attaining this measure. Canagliflozin 100 mg performed better than sitagliptin 100 mg for glycemic measures of A1C less than 8.0% (good control) and A1C greater than 9.0% (poor control); 8.2% more patients on canagliflozin 100 mg achieved an A1C less than 8.0% and 4.1% fewer patients on canagliflozin 100 mg had an A1C greater than 9.0% (95% CIs for between-group differences excluded 0, and 95% CIs for ORs excluded 1). After 52 weeks of treatment, attainment of all BP quality measures favored canagliflozin 100 mg versus sitagliptin 100 mg; 13.4% more patients (95% CI, 7.0- 19.8) attained BP less than 130/80 mm Hg, 11.4% more patients (95% CI, 5.0-17.8) attained BP less than 140/80 mm Hg, and 9.7% more patients (95% CI, 4.9-14.5) attained BP less than 140/90 mm Hg. The 95% CIs for the ORs reflecting the on-treatment differences after 52 weeks of treatment excluded 1 for each BP-related quality measure. The minor imbalances observed at baseline between canagliflozin 100 mg and sitagliptin 100 mg persisted after 52 weeks of treatment for the LDL-C less than 100 mg/dL measure. The 95% CI for the OR reflecting the on-treatment differences after 52 weeks of treatment included 1, indicating that there was no difference between treatment groups in attaining the LDL-C quality measure.

For the BMI-related quality measures, canagliflozin 100 mg and sitagliptin 100 mg had relatively similar proportions of patients with a BMI less than 30 kg/m2 at both baseline and 52 weeks. For the change in BW quality measure evaluating a weight loss of greater than 10 lb (4.5 kg) in 12 months for those with a BMI of 25 kg/ m2 or greater, 19.6% more canagliflozin 100-mg treated patients met this measure compared with those treated with sitagliptin 100 mg (95% CI for between-group differences 14.3-24.9). The corresponding OR for this measure after 52 weeks of treatment excluded 1.

Canagliflozin 300 mg versus sitagliptin 100 mg

At baseline, the proportions of patients attaining all of the diabetes-related quality measures were similar between the canagliflozin 300-mg and sitagliptin 100-mg treatment groups. After 52 weeks of treatment, canagliflozin 300 mg performed better for all glycemic control quality measures (Figure 2). For A1C less than 7.0%, 8.3% (95% CI, 3.0- 13.5) more canagliflozin 300-mg treated patients attained this measure than sitagliptin 100-mg treated patients; the corresponding OR was 1.51 (95% CI, 1.20-0.90). For A1C less than 8.0% (good control), 12.7% (95% CI, 8.3- 17.1) more canagliflozin 300-mg treated patients attained this measure than sitagliptin 100-mg treated patients; the corresponding OR was 2.42 (95% CI, 1.84-3.19). The proportion of patients with an A1C greater than 9.0% (poor control) was 4.5% (95% CI, —6.8 to –2.2) lower for canagliflozin 300 mg than for sitagliptin 100 mg.

Attainment of all BP quality measures favored canagliflozin 300 mg over sitagliptin 100 mg at 52 weeks: 12.2% (95% CI, 7.0-17.4) more patients at BP less than 130/80 mm Hg; 11.0% (95% CI, 5.7-16.2) more patients at BP less than 140/80 mm Hg; and 9.2% (95% CI, 5.2- 13.3) more patients at BP less than 140/90 mm Hg. The ORs at 52 weeks of treatment for each of the BP quality measures favored canagliflozin 300 mg compared with sitagliptin 100 mg, and the associated 95% CIs excluded 1.

Minor differences in the proportions of patients achieving LDL-C less than 100 mg/dL between the canagliflozin 300-mg and sitagliptin 100-mg treatment groups were present at baseline. The 95% CI reflecting the on-treatment differences after 52 weeks of treatment included 1, indicating that there was no difference between treatment groups in attaining the LDL-C quality measure.

For both the BMI and BW related quality measures, canagliflozin 300 mg demonstrated better attainment than sitagliptin 100 mg. At 52 weeks, 10.4% (95% CI, 5.1-15.6) more canagliflozin 300-mg treated patients than sitagliptin 100-mg treated patients had a BMI less than 30 kg/m2. The corresponding OR at 52 weeks was 3.48 (95% CI, 2.11-5.75). For the measure evaluating a weight loss of more than 10 lb (4.5 kg) in those with BMI of 25 kg/ m2 or higher at baseline, 15.2% (95% CI, 11.3-19.1) more canagliflozin 300-mg treated patients than sitagliptin 100- mg treated patients attained this goal. The corresponding OR at 52 weeks excluded 1.

Safety

In patients treated with metformin at baseline, documented episodes of hypoglycemia occurred in 6.8% of patients with both doses of canagliflozin (100 mg and 300 mg) and 4.1% of sitagliptin 100-mg treated patients. Severe hypoglycemia occurred in 1 patient treated with canagliflozin 100 mg and 1 patient treated with sitagliptin 100 mg. In patients treated with metformin plus a sulfonylurea at baseline, documented episodes of hypoglycemia occurred in 43.2% of canagliflozin 300-mg and 40.7% of sitagliptin 100-mg treated patients; the canagliflozin 100-mg dose was not evaluated in this population. Severe hypoglycemia occurred in 4.0% of canagliflozin 300-mg treated patients and 3.4% of sitagliptin 100-mg treated patients.

GMIs occurred in 11.3% of canagliflozin 100-mg treated female patients, 12.4% of canagliflozin 300-mg treated female patients, and 3.4% of sitagliptin 100-mg treated female patients. GMIs occurred in 5.2% of canagliflozin 100-mg treated male patients, 6.2% of canagliflozin 300- mg treated male patients, and 0.8% of sitagliptin 100-mg treated male patients. UTIs occurred in 7.9% of canagliflozin 100-mg treated patients, 4.4% of canagliflozin 300-mg treated patients, and 5.9% of sitagliptin 100-mg treated patients.

Osmotic diuresis—related AEs occurred in 8.2% of canagliflozin 100-mg treated patients, 4.7% of canagliflozin 300-mg treated patients, and 2.2% of sitagliptin 100-mg treated patients. These osmotic diuresis–related AEs rarely led to study drug discontinuation (0.3% for canagliflozin 100-mg treated patients, 0.4% for canagliflozin 300-mg treated patients, and 0.1% of sitagliptin 100-mg treated patients). Volume depletion-related AEs occurred in 1.1% of canagliflozin 100-mg treated patients, 1.3% of canagliflozin 300-mg treated patients, and 2.0% of sitagliptin 100-mg treated patients.

Discussion

This post hoc analysis evaluated the attainment of individual diabetes-related quality measures in patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg, using pooled data from two 52-week, randomized, double-blind, controlled, phase 3 clinical trials that were designed to evaluate the comparative efficacy of canagliflozin and sitagliptin. Additionally, this analysis used the same statistical methodologies as the original reports, specifically evaluating the mITT population and using LOCF to impute missing data.20,21 With these above factors in mind, this analysis of the comparative clinical trials allows for direct comparison of diabetesrelated quality measure attainment among canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg.

Canagliflozin 100 mg provided similar or better attainment of quality measures related to glycemic control, better attainment of BP-related quality measures, and better attainment of the change in weight in overweight or obese patients with T2DM quality measure. There was no difference between canagliflozin 100 mg and sitagliptin with respect to the LDL-C quality measure as reflected by the OR after 52 weeks of treatment.

Canagliflozin 300 mg provided better attainment of diabetes-related quality measures related to glycemic control, BP control, and BMI and BW at 52 weeks compared with sitagliptin 100 mg. There was no difference between canagliflozin 300 mg and sitagliptin 100 mg with respect to attainment of the LDL-C quality measure.

Canagliflozin has been associated with increases from baseline in LDL-C.18 In the clinical trials included in this analysis, the groups treated with canagliflozin 100 mg and canagliflozin 300 mg both had larger increases in LDL-C compared with the groups treated with sitagliptin 100 mg.20,21 However, attainment of the LDL-C level less than 100 mg/dL was generally similar with canagliflozin and sitagliptin in this analysis. Thus, the proportion of patients achieving the LDL-C target was comparable, despite the increases in LDL-C observed with canagliflozin. There were no differences in the use of lipidmodifying medications, including statins.

Because the background AHA treatment differed between studies included in this analysis, the rates of hypoglycemia were reported for each study. The canagliflozin 100-mg treatment group in this pooled analysis included only patients treated with metformin at baseline, whereas the canagliflozin 300-mg and sitagliptin 100-mg treatment groups included patients treated with either metformin alone or metformin plus a sulfonylurea, a class of AHA that increases the risk of hypoglycemia.18,19 In the study by Lavalle-González et al, which evaluated the addition of canagliflozin or sitagliptin in patients not at A1C goal on metformin, the observed rates of biochemically documented hypoglycemia were higher with both doses of canagliflozin compared with sitagliptin 100 mg20; there was no difference in the rate of severe hypoglycemia. The study by Schernthaner et al evaluated the addition of canagliflozin 300 mg or sitagliptin 100 mg in patients not at A1C goal on metformin plus a sulfonylurea. The results of this study showed that rates of hypoglycemia (biochemically documented or severe) were similar between treatment groups and that canagliflozin-treated patients achieved significantly better glycemic control compared with sitagliptin-treated patients.21

The findings from this post hoc analysis are consistent with those from the previously reported clinical trials demonstrating comparable glycemic control with canagliflozin 100 mg and better glycemic control with canagliflozin 300 mg compared with sitagliptin 100 mg. Also consistent with the clinical trial reports was the greater reduction of systolic BP and BW with both canagliflozin 100 mg and canagliflozin 300 mg compared with sitagliptin 100 mg. These findings suggest that there may be additional potential value in the attainment of diabetesrelated quality measures compared with sitagliptin. When these improvements in quality measure attainment are applied to a large population of people with T2DM, this would translate to improved treatment outcomes for a large number of patients.

A limitation of this study was that the canagliflozin 100-mg treatment group comprised only patients treated with metformin at baseline, whereas the canagliflozin 300-mg and sitagliptin 100-mg treatment groups included patients treated with either metformin alone or metformin plus a sulfonylurea. Patients treated with other AHAs were not evaluated in this analysis, nor were special populations, such as older adults or patients with renal impairment. Additional studies in a real-world setting may be warranted to further inform the comparative effectiveness of canagliflozin compared with other AHAs, including sitagliptin, on the attainment of diabetes-related quality measures.

Conclusion

Compared with sitagliptin 100 mg, canagliflozin 100 mg demonstrated comparable or superior attainment of diabetes-related quality measures, including comparable or superior glycemic control, superior BP control, and superior impact on weight-related quality measures. Compared with sitagliptin 100 mg, canagliflozin 300 mg demonstrated superior diabetes-related quality measure attainment including glycemic, BP, and weight-related quality measures. These findings from this analysis of data from 2 phase 3 clinical trials provide insights on the comparative efficacy of 2 oral AHAs on diabetes-related quality measures. This information may be relevant to stakeholders increasingly focused on quality measures and population health management such as payers, healthcare delivery organizations, and clinicians.Acknowledgments

This analysis was funded by Janssen Scientific Affairs, LLC. Editorial support was provided by Bilge Yoruk, PhD, of Excerpta Medica, and was funded by Janssen Scientific Affairs, LLC.

Author affiliations: Health Economics and Outcomes Research, Janssen Scientific Affairs, LLC, Raritan, NJ (RAB, MFTR); Ochsner Diabetes Clinical Research Unit, Department of Endocrinology, Diabetes, and Metabolic Diseases, Ochsner Medical Center, New Orleans, LA (LB); Janssen Research and Development, LLC, Raritan, NJ (GEM, UV). Funding source: This supplement was supported by Janssen Pharmaceuticals, Inc.

Author disclosures: Drs Bailey and Rupnow report employment with Janssen Scientific Affairs, LLC (a Johnson & Johnson company), and stock ownership with Johnson & Johnson. Dr Blonde reports receipt of grants from Eli Lilly and Company, Novo Nordisk, and sanofiaventis. Dr Blonde also reports receipt of honoraria from AstraZeneca, Janssen Pharmaceuticals, Inc, Merck & Co, Inc, Novo Nordisk, Quest Diagnostics, and sanofi-aventis. Drs Meininger and Vijapurkar report employment with Janssen Research and Development, LLC, and stock ownership with Johnson & Johnson.

Authorship information: Concept and design (RAB, MFTR); acquisition of data (RAB, GEM,UV); analysis and interpretation of data (RAB, LB, GEM, MFTR, UV); drafting of the manuscript (RAB, LB, GEM, MFTR, UV); critical revision of the manuscript for important intellectual content (RAB, LB, GEM, MFTR, UV); statistical analysis (MFTR, UV); provision of study materials or patients (GEM); obtaining funding (MFTR); and supervision (RAB).

Address correspondence to: Robert A. Bailey, MD, 1000 US Route 202, Raritan, NJ 08869. E-mail: rbailey5@its.jnj.com.

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