Texas Diabetes and Endocrinology

Austin, TX, United States

Texas Diabetes and Endocrinology

Austin, TX, United States
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Wysham C.,Redwood Clinic | Blevins T.,Texas Diabetes and Endocrinology | Arakaki R.,University of Hawaii at Manoa | Garcia P.,Autonomous University of Nuevo León | And 3 more authors.
Diabetes Care | Year: 2014

OBJECTIVE: To compare the efficacy and safety of dulaglutide, a once-weekly GLP-1 receptor agonist, with placebo and exenatide in type 2 diabetic patients. The primary objective was to determine superiority of dulaglutide 1.5 mg versus placebo in HbA1c change at 26 weeks. RESEARCH DESIGN AND METHODS: This 52-week, multicenter, parallel-arm study (primary end point: 26 weeks) randomized patients (2: 2: 2: 1) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, exenatide 10 mg, or placebo (placebo-controlled period: 26 weeks). Patients were treated with metformin (1,500-3,000 mg) and pioglitazone (30-45 mg). Mean baseline HbA1c was 8.1% (65 mmol/mol). RESULTS: Least squares mean ± SE HbA1c change from baseline to the primary end point was 21.51 ± 0.06% (216.5 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, 21.30 ± 0.06% (214.2 ± 0.7 mmol/mol) for dulaglutide 0.75 mg, 20.99 ± 0.06% (210.8 ± 0.7 mmol/mol) for exenatide, and 20.46 ± 0.08% (25.0 ± 0.9 mmol/mol) for placebo. Both dulaglutide doses were superior to placebo at 26 weeks (both adjusted one-sided P < 0.001) and exenatide at 26 and 52 weeks (both adjusted one-sided P < 0.001). Greater percentages of patients reached HbA1c targets with dulaglutide 1.5 mg and 0.75 mg than with placebo and exenatide (all P < 0.001). At 26 and 52 weeks, total hypoglycemia incidence was lower in patients receiving dulaglutide 1.5 mg than in those receiving exenatide; no dula-glutide-treated patients reported severe hypoglycemia. The most common gastrointestinal adverse events for dulaglutide were nausea, vomiting, and diarrhea. Events were mostly mild to moderate and transient. CONCLUSIONS: Both once-weekly dulaglutide doses demonstrated superior glycemic control versus placebo and exenatide with an acceptable tolerability and safety profile. © 2014 by the American Diabetes Association.

Buse J.B.,University of North Carolina at Chapel Hill | Vilsboll T.,Copenhagen University | Thurman J.,SSM Medical Group | Blevins T.C.,Texas Diabetes and Endocrinology | And 3 more authors.
Diabetes Care | Year: 2014

OBJECTIVE: Insulin degludec/liraglutide (IDegLira) is a novel combination of insulin degludec (IDeg) and liraglutide. This trial investigated the contribution of the liraglutide component of IDegLira versus IDeg alone on efficacy and safety in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: In a 26-week, double-blind trial, patients with type 2 diabetes (A1C 7.5 -10.0% [58- 86 mmol/mol]) on basal insulin (20- 40 units) and metformin with or without sulfonylurea/glinides were randomized (1:1) to once-daily IDegLira + metformin or IDeg + metformin with titration aiming for fasting plasma glucose between 4 and 5mmol/L. Maximumallowed doseswere 50 dose steps (equal to 50 units IDeg plus 1.8mg liraglutide) and 50 units for IDeg. The primary end point was change in A1C from baseline. RESULTS: A total of 413 patients were randomized (mean A1C 8.8% [73 mmol/mol]; BMI 33.7 kg/ m2). IDeg dose, alone or as part of IDegLira, was equivalent (45 units). A1C decreased by 1.9% (21 mmol/mol) with IDegLira and by 0.9% (10 mmol/mol) with IDeg (estimated treatment difference -1.1% [95% CI -1.3, -0.8], 212mmol/mol [95% CI -14, -9; P < 0.0001). Mean weight reduction with IDegLira was 2.7 kg vs. no weight change with IDeg, P < 0.0001. Hypoglycemia incidence was comparable (24% for IDegLira vs. 25% for IDeg). Overall adverse events were similar, and incidence of nausea was low in both groups (IDegLira 6.5% vs. IDeg 3.5%). CONCLUSIONS: IDegLira achieved glycemic control superior to that of IDeg at equivalent insulin doses without higher risk of hypoglycemia and with the benefit of weight loss. These findings establish the efficacy and safety of IDegLira and the distinct contribution of the liraglutide component. © 2014 by the American Diabetes Association.

Rosenstock J.,Dallas Diabetes and Endocrine Center | Bergenstal R.M.,International Diabetes Center at Park Nicollet | Blevins T.C.,Texas Diabetes and Endocrinology | Morrow L.A.,Profil Institute for Clinical Research Inc. | And 5 more authors.
Diabetes Care | Year: 2013

OBJECTIVEdTo compare effects of LY2605541 versus insulin glargine on daily mean blood glucose as part of a basal-bolus regimen for type 1 diabetes. RESEARCH DESIGNANDMETHODSdIn this randomized, Phase 2, open-label, 232 crossover study, 137 patients received once-daily basal insulin (LY2605541 or glargine) plus mealtime insulin for 8 weeks, followed by crossover treatment for 8 weeks. Daily mean blood glucose was obtained from 8-point self-monitored blood glucose profiles. The noninferiority margin was 10.8 mg/dL. RESULTSdLY2605541 met noninferiority and superiority criteria compared with insulin glargine in daily mean blood glucose (144.2 vs. 151.7 mg/dL, least squares mean difference = 29.9 mg/dL [90% CI 214.6 to 25.2], P < 0.001). Fasting blood glucose variability and A1C were reduced with LY2605541 compared with insulin glargine (both P < 0.001). Mealtime insulin dose decreased with LY2605541 and increased with insulin glargine. Mean weight decreased 1.2 kg with LY2605541 and increased 0.7 kg with insulin glargine (P,0.001). The total hypoglycemia rate was higher for LY2605541 (P = 0.04) and the nocturnal hypoglycemia rate was lower (P = 0.01), compared with insulin glargine. Adverse events (including severe hypoglycemia) were similar, although more gastrointestinal-related events occurred with LY2605541 (15% vs. 4%, P < 0.001). Mean changes (all within normal range) were higher for alanine aminotransferase, aspartate aminotransferase, triglycerides, and LDL-cholesterol and lower for HDL-cholesterol with LY2605541 compared with insulin glargine (all P < 0.02). CONCLUSIONSdIn type 1 diabetes, compared with insulin glargine, LY2605541, a novel, long-acting basal insulin, demonstrated greater improvements in glycemic control, increased total hypoglycemia, and reduced nocturnal hypoglycemia, as well as reducedweight and lowered mealtime insulin doses. Copyright © 2013 by the American Diabetes Association.

Blevins T.,Texas Diabetes and Endocrinology
Postgraduate Medicine | Year: 2010

Type 2 diabetes mellitus and comorbidities related to overweight/obesity are risk factors for the development of cardiovascular disease (CVD). In addition to insulin resistance and progressive β-cell failure as key factors in the pathogenesis of type 2 diabetes mellitus, defects in the incretin system are now known to contribute as well. Lifestyle modifications including diet and exercise are often insufficient for reducing glucose and weight, and most patients with type 2 diabetes will require pharmacotherapy to treat their hyperglycemia. Goals of therapy should be to reduce blood glucose to as low as possible, for as long as possible, without weight gain and hypoglycemia, and correcting cardiovascular risk factors. Numerous antidiabetes medications lower blood glucose; however, many are associated with weight gain and do not address risk factors present for CVD. Newer pharmacotherapies include the glucagon-like peptide-1 (GLP- 1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and amylinomimetics. The GLP-1 receptor agonists and amylinomimetics reduce glucose while promoting weight loss and improving other cardiovascular risk factors with a low incidence of hypoglycemia. The DPP-4 inhibitors effectively lower glucose and are weight neutral. © Postgraduate Medicine.

Blevins T.,Texas Diabetes and Endocrinology | Pieber T.R.,Medical University of Graz | Colon Vega G.,American Telemedicine Center | Zhang S.,Eli Lilly and Company | And 3 more authors.
Diabetes, Obesity and Metabolism | Year: 2016

Aims: To evaluate the efficacy and safety of basal insulin peglispro (BIL) with those of insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (T2D). Methods: In this phase III, multicentre, double-blind, 26-week study, we randomized patients with T2D [glycated haemoglobin (HbA1c) ≥7 and <12%, on ≥1 insulin injections daily) to BIL (n = 691) or glargine (n = 678), in combination with lispro. Results: At week 26, the primary objective of non-inferiority of BIL versus glargine for HbA1c reduction was achieved (least squares mean difference −0.21%; 95% confidence interval −0.31 to −0.11%), with statistical superiority of BIL with multiplicity adjustment (p < 0.001). HbA1c at baseline was 8.4% versus 8.5% for BIL versus glargine and at 26 weeks it was 6.8% versus 7.0%. At 26 weeks, more patients reached HbA1c <7% with BIL than with glargine (63.3% vs 53.3%; p < 0.001), the nocturnal hypoglycaemia rate (≤3.9 mmol/l) was lower with BIL (0.51 vs 0.92 events/30 days; p < 0.001), but the daytime hypoglycaemia rate was higher with BIL (5.47 vs 4.53 events/30 days; p < 0.001). The total hypoglycaemia relative rate was 1.10 (p = 0.053). At 26 weeks, patients in the BIL group had lower fasting serum glucose levels, higher basal insulin dosing, with no statistically significant difference in prandial or total insulin dosing, reduced glucose variability and less weight gain (1.3 kg vs 2.2 kg) compared with the glargine group. The BIL group had higher mean triglyceride and aminotransferase levels. Conclusions: In patients with T2D, BIL with insulin lispro provided greater improvement in glycaemic control with less nocturnal hypoglycaemia, lower glucose variability and less weight gain compared with glargine. The daytime hypoglycaemia rate and mean triglyceride and aminotransferase levels were higher with BIL. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Blevins T.,Texas Diabetes and Endocrinology | Pullman J.,Mercury St. Medical | Malloy J.,Amylin Pharmaceuticals Inc. | Yan P.,Corporate Analytics | And 4 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2011

Context: We wanted to understand the effects of once-weekly vs. twice-daily glucagon-like peptide-1 receptor agonism for treatment of patients with type 2 diabetes. Objective: The objective of the study was to compare effects of exenatide once weekly (ExQW) and exenatide twice daily (ExBID) on glycemic control, body weight, and safety. Design: This was a 24-wk, randomized, open-label, comparator-controlled study. Setting: The study was conducted at 43 sites in the United States. Patients: The study population was 252 intent-to-treat patients with type 2 diabetes [baseline (mean ± SD): glycosylated hemoglobin (HbA1c) 8.4 ± 1.2%, fasting plasma glucose 171 ± 47 mg/dl, weight 96 ± 20 kg] that were drug naïve (19%) or previously treated with one (47%) or multiple (35%) oral antidiabetic medications. Interventions: Interventions included ExQW 2 mg for 24 wk or ExBID 5 μg for 4 wk followed by ExBID 10 μg for 20 wk. Main Outcome Measure: The change in HbA1c from baseline to wk 24 was measured. Results: At 24 wk, ExQW produced significantly greater changes from baseline (least squares mean ± SE) vs. ExBID in HbA1c (-1.6 ± 0.1% vs. -0.9 ± 0.1%; P < 0.0001) and fasting plasma glucose (-35 ± 5 mg/dl vs. -12 ± 5 mg/dl; P = 0.0008). Similar reductions in mean body weight from baseline to wk 24 were observed in both groups (-2.3 ± 0.4 kg and -1.4 ± 0.4 kg). Both treatments were generally well tolerated. Transient and predominantly mild to moderate nausea, the most frequent adverse event, was less common with ExQW (14%) than with ExBID (35%). Injection-site reactions were infrequent, but more common with ExQW. No major hypoglycemia occurred. Conclusions: Continuous glucagon-like peptide-1 receptor agonism with ExQW resulted in superior glycemic control, with less nausea, compared with ExBID in patients with type 2 diabetes. Both groups lost weight. Copyright © 2011 by The Endocrine Society.

Blevins T.C.,Texas Diabetes and Endocrinology
Journal of Diabetes Science and Technology | Year: 2010

Professional continuous glucose monitoring (PCGM) is a 3-5 day test done to evaluate diabetes control. The PCGM test uses interstitial glucose measurements done every 5 min with a glucose-oxidase-impregnated membrane. The PCGM test evaluates glucose control retrospectively with the glucose results being unknown to the patient until the results are downloaded after the testing period. The PCGM test allows the practitioner and patient to evaluate the effect of diet, physical activity, medications, and lifestyle events on glucose control during the 24 h period. Developing a PCGM program at a medical office involves understanding reimbursement issues and having trained staff and a process in place to initiate the test and download and interpret the data. © Diabetes Technology Society.

Introduction: For patients with type 2 diabetes mellitus (T2DM), there is a growing interest in sodium glucose co-transporter 2 (SGLT2) inhibitors, a class of glucose-lowering agents that act independently of insulin secretion and insulin action and also have a weight-lowering effect. Empagliflozin is an SGLT2 inhibitor that has been demonstrated to significantly reduce blood glucose levels and is well tolerated in patients with T2DM.Areas covered: Kovacs et al. have reported a randomized, placebo-controlled study of empagliflozin as add-on to pioglitazone or pioglitazone plus metformin in patients with T2DM. The study results are evaluated, and potential impact on clinical practice is considered.Expert opinion: The addition of empagliflozin to pioglitazone or pioglitazone plus metformin treatment may offer some advantages. Together, their complementary mechanisms of action result in significant reductions in glycated hemoglobin levels, weight, and blood pressure, with a low risk of hypoglycemia, but were associated with an increased risk of events consistent with genital mycotic infections. © 2015 Informa UK, Ltd.

Blevins T.,Texas Diabetes and Endocrinology
Postgraduate Medicine | Year: 2011

The importance of maintaining effective glycemic control in patients with type 2 diabetes mellitus (T2DM) is well known. It is increasingly recognized that postprandial hyperglycemia is an important component of the overall glycemic burden, though there is as yet a paucity of data showing that lowering of postprandial plasma glucose (PPG) reduces risk of T2DM complications. The contribution of PPG to overall glycemic control is greatest when glycated hemoglobin (HbA1c) is approximately 7% to 8%. Clinical studies show that targeting PPG can improve glycemic control and long-term prognosis in patients with T2DM. Guidelines for T2DM management now include target levels for PPG as treatment goals. One effective approach to PPG control is achieved using mealtime administration of insulin with a rapid onset of effect and a short duration of action, so that PPG excursions are limited without increased risk of hypoglycemia. Basal-bolus and biphasic insulin regimens achieve good PPG control, even in patients unable to reach glycemic targets with other treatments. Although clinical studies are increasingly including PPG as an endpoint, more interventional studies are needed to investigate the effect of different treatment regimens on PPG and the effect of PPG on clinical outcome. This will facilitate future recommendations for the most effective treatment of T2DM. Postprandial glucose is an important glycemic burden in many patients; routine targeting and regular monitoring has potential to ameliorate the cardiovascular complications of T2DM. © Postgraduate Medicine.

Blevins T.,Texas Diabetes and Endocrinology
Postgraduate medicine | Year: 2013

Self-monitoring of blood glucose (SMBG) levels provides important information regarding glycemic control for patients with diabetes, and is recommended by European and American diabetes organizations as an essential adjunct to periodic glycated hemoglobin (HbA1c) level monitoring. The benefits of SMBG in improving glycemic control in patients with type 1 diabetes and those with type 2 diabetes (T2DM) who are being treated with insulin are well recognized. In contrast, the potential role of SMBG in patients with T2DM not treated with insulin remains controversial, which may lead to underutilization of SMBG in this population. Structured SMBG, introduced as part of a treatment intervention, has been associated with modest but significant improvements in HbA1c levels in patients with T2DM who are not taking insulin as part of their management plan. Patient-obtained readings provide valuable real-time feedback on glucose responses to meals and exercise, and provide the patient with guidance on the day-to-day management of their diabetes. Studies have shown that when patients perform self-monitoring as part of their treatment interventions, support through appropriate educational initiatives is critical to ensure that patients understand the rationale for SMBG. Patients should be trained in correct testing technique and data recording for SMBG, as well as target blood glucose and goal HbA1c levels so that they will know when their SMBG readings are out of range. Technology has a potential role in facilitating SMBG-based interventions by improving patient-physician communication and optimizing glycemic control through the use of remote data uploading, data analysis tools, and, perhaps, even text messaging. This review outlines the benefits of SMBG in the management of patients with T2DM not treated with insulin, and highlights strategies for improving the effectiveness of SMBG-based treatment interventions in this population.

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