Ochsner Diabetes Clinical Research Unit

New Orleans, LA, United States

Ochsner Diabetes Clinical Research Unit

New Orleans, LA, United States
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Banerji M.A.,SUNY Downstate Medical Center | Baron M.A.,Sanofi S.A. | Gao L.,Sanofi S.A. | Blonde L.,Ochsner Diabetes Clinical Research Unit
Postgraduate Medicine | Year: 2014

Purpose: Optimizing glycemic control in patients with type 2 diabetes mellitus (T2DM) not controlled with ≥ 1 oral antidiabetes drugs (OADs) is challenging. Many therapeutic options exist; however, data comparing the effectiveness of different strategies are lacking for the management of patients with T2DM. Our study aim was to provide comparative data on efficacy and hypoglycemia when initiating insulin glargine (glargine) versus alternative treatment options (not including the newest antidiabetes agents, glucagon-like peptide [GLP]-1 receptor agonists, dipeptidyl peptidase [DPP]-4 inhibitors or sodium-glucose linked transporter [SGLT]-2 inhibitors) in insulin-naive patients with T2DM who remained uncontrolled with OADs. Methods: Patient-level data were pooled from 9 randomized controlled trials of ≥ 24 weeks duration with comparable patient populations. The effect of adding glargine was compared with intensification of lifestyle interventions or OADs, addition of neutral protamine Hagedorn (NPH) insulin, insulin lispro, premixed insulin, or all comparators pooled, on patient glycated hemoglobin (HbA1c) level, fasting plasma glucose level, weight, and hypoglycemia. Results: A greater proportion of patients achieved a target HbA1c level ≤ 7.0% with glargine treatment than with pooled comparators, intensification of OADs, or lifestyle interventions; there was no difference when compared with NPH, premixed, or insulin lispro use. The rate for reported hypoglycemic events was lower for glargine use than for pooled comparators or other insulins, but higher compared with intensification of lifestyle interventions or OADs. When stratified by baseline HbA1c level, efficacy/target attainment with glargine use was better than for pooled comparators across all HbA1c strata; OAD intensification, when baseline HbA1c level was ≥ 8.0%; and premixed insulin if baseline HbA1c level was < 8.0%; but similar to other insulins for all other categories. The incidence of reported hypoglycemia was less frequent with glargine use than other insulins, but more frequent than intensification of lifestyle interventions or OADs. Conclusion: When adequate glycemic control is not achieved using OADs in patients with T2DM, initiating insulin glargine is generally less likely to elicit hypoglycemia than initiating NPH, premixed, or prandial insulins, and the benefit–risk balance supports initiating insulin rather than intensification of OAD therapy when baseline HbA1c level is ≥ 8.0%. © Postgraduate Medicine.


Blonde L.,Ochsner Diabetes Clinical Research Unit | Baron M.A.,Sanofi S.A. | Zhou R.,Medpace | Banerji M.A.,SUNY Downstate Medical Center
Postgraduate Medicine | Year: 2014

Background: Cardiovascular risk factors (CVRFs) may complicate optimization of therapy in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetes drugs (OADs). We assessed the influence of patient baseline CVRFs on efficacy and rate of hypoglycemia with use of insulin glargine (glargine) added to ongoing OAD treatment compared with alternative therapeutic options; namely, intensification of lifestyle interventions or adding OADs, neutral protamine Hagedorn (NPH), lispro, or premixed insulin in patients failing OADs. Methods: Patient-level data were pooled from 9 randomized controlled trials of glargine and comparators for 24 weeks in insulin-naive patients with T2DM inadequately controlled on OADs. Efficacy (goal attainment—glycated hemoglobin (HbA1c) level ≤ 7.0% or decrease ≥ 1.0% change from baseline) and hypoglycemia rates (symptomatic, confirmed, nocturnal, or severe) were compared for patients treated with glargine (n = 1462) and pooled (n = 1476) and individual comparators, overall; and in patients with hypertension (∼69%), dyslipidemia (∼58%), history of cardiovascular disease (∼25%), or any CVRF (∼83%) at baseline. Results: The patient groups were well-balanced at baseline (HbA1c level 8.7%; diabetes duration, 8.6 years). Use of glargine was associated with greater patient goal attainment (57.7% vs 51.4% for HbA1c level ≤ 7.0%; P < 0.001), modestly larger reductions in HbA1c level (−1.68% vs −1.51%; P , 0.001), and less symptomatic hypoglycemia than occurred with pooled comparators, regardless of patient CVRFs (5.04 vs 7.01 events/patient-year of exposure, respectively; P < 0.001). Reductions in HbA1c level and hypoglycemia rates were significantly greater with glargine use than with intensification of OADs or lifestyle modifications, overall, and in patients with any CVRF. Reductions in HbA1c level were greater and hypoglycemia rates lower with use of glargine compared with premixed insulin, overall, and in patients with any CVRF. Reductions in HbA1c level were similar and hypoglycemia rates lower with use of glargine, NPH, and lispro insulin, regardless of patient CVRFs. Conclusion: The glycemic benefits of glargine use compared with alternative therapeutic options are maintained without excess hypoglycemia in patients with CVRFs. © Postgraduate Medicine.


Testa M.A.,Harvard University | Gill J.,Sanofi S.A. | Su M.,Multi-phase Technologies, Llc | Turner R.R.,Multi-phase Technologies, Llc | And 2 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: In patients with diabetes, intraday glucose variability might predict health outcomes independently from glycosylated hemoglobin (HbA 1c). Objective: Our objective was to evaluate patient satisfaction (PS), quality of life (QoL), glycemic control, and variability during insulin intensification to HbA1c below 7.0%. Patients, Design, and Setting: Eighty-two type 1 and 306 insulin-treated type 2 diabetes patients (47% male; age 54 ± 11 yr; HbA1c = 7.8 ± 0.7%) participated in this multicenter, randomized, crossover trial at 52 U.S. centers. Interventions: Interventions included insulin glargine plus premeal glulisine (n = 192) vs. twice-daily premix 75/25 or 70/30 analog insulin (n = 196) for 12 wk and crossed to the alternate arm for 12 wk. Main Outcome Measures: Main outcome measures included PS and QoL questionnaires, 3-d continuous glucose monitoring (CGM), and HbA1c every 4-8 wk. Results: Mean ± SE HbA1c change was -0.39 ± 0.09% for glargine-glulisine and -0.05 ± 0.09% for premix (P < 0.0001). The PS net benefit scale (0-100) improved from 51.1 to 60.5 ± 1.2 for glargine-glulisine and worsened to 45.4 ± 1.2 for premix (P < 0.0001). The PS regimen acceptance scale was comparable (P = 0.33). Overall QoL favored glargine-glulisine (P < 0.001), as did perceived health (P < 0.0001), symptom distress (P < 0.0001), general health perceptions (P < 0.01), and psychosocial (P < 0.02). CGM daily glucose mean, daily glucose SD (glycemic variability), and percent time over 140 mg/dl were lower for glargine-glulisine by 13.1 ± 2.7 mg/dl, 5.9 ± 1.4 mg/dl, and 7.3 ± 1.6%, respectively (all P < 0.0001), with no difference in CGM percent time below 70 mg/dl (P = 0.09). Symptomatic hypoglycemia rates were comparable. HbA1c, mean CGM daily glucose, and glycemic variability were independent predictors of PS net benefit. Conclusions: Patient satisfaction was impacted more positively by improved QoL, reduced glucose variability, and better glycemic control with a basal-bolus regimen than negatively by the burden of additional injections, thereby facilitating insulin intensification and the ability to achieve HbA1c below 7.0%. Copyright © 2012 by The Endocrine Society.


Buse J.B.,University of North Carolina at Chapel Hill | Sesti G.,University of Catanzaro | Schmidt W.E.,Ruhr University Bochum | Montanya E.,University of Barcelona | And 4 more authors.
Diabetes Care | Year: 2010

OBJECTIVE - To evaluate efficacy and safety of switching from twice-daily exenatide to once-daily liraglutide or of 40 weeks of continuous liraglutide therapy. RESEARCH DESIGN AND METHODS - When added to oral antidiabetes drugs in a 26-week randomized trial (Liraglutide Effect and Action in Diabetes [LEAD]-6), liraglutide more effectively improved A1C, fasting plasma glucose, and the homeostasis model of β-cell function (HOMA-B) than exenatide, with less persistent nausea and hypoglycemia. In this 14-week extension of LEAD-6, patients switched from 10 μg twice-daily exenatide to 1.8 mg once-daily liraglutide or continued liraglutide. RESULTS - Switching from exenatide to liraglutide further and significantly reduced A1C (0.32%), fasting plasma glucose (0.9 mmol/l), body weight (0.9 kg), and systolic blood pressure (3.8 mmHg) with minimal minor hypoglycemia (1.30 episodes/patient-year) or nausea (3.2%). Among patients continuing liraglutide, further significant decreases in body weight (0.4 kg) and systolic blood pressure (2.2 mmHg) occurred with 0.74 episodes/patient-year of minor hypoglycemia and 1.5% experiencing nausea. CONCLUSIONS - Conversion from exenatide to liraglutide is well tolerated and provides additional glycemic control and cardiometabolic benefits. © 2010 by the American Diabetes Association.


Garber A.J.,Baylor College of Medicine | Blonde L.,Ochsner Diabetes Clinical Research Unit | Bloomgarden Z.T.,Mount Sinai School of Medicine | Handelsman Y.,Metabolic Institute of America | Dagogo-Jack S.,University of Tennessee Health Science Center
Endocrine Practice | Year: 2013

Objective: To review available data on the efficacy and safety of bromocriptine-QR (BQR) and to consider its role in the management of Type 2 diabetes mellitus (T2DM). Methods: Published literature reporting the efficacy and safety of BQR in the treatment of T2DM was reviewed, including peer-reviewed abstracts and poster presentations. Results: BQR is an oral hypoglycemic agent with a novel mechanism of action that appears to involve enhancement of morning central nervous system (CNS) dopaminergic activity, resulting in improved insulin sensitivity and reduced hepatic glucose output. Adjunctive treatment with BQR in the dosing range of 1.6 to 4.8 mg/d may result in a mean (95% confidence interval [CI]) reduction in glycated hemoglobin (A1c) levels of 0.69% (0.97%, 0.41%). Treatment with BQR appears to be associated with minimal intrinsic risk of hypoglycemia, and does not appear to be associated with clinically significant adverse effects on weight, triglycerides, free fatty acids, or blood pressure. Conclusion: The favorable cardiovascular risk profile of BQR suggests that it may be useful in the treatment of patients with T2DM with a history of cardiovascular disease (CVD) or who have significant risk factors for CVD. However, knowledge of the efficacy and safety of BQR is limited by the relatively small clinical trials database. As a result, there is currently insufficient information on the safety and efficacy of adjunctive BQR in T2DM patients being treated with several common diabetes regimens (e.g., thiazolidinediones, insulin). Copyright © 2013 AACE.


Blonde L.,Ochsner Diabetes Clinical Research Unit | Montanya E.,University of Barcelona
Diabetes, Obesity and Metabolism | Year: 2012

The two classes of incretin-related therapies, dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), have become important treatment options for patients with type 2 diabetes. Sitagliptin, saxagliptin, vildagliptin and linagliptin, the available DPP-4 inhibitors, are oral medications, whereas the GLP-1 RAs-twice-daily exenatide, once-weekly exenatide and once-daily liraglutide-are administered subcutaneously. By influencing levels of GLP-1 receptor stimulation, these medications lower plasma glucose levels in a glucose-dependent manner with low risk of hypoglycaemia, affecting postprandial plasma glucose more than most other anti-hyperglycaemic medications. Use of GLP-1 RAs has been shown to result in greater glycaemic improvements than DPP-4 inhibitors, probably because of higher levels of GLP-1 receptor activation. GLP-1 RAs can also produce significant weight loss and may reduce blood pressure and have beneficial effects on other cardiovascular risk factors. Although both classes are well tolerated, DPP-4 inhibitors may be associated with infections and headaches, whereas GLP-1 RAs are often associated with gastrointestinal disorders, primarily nausea. Pancreatitis has been reported with both DPP-4 inhibitors and GLP-1 RAs, but a causal relationship between use of incretin-based therapies and pancreatitis has not been established. In clinical trials, liraglutide has shown efficacy and tolerability and resulted in certain significant benefits when compared with exenatide and sitagliptin. © 2012 Blackwell Publishing Ltd.


Blonde L.,Ochsner Diabetes Clinical Research Unit
American Journal of Medicine | Year: 2010

Type 2 diabetes mellitus and obesity are associated with increased cardiovascular risk. While lifestyle interventions such as medical nutrition therapy and appropriately prescribed physical activity remain cornerstones of disease prevention and treatment, most patients with type 2 diabetes will eventually require pharmacotherapy for glycemic control. Fortunately, many of these patients are able to achieve desired glycemic targets with the use of currently available antihyperglycemic agents. Both not-for-profit disease-specific organizations and healthcare specialty societies have provided guidance about the appropriate selection of these therapies. Type 2 diabetes treatment guidelines and algorithms have been developed, taking into account a combination of evidence-based information and expert opinions, with various groups offering diverse glucose goals and approaches to hyperglycemia management. Virtually all recognize that type 2 diabetes is a multifaceted disease, necessitating an integrated yet individualized approach to patient care. © 2010.


PubMed | Ochsner Diabetes Clinical Research Unit
Type: Journal Article | Journal: Postgraduate medicine | Year: 2014

Cardiovascular risk factors (CVRFs) may complicate optimization of therapy in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetes drugs (OADs). We assessed the influence of patient baseline CVRFs on efficacy and rate of hypoglycemia with use of insulin glargine (glargine) added to ongoing OAD treatment compared with alternative therapeutic options; namely, intensification of lifestyle interventions or adding OADs, neutral protamine Hagedorn (NPH), lispro, or premixed insulin in patients failing OADs.Patient-level data were pooled from 9 randomized controlled trials of glargine and comparators for 24 weeks in insulin-naive patients with T2DM inadequately controlled on OADs. Efficacy (goal attainment-glycated hemoglobin (HbA1c) level 7.0% or decrease 1.0% change from baseline) and hypoglycemia rates (symptomatic, confirmed, nocturnal, or severe) were compared for patients treated with glargine (n = 1462) and pooled (n = 1476) and individual comparators, overall; and in patients with hypertension (~69%), dyslipidemia (~58%), history of cardiovascular disease (~25%), or any CVRF (~83%) at baseline.The patient groups were well-balanced at baseline (HbA1c level 8.7%; diabetes duration, 8.6 years). Use of glargine was associated with greater patient goal attainment (57.7% vs 51.4% for HbA1c level 7.0%; P < 0.001), modestly larger reductions in HbA1c level (-1.68% vs -1.51%; P < 0.001), and less symptomatic hypoglycemia than occurred with pooled comparators, regardless of patient CVRFs (5.04 vs 7.01 events/patient-year of exposure, respectively; P < 0.001). Reductions in HbA1c level and hypoglycemia rates were significantly greater with glargine use than with intensification of OADs or lifestyle modifications, overall, and in patients with any CVRF. Reductions in HbA1c level were greater and hypoglycemia rates lower with use of glargine compared with premixed insulin, overall, and in patients with any CVRF. Reductions in HbA1c level were similar and hypoglycemia rates lower with use of glargine, NPH, and lispro insulin, regardless of patient CVRFs.The glycemic benefits of glargine use compared with alternative therapeutic options are maintained without excess hypoglycemia in patients with CVRFs.


PubMed | Ochsner Diabetes Clinical Research Unit
Type: | Journal: Diabetes, obesity & metabolism | Year: 2012

The two classes of incretin-related therapies, dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), have become important treatment options for patients with type 2 diabetes. Sitagliptin, saxagliptin, vildagliptin and linagliptin, the available DPP-4 inhibitors, are oral medications, whereas the GLP-1 RAs-twice-daily exenatide, once-weekly exenatide and once-daily liraglutide-are administered subcutaneously. By influencing levels of GLP-1 receptor stimulation, these medications lower plasma glucose levels in a glucose-dependent manner with low risk of hypoglycaemia, affecting postprandial plasma glucose more than most other anti-hyperglycaemic medications. Use of GLP-1 RAs has been shown to result in greater glycaemic improvements than DPP-4 inhibitors, probably because of higher levels of GLP-1 receptor activation. GLP-1 RAs can also produce significant weight loss and may reduce blood pressure and have beneficial effects on other cardiovascular risk factors. Although both classes are well tolerated, DPP-4 inhibitors may be associated with infections and headaches, whereas GLP-1 RAs are often associated with gastrointestinal disorders, primarily nausea. Pancreatitis has been reported with both DPP-4 inhibitors and GLP-1 RAs, but a causal relationship between use of incretin-based therapies and pancreatitis has not been established. In clinical trials, liraglutide has shown efficacy and tolerability and resulted in certain significant benefits when compared with exenatide and sitagliptin.

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