Vivian A Fonseca

Southeast Louisiana Veterans Health Care System, Джексон, Alabama, United States

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Publications (160)687.91 Total impact

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    ABSTRACT: The transcription factor Pax4 plays a critical role in the determination of α- vs β-cell lineage during endocrine pancreas development. In this study, we explored whether Pax4 gene transfer into α- cells could convert them into functional β-cells, and thus provide therapeutic benefits for insulin-deficient diabetes. We found that Pax4 delivered by adenoviral vector, Ad5.Pax4, induced insulin expression and reduced glucagon expression in αTC1.9 cells. More importantly, these cells exhibited glucose-stimulated insulin secretion, a key feature of functional β-cells. When injected into streptozotocin-induced diabetic mice, Pax4-treated αTC1.9 cells significantly reduced blood glucose, and the mice showed better glucose tolerance, supporting that Pax4 gene transfer into αTC1.9 cells resulted in the formation of functional β-cells. Furthermore, treatment of primary human islets with Ad5.Pax4 resulted in significantly improved β-cell function. Detection of glucagon(+)/Pax4(+)/Insulin(+) cells argued for Pax4-induced α-to-β cell transitioning. This was further supported by quantification of glucagon and insulin bi-hormonal cells, which was significantly higher in Pax4-treated islets than in controls. Finally, direct administration of Ad5.Pax4 into the pancreas of insulin-deficient mice ameliorated hyperglycemia. Taken together, our data demonstrate that manipulating Pax4 gene expression represents a viable therapeutic strategy for the treatment of insulin deficient diabetes.Molecular Therapy (2015); doi:10.1038/mt.2015.181.
    Molecular Therapy 10/2015; DOI:10.1038/mt.2015.181 · 6.23 Impact Factor
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    ABSTRACT: Evaluate the performance of glycated albumin (GA) monitoring by comparing it to other measures of glycemic control during intensification of antidiabetic therapy. This 12-week, prospective, multicenter study compared the diagnostic clinical performance of GA to A1C, fructosamine corrected for albumin (FRA), fasting plasma glucose (FPG), and mean blood glucose estimated from self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM) in 30 patients with suboptimally controlled type 1 or type 2 diabetes. Mean A1C decreased from 9.5% to 8.1%. Mean SMBG correlated closely with CGM (Pearson r=0.783 for daily estimates and r=0.746 for weekly estimates; P<0.001). Both GA and FRA levels significantly correlated with changes from baseline in A1C and mean weekly SMBG (P<0.001).The lowest observed median GA occurred at 4 weeks, followed by a small increase and then a slight reduction, mirroring changes in overall mean SMBG values. The median A1C fell throughout the treatment period, failing to reflect short-term changes in SMBG. A ≥1% reduction in GA at 4 weeks was significantly associated with a ≥0.5% change in A1C at 12 weeks (odds ratio [OR] = 19.0, [95% CI: 1.4, 944], P=0.018). In patients receiving glucose-lowering therapy, changes in GA at 4 weeks were concordant with changes in A1C at 12 weeks and both GA and FRA more accurately reflected short-term blood glucose fluctuations than A1C.
    Endocrine Practice 07/2015; DOI:10.4158/EP14570.OR · 2.81 Impact Factor
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    Lizheng Shi · Xin Ye · Mei Lu · Eric Q Wu · Hari Sharma · Darren Thomason · Mengxi Zhang · Yao Wang · Vivian A Fonseca ·
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    ABSTRACT: A majority of patients with diabetes do not have levels of glycated hemoglobin (HbA1c) and low-density lipoprotein cholesterol (LDL-C) under control, either individually or in combination. The objective was to assess the clinical benefits and patient characteristics associated with dual-goal achievement [HbA1c <7% (53 mmol/mol) and LDL-C <100 mg/dL] versus only LDL-C goal achievement in adults with newly diagnosed type 2 diabetes. Newly diagnosed patients with ≥2 measures of LDL-C and HbA1c were identified in the South Central Veterans Affairs Health Care Network (01/2004-06/2010). The index date was the first HbA1c assessment within 3 months of the first type 2 diabetes diagnosis. Multivariate Cox proportional hazards models were used to assess the association between time-varying goal achievement and post-index microvascular and cardiovascular complications. Patient characteristics associated with dual-goal achievement in the 7-12 months post-index were identified using a logistic regression. The sample included 16,829 patients. Compared with LDL-C goal achievement, dual-goal achievement was associated with lower risk of microvascular complications [hazard ratio (95% confidence interval): 0.69 (0.63, 0.76)]. Other outcomes did not differ between those two groups. Characteristics associated with dual-goal achievement (44.2% of patients) include prior dual-goal achievement, older age, and use of lipid-lowering drugs. Dual-goal achievement in newly diagnosed type 2 diabetes is associated with a lower risk of microvascular complications versus only LDL-C goal achievement. Although dual-goal achievement rates are suboptimal, early and regular intervention will increase its likelihood. Daiichi Sankyo, Inc., Parsippany, NJ, USA.
    07/2015; 6(3). DOI:10.1007/s13300-015-0122-2
  • Jay S Skyler · Vivian A Fonseca · Karen R Segal · Julio Rosenstock ·
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    ABSTRACT: To assess the safety, tolerability, and feasibility of adult allogeneic bone marrow-derived mesenchymal precursor cells (MPCs) in type 2 diabetes inadequately controlled with metformin either alone or with one additional oral antidiabetic agent. The study was a dose-escalating randomized placebo-controlled trial assessing one intravenous (IV) infusion of MPCs (rexlemestrocel-L; Mesoblast Inc.) 0.3 × 10(6)/kg (n = 15), 1.0 × 10(6)/kg (n = 15), or 2.0 × 10(6)/kg (n = 15) or placebo (n = 16). Study duration was 12 weeks. Subjects (21 women, 40 men) with a mean ± SD baseline HbA1c 8.3 ± 1.0% (67 ± 10.9 mmol/mol), BMI 33.5 ± 5.5 kg/m(2), and diabetes duration 10.1 ± 6.0 years were enrolled at 18 U.S. sites. No acute adverse events (AEs) were associated with infusion. No serious AEs, serious hypoglycemia AEs, or discontinuations due to AEs over 12 weeks were found. No subjects developed donor-specific anti-HLA antibodies or became sensitized. The safety profile was comparable among treatment groups. Compared with placebo, a single IV infusion of rexlemestrocel-L reduced HbA1c at all time points after week 1. The adjusted least squares mean ± SE dose-related differences in HbA1c from placebo in the rexlemestrocel-L groups ranged from -0.1 ± 0.2% (-1.1 ± 2.2 mmol/mol) to -0.4 ± 0.2% (4.4 ± 2.2 mmol/mol) at 8 weeks and from 0.0 ± 0.25% to -0.3 ± 0.25% (-3.3 ± -2.7 mmol/mol) at 12 weeks (P < 0.05 for 2.0 × 10(6)/kg dose at 8 weeks). The clinical target HbA1c <7% (53 mmol/mol) was achieved by 33% (5 of 15) of the subjects who received the 2.0 × 10(6)/kg dose vs. 0% of those who received placebo (P < 0.05). This short-term study demonstrates the safety and feasibility of up to 246 million MPCs in subjects with type 2 diabetes. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
    Diabetes care 07/2015; 38(9). DOI:10.2337/dc14-2830 · 8.42 Impact Factor
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    Harvey W Kaufman · Zhen Chen · Vivian A Fonseca · Michael J McPhaul ·
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    ABSTRACT: Twenty-six states and the District of Columbia expanded Medicaid in January 2014 pursuant to the Affordable Care Act (ACA); 24 states did not. This created an opportunity to examine the impact of Medicaid expansion on the number of Medicaid patients with newly identified diabetes among enrollees (19-64 years of age) who had laboratory testing through Quest Diagnostics. Newly identified diabetes was defined as an ICD-9 diagnosis code of 250.x (diabetes) or hemoglobin A1c of >6.4% (46 mmol/mol) within the first 6 months of a calendar year and the absence of both in the preceding calendar year within our data repository. We identified 215,398 and 218,890 patients who met our definition of newly diagnosed diabetes within the first 6 months of 2013 (control period) and 2014 (study period), respectively (a 1.6% increase). We identified 26,237 Medicaid-enrolled patients with new diabetes in the control period vs. 29,673 in the study period: an increase of 13%. The number of Medicaid-enrolled patients with newly identified diabetes increased by 23% (14,625 vs. 18,020 patients) in the 26 states (and District of Columbia) that expanded Medicaid compared with an increase of 0.4% (11,612 vs. 11,653 patients) in the 24 states that did not expand Medicaid during this period. Similar differences were observed in younger and older adults and for both men and women. This study suggests that in the states that expanded Medicaid under the ACA, an increased number of Medicaid patients with diabetes are being diagnosed and treated earlier. This could be anticipated to lead to better long-term outcomes. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
    Diabetes care 03/2015; 38(5). DOI:10.2337/dc14-2334 · 8.42 Impact Factor
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    ABSTRACT: Aims: Patients with type 2 diabetes (T2DM) and chronic kidney disease (CKD) have impaired endothelial function. Vitamin D and its analogs may play a role in regulation of endothelial function and inflammation. We studied effects of paricalcitol compared to placebo on endothelial function and markers of inflammation and oxidative stress in patients with T2DM and CKD. Methods: A double blind, randomized, placebo-controlled trial was conducted in 60 patients with T2DM and stage 3 or 4 CKD. Paricalcitol 1 mcg or placebo was administered orally once daily for three months. Brachial artery flow mediated dilatation (FMD), nitroglycerine mediated dilation (NMD), and plasma concentrations of inflammatory cytokines, tumor necrosis factor -α and interleukin-6, highly-sensitive C-reactive protein; endothelial surface proteins, intercellular adhesion molecule -1 and monocyte chemo attractant protein-1, and plasma glucose, insulin, free fatty acids, and urinary isoprostane were measured at baseline and end of three months. Results: 27 patients in the paricalcitol group and 28 patients in the control group completed the study, though analysis of FMD at both time points was possible in 23 patients in each group. There was no significant difference in the change in FMD, NMD or the biomarkers examined after paricalcitol or placebo treatment. Conclusions: Treatment with paricalcitol at this dose and duration did not affect brachial artery FMD or biomarkers of inflammation and oxidative stress. The lack of significance may be due to the fact that the study patients had advanced CKD and that effects of paricalcitol are not additive to the effects of glycemic, lipid and anti-hypertensive therapies.
    Journal of Diabetes and its Complications 01/2015; 29(3). DOI:10.1016/j.jdiacomp.2015.01.004 · 3.01 Impact Factor
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    ABSTRACT: Adults with diabetes typically take multiple medications for hyperglycemia, diabetes-associated conditions, and other comorbidities. Medication adherence is associated with improved outcomes, including reduced health care costs, hospitalization, and mortality. We conducted a retrospective analysis of a large pharmacy claims database to examine patient, medication, and prescriber factors associated with adherence to antidiabetic medications. We extracted data on a cohort of >200,000 patients who were treated for diabetes with noninsulin medications in the second half of 2010 and had continuous prescription benefits eligibility through 2011. Adherence was defined as a medication possession ratio ≥0.8. We used a modified adherence measure that accounted for switching therapies. Logistic regression analysis was performed to determine factors independently associated with adherence. Sixty-nine percent of patients were adherent. Adherence was independently associated with older age, male sex, higher education, higher income, use of mail order versus retail pharmacies, primary care versus nonendocrinology specialist prescribers, higher daily total pill burden, and lower out-of-pocket costs. Patients who were new to diabetes therapy were significantly less likely to be adherent. Several demographic, clinical, and potentially modifiable system-level factors were associated with adherence to antidiabetic medications. Patients typically perceived to be healthy (those who are younger, new to diabetes, and on few other medications) may be at risk for nonadherence. For all patients, efforts to reduce out-of-pocket costs and encourage use of mail order pharmacies may result in higher adherence. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
    Diabetes Care 01/2015; 38(4). DOI:10.2337/dc14-2098 · 8.42 Impact Factor
  • Thomas J O'Malley · Genevieve E Fava · Yanqing Zhang · Vivian A Fonseca · Hongju Wu ·
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    ABSTRACT: Glucagon-like Peptide 1 (GLP-1) and glucagon shares the same precursor molecule proglucagon, but each arises from a distinct posttranslational process in a tissue-specific manner. Recently it has been shown that GLP-1 is co-expressed with glucagon in pancreatic islet cells. This study was aimed to investigate the progressive changes of GLP-1 vs glucagon production in pancreatic islets during the course of diabetes development. Both type 1 (NOD mice) and type 2 (db/db mice) diabetes models were employed in this study. The mice were monitored closely for their diabetes progression, and were sacrificed at different stages according to their blood glucose levels. GLP-1 and glucagon expression in the pancreatic islets was examined using immunohistochemistry assays. Quantitative analysis was performed to evaluate the significance of the changes. The ratio of GLP-1-expressing cells to glucagon expressing cells in the islets showed significant, progressive increase with the development of diabetes in db/db mice. The increase of GLP-1 expression was in accordance with the upregulation of PC1/3 expression in these cells. Interestingly, intra-islet GLP-1 expression was not significantly changed during the development of type 1 diabetes in NOD mice. The study demonstrated GLP-1 was progressively up-regulated in pancreatic islets during type 2 diabetes development. In addition, the data suggest clear differences in intra-islet GLP-1 production between type 1 and type 2 diabetes developments. These differences may have an impact on the clinical and pathophysiological processes of these diseases and may be a target for therapeutic approaches. This article is protected by copyright. All rights reserved.
    Diabetes/Metabolism Research and Reviews 11/2014; 30(8). DOI:10.1002/dmrr.2534 · 3.55 Impact Factor
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    ABSTRACT: Objective: Effective treatment algorithms are needed to guide diabetes care at hospital discharge in general medicine and surgery patients with type 2 diabetes. Research design and methods: This was a prospective, multicenter open-label study aimed to determine the safety and efficacy of a hospital discharge algorithm based on admission HbA1c. Patients with HbA1c <7% (53.0 mmol/mol) were discharged on their preadmission diabetes therapy, HbA1c between 7 and 9% (53.0-74.9 mmol/mol) were discharged on a preadmission regimen plus glargine at 50% of hospital daily dose, and HbA1c >9% were discharged on oral antidiabetes agents (OADs) plus glargine or basal bolus regimen at 80% of inpatient dose. The primary outcome was HbA1c concentration at 12 weeks after hospital discharge. Results: A total of 224 patients were discharged on OAD (36%), combination of OAD and glargine (27%), basal bolus (24%), glargine alone (9%), and diet (4%). The admission HbA1c was 8.7 ± 2.5% (71.6 mmol/mol) and decreased to 7.3 ± 1.5% (56 mmol/mol) at 12 weeks of follow-up (P < 0.001). The change of HbA1c from baseline at 12 weeks after discharge was -0.1 ± 0.6, -0.8 ± 1.0, and -3.2 ± 2.4 in patients with HbA1c <7%, 7-9%, and >9%, respectively (P < 0.001). Hypoglycemia (<70 mg/dL) was reported in 22% of patients discharged on OAD only, 30% on OAD plus glargine, 44% on basal bolus, and 25% on glargine alone and was similar in patients with admission HbA1c ≤7% (26%) compared with those with HbA1c >7% (31%, P = 0.54). Conclusions: Measurement of HbA1c on admission is beneficial in tailoring treatment regimens at discharge in general medicine and surgery patients with type 2 diabetes.
    Diabetes Care 08/2014; 37(11). DOI:10.2337/dc14-0479 · 8.42 Impact Factor
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    ABSTRACT: Objective: GLP-1 receptor agonists may provide an alternative to prandial insulin for advancing basal insulin therapy. Harmony 6 was a randomized, open-label, active-controlled trial testing once-weekly albiglutide vs. thrice-daily prandial insulin lispro as an add-on to titrated once-daily insulin glargine. Research design and methods: Patients taking basal insulin (with or without oral agents) with HbA1c 7-10.5% (53-91 mmol/mol) entered a glargine standardization period, followed by randomization to albiglutide, 30 mg weekly (n = 282), subsequently uptitrated to 50 mg, if necessary, or thrice-daily prandial lispro (n = 281) while continuing metformin and/or pioglitazone. Glargine was titrated to fasting plasma glucose of <5.6 mmol/L, and lispro was adjusted based on glucose monitoring. The primary end point was the difference in the HbA1c change from baseline at week 26. Results: At week 26, HbA1c decreased from baseline by -0.82 ± SE 0.06% (9.0 mmol/mol) with albiglutide and -0.66 ± 0.06% (7.2 mmol/mol) with lispro; treatment difference, -0.16% (95% CI -0.32 to 0.00; 1.8 mmol/mol; P < 0.0001), meeting the noninferiority end point (margin, 0.4%). Weight decreased with albiglutide but increased with lispro (-0.73 ± 0.19 kg vs. +0.81 ± 0.19 kg). The mean glargine dose increased from 47 to 53 IU (albiglutide) and from 44 to 51 IU (lispro). Adverse events for albiglutide versus lispro included severe hypoglycemia (0 vs. 2 events), documented symptomatic hypoglycemia (15.8% vs. 29.9%), nausea (11.2% vs. 1.4%), vomiting (6.7% vs. 1.4%), and injection site reactions (9.5% vs. 5.3%). Conclusions: Weekly albiglutide is a simpler therapeutic option than thrice-daily lispro for advancing basal insulin glargine therapy, resulting in comparable HbA1c reduction with weight loss and lower hypoglycemia risk.
    Diabetes Care 06/2014; 37(8). DOI:10.2337/dc14-0001 · 8.42 Impact Factor
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    Gandahari Rosa A Carpio · Vivian A Fonseca ·
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    ABSTRACT: The American Diabetes Association emphasizes the importance of individualized patient care in the management of diabetes. One of the important considerations in choosing an antihyperglycemic agent is its side-effect and safety profile. This article reviews the common and clinically significant side effects of each class of agents, including ways to prevent and overcome their occurrence.
    Diabetes Spectrum 05/2014; 27(2):92-100. DOI:10.2337/diaspect.27.2.92
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    ABSTRACT: Aims To quantify the effect of liraglutide on systolic blood pressure (SBP) and pulse in patients with type 2 diabetes (T2D), and assess the influence of covariates on observed SBP reductions. Methods A patient-level pooled analysis of six phase 3, randomized trials was conducted. Results The analysis included 2792 randomized patients. In the intention-to-treat population (n = 2783), mean [± SE] SBP reductions from baseline with liraglutide 1.2 mg (2.7 [0.8] mmHg) and 1.8 mg (2.9 [0.7] mmHg) once daily were significantly greater than with placebo (0.5 [0.9] mmHg; P = 0.0029 and P = 0.0004, respectively) after 26 weeks, and were evident after 2 weeks. Liraglutide was also associated with significantly greater SBP reductions than glimepiride and, at a dose of 1.8 mg, insulin glargine and rosiglitazone. SBP reductions with liraglutide weakly correlated with weight loss (Pearson’s correlation coefficient: 0.08-0.12; P ≤ 0.0148). No dependence of these reductions on concomitant antihypertensive medications was detected (P = 0.1304). Liraglutide 1.2 and 1.8 mg were associated with mean increases in pulse of 3 beats per minute (bpm), versus a 1 bpm increase with placebo (P < 0.0001 for each dose versus placebo). Conclusions Liraglutide reduces SBP in patients with T2D, including those receiving concomitant antihypertensive medication.
    Journal of diabetes and its complications 05/2014; 28(3). DOI:10.1016/j.jdiacomp.2014.01.009 · 3.01 Impact Factor
  • Vivian A. Fonseca ·
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    ABSTRACT: Background Suboptimal blood glucose control among patients with type 2 diabetes continues to support the need for new pharmacologic approaches. Objective The purpose of this commentary was to highlight newly available and soon-to-be available agents that are promising tools for targeting specific pathophysiologic pathways in the management of diabetes. Methods Published evidence to support the application of novel incretin-based therapies, dipeptidyl peptidase (DPP)-4 inhibitors, sodium-glucose cotransporter (SGLT)-2 inhibitors, other oral agents and insulins for managing specific aspects of type 2 diabetes, as well as disadvantages associated with those novel medications, are discussed. Results Several new glucagon-like peptide (GLP)-1 receptor agonists with different time frames of action, although each has unique advantages and disadvantages, have been through clinical trials. Examples of these are lixisenatide and albiglutide. Currently available DPP-4 inhibitor agents, important for inhibiting the breakdown of endogenous GLP-1, have not been associated with weight gain or hypoglycemia. SGLT-2 inhibitors, which do not depend on insulin secretion or insulin action, may be advantageous in that they appear to be broadly efficacious at all stages of diabetes. New insulin analogues, such as degludec and U-500, improve glycemic control without contributing to hypoglycemia. Conclusions Advances in pharmacologic options offer the promise of improving glycemic control for longer periods, with limited glycemic fluctuations, hypoglycemia, and weight gain. However, the effectiveness of these agents ultimately depends on their availability to providers managing the health care of patients at high risk for poor diabetes outcomes and patients’ use of them as directed. Long-term effectiveness and safety trials are ongoing.
    Clinical Therapeutics 04/2014; 36(4). DOI:10.1016/j.clinthera.2014.01.018 · 2.73 Impact Factor
  • Vivian A Fonseca · Michelle A Haggar ·
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    ABSTRACT: Insulin therapy is an effective method for reducing blood glucose levels in patients with type 2 diabetes mellitus (T2DM), and most patients with T2DM eventually require insulin replacement to attain and preserve satisfactory glycaemic control. All patients with T2DM should be considered as potential candidates for intensive insulin treatment; however, there are certain considerations regarding replacement therapy for different types of people and special populations, such as patients with multiple comorbidities, adolescents, pregnant women and the elderly. Lowering HbA1c levels in isolation without assessing the patient as a whole is becoming redundant. HbA1c targets should be individualized to the specific patient, and insulin treatment ought to be customized accordingly. There are several questions that need to be taken into account when considering adding insulin therapy to other oral antidiabetic agents, for example, for whom and when insulin therapy is indicated and which basal insulin should be utilized. Potential barriers exist related to patients, providers and health-care systems that can delay the start of insulin therapy, and every effort should be made to identify and address these obstacles.
    Nature Reviews Endocrinology 02/2014; 10(5). DOI:10.1038/nrendo.2014.17 · 13.28 Impact Factor
  • Michelle Haggar · Vivian Fonseca ·
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    ABSTRACT: This chapter presents an overview of the background history of diabetic nephropathy. The discovery of diabetic renal disease was a gradual process and the definition of diabetic nephropathy has changed over time. Initial studies of renal biopsies, radioimmunoassay, and the concept of micro- and macroalbuminuria are highlighted, as well as the discovery of renin–angiotensin–aldosterone system (RAAS). Landmark trials focusing on how diabetic nephropathy could be improved using pharmacologic blockade of RAAS are reviewed. Diabetes is the most common cause of end-stage renal disease in Western countries, and trials that highlight the benefit of treating hyperglycemia are presented.
    Diabetes and Kidney Disease, 01/2014: pages 1-5; , ISBN: 978-1-4939-0792-2
  • Vivian A Fonseca ·

    Journal of diabetes and its complications 10/2013; 28(1). DOI:10.1016/j.jdiacomp.2013.09.005 · 3.01 Impact Factor
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    Wenjing Zhao · Lizheng Shi · Vivian A Fonseca · Jiang He · Decheng Shao · Jie Zhao · Qingmei Chen · Aitian Yin ·

    Diabetes care 09/2013; 36(9):e159-60. DOI:10.2337/dc13-1007 · 8.42 Impact Factor
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    ABSTRACT: To evaluate the efficacy and safety of initial combination therapy of sitagliptin 100 mg/day coadministered with all marketed doses of pioglitazone in patients with type 2 diabetes. Patients with A1C ≥7.5% and ≤11.0% were randomized among 7 arms that received, once daily, 100 mg sitagliptin alone, 15, 30, or 45 mg pioglitazone alone, or 100 mg sitagliptin plus 15, 30, or 45 mg pioglitazone for 54 weeks. The primary endpoint was change from baseline in A1C at Week 24. Protocol-specified analyses compared combination therapies with monotherapies at respective dose-strengths and combination of sitagliptin plus pioglitazone 30 mg with pioglitazone 45 mg monotherapy. Post-hoc analyses compared sitagliptin plus pioglitazone 15 mg with pioglitazone monotherapy at the two higher doses. Initial combination therapy with sitagliptin and pioglitazone provided significantly greater reductions in A1C (0.4-0.7% differences) and other glycemic endpoints than either monotherapy at the same doses. Combining sitagliptin with low-dose pioglitazone generally produced greater glycemic improvements than higher doses of pioglitazone monotherapy (0.3-0.4% differences in A1C ). Combination therapy was generally well tolerated; AEs of hypoglycemia were reported with similar incidence (7.8-11.1%) in all treatment groups over the 54 weeks of study; edema was reported in 0.5% of patients in the sitagliptin monotherapy group and 2.7-5.3% among pioglitazone-treated groups. Significant weight gain was observed in all combination-treated groups compared with the sitagliptin monotherapy group. Initial combination therapy with sitagliptin and pioglitazone provided better glycemic control than either monotherapy and was generally well tolerated.
    Diabetes Obesity and Metabolism 08/2013; 16(3). DOI:10.1111/dom.12194 · 6.36 Impact Factor
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    ABSTRACT: To determine differences in inpatient glycemic control and response to two different glargine-based insulin regimens in general medicine and surgery patients with type 2 diabetes (T2D). This is a post-hoc analysis of a prospective, multicenter, randomized trial of 298 non-ICU medicine and surgery patients with T2D treated with Basal Bolus regimen with glargine once daily and glulisine before meals and with Basal Plus regimen with glargine once daily and supplemental doses of glulisine before meals for blood glucose (BG)>140mg/dl. Major study outcomes included differences in mean daily BG, frequency of treatment failures (defined as >2 consecutive BG>240mg/dl or a mean daily BG>240mg/dl), and hypoglycemia between the medicine and surgery cohorts. Patients treated with Basal Bolus or with Basal Plus experienced similar improvement in mean daily BG after 1st day of therapy (p=0.16), number of treatment failures (p=0.11) and hypoglycemic events (p=0.50). Compared to surgery patients (n=130), medicine patients (n=168) had higher admission BG (p=0.01) and HbA1c levels (p<0.01); however, they had similar response to either treatment regimen without differences in mean daily BG after 1st day of therapy (p=0.18), number of treatment failures (p=0.58), daily insulin requirements (p=0.36), or in the frequency of hypoglycemia (p=0.79). The Basal Plus regimen with glargine once daily and correction doses with glulisine before meals resulted in similar glycemic control to basal bolus regimen. We observed no differences in response to either basal insulin regimen between medicine and surgery patients with type 2 diabetes.
    Journal of diabetes and its complications 08/2013; 27(6). DOI:10.1016/j.jdiacomp.2013.05.007 · 3.01 Impact Factor
  • Vanita R Aroda · Vivian A Fonseca ·

    American journal of preventive medicine 08/2013; 45(2):246-7. DOI:10.1016/j.amepre.2013.05.001 · 4.53 Impact Factor

Publication Stats

4k Citations
687.91 Total Impact Points


  • 2015
    • Southeast Louisiana Veterans Health Care System
      Джексон, Alabama, United States
  • 1999-2015
    • Tulane University
      • Department of Medicine
      New Orleans, Louisiana, United States
  • 2013
    • MedStar Health Research Institute
      Maryland, United States
  • 2003-2011
    • Louisiana State University Health Sciences Center New Orleans
      • • Department of Medicine
      • • Section of Pediatric Endocrinology
      New Orleans, Louisiana, United States
  • 2009
    • Texas A&M University System Health Science Center
      • Scott and White Clinic
      Bryan, Texas, United States
    • University of Lille Nord de France
      Lille, Nord-Pas-de-Calais, France
  • 2004
    • University of Nebraska Medical Center
      Omaha, Nebraska, United States
  • 1997-2002
    • University of Arkansas at Little Rock
      Little Rock, Arkansas, United States
  • 2001
    • Central Arkansas Veterans Healthcare System
      Washington, Washington, D.C., United States