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Julio Rosenstock - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of lixilan a titratable fixed ratio combination of lixisenatide and Insulin Glargine versus Insulin Glargine in type 2 diabetes inadequately controlled on metformin monotherapy the lixilan proof of concept randomized trial
Diabetes Care, 2016Co-Authors: Julio Rosenstock, Michaela Diamant, Vanita R Aroda, Louise Silvestre, Elisabeth Souhami, Tianyue Zhou, Riccardo Perfetti, Vivian FonsecaAbstract:OBJECTIVE This study assessed the efficacy and safety of LixiLan, a fixed-ratio, titratable, combination of 2 units Insulin Glargine (Gla-100) and 1 μg lixisenatide administered once daily via a single pen, versus Gla-100 in Insulin-naive type 2 diabetes on metformin. RESEARCH DESIGN AND METHODS Participants were randomized to once-daily LixiLan (n = 161) or Gla-100 (n = 162) for 24 weeks, while continuing metformin. LixiLan and Gla-100 were started at 10 units/5 μg and 10 units, respectively, and titrated based on the Gla-100 requirement according to fasting plasma glucose levels. The primary objective was to test noninferiority (upper bound of the 95% CI ≤0.4%) of LixiLan in reducing HbA1c; if met, statistical superiority was tested. Secondary objectives included body weight changes, hypoglycemia, and safety. RESULTS Baseline characteristics (mean age 57 years, diabetes duration 6–7 years, BMI 32 kg/m2) were similar between groups. At week 24, mean HbA1c was reduced from 8.0% (64 mmol/mol) at baseline to 6.3% (45 mmol/mol) and 6.5% (48 mmol/mol) with LixiLan and Gla-100, respectively, establishing statistical noninferiority and superiority of LixiLan (least-squared mean [95% CI] difference: −0.17% [−0.31, −0.04] {−1.9 mmol/mol [−3.4, −0.4]}; P = 0.01). HbA1c CONCLUSIONS LixiLan achieved statistically significant reductions to near-normal HbA1c levels with weight loss and no increased hypoglycemic risk, compared with Insulin Glargine alone, and a low incidence of gastrointestinal adverse events in type 2 diabetes inadequately controlled on metformin.
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reduction in short acting Insulin requirement accompanies improved glycemic control with basal Insulin peglispro compared with Insulin Glargine in patients with type 1 diabetes
Journal of Diabetes, 2016Co-Authors: Julio Rosenstock, Thomas Blevins, Linda Morrow, Yongming Qu, Richard M. Bergenstal, Scott J. JacoberAbstract:Keywords: hypoglycemia; Insulin Glargine; Insulin peglispro; short-acting Insulin; type 1 diabetes mellitus
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similar efficacy and safety of ly2963016 Insulin Glargine and Insulin Glargine lantus in patients with type 2 diabetes who were Insulin naive or previously treated with Insulin Glargine a randomized double blind controlled trial the element 2 study
Diabetes Obesity and Metabolism, 2015Co-Authors: Julio Rosenstock, Robyn K Pollom, Leodevico L. Ilag, Anuj Bhargava, P Hollander, W J Huster, J S Zielonka, Melvin J PrinceAbstract:Aims To compare the efficacy and safety of LY2963016 Insulin Glargine (LY IGlar) and the reference product (Lantus®) Insulin Glargine (IGlar) in combination with oral antihyperglycaemic medications in patients with type 2 diabetes (T2D). Methods This phase III, randomized, double-blind, 24-week study enrolled patients with T2D who were Insulin-naive [glycated haemoglobin (HbA1c) ≥7 and ≤11.0%] or previously on IGlar (HbA1c ≤11%) and treated with ≥2 oral antihyperglycaemic medications. Patients were randomized to receive once-daily LY IGlar (n = 376) or IGlar (n = 380) for 24 weeks. The primary efficacy outcome was to test the non-inferiority (0.4% and then 0.3% margin) of LY IGlar to IGlar, as measured by change in HbA1c from baseline to 24 weeks. Results Both treatment groups had similar and significant (p 0.05]. There were no treatment differences (p > 0.05) in fasting plasma glucose, proportion of patients reaching HbA1c <7% or Insulin dose at 24 weeks. Adverse events, allergic reactions, weight change, hypoglycaemia and Insulin antibodies were similar between treatment groups. Similar findings were observed in patients who were Insulin-naive or previously treated with IGlar at baseline. Conclusions Both LY IGlar and IGlar, when used in combination with oral antihyperglycaemic medications, provided effective and similar glucose control with similar safety profiles in patients with T2D.
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efficacy and safety of ly2963016 Insulin Glargine compared with Insulin Glargine lantus in patients with type 1 diabetes in a randomized controlled trial the element 1 study
Diabetes Obesity and Metabolism, 2015Co-Authors: Thomas C Blevins, Robyn K Pollom, Leodevico L. Ilag, Julio Rosenstock, W J Huster, J S Zielonka, D Dahl, Melvin J PrinceAbstract:Aims To compare the efficacy and safety of LY2963016 Insulin Glargine (LY IGlar) and the reference product (Lantus®) Insulin Glargine (IGlar) in patients with type 1 diabetes (T1D). Methods This phase III, randomized, open-label, 52-week study enrolled patients with T1D [glycated haemoglobin (HbA1c) ≤11%] being treated with basal (once-daily) and bolus Insulin. Patients were randomized to receive once-daily LY IGlar (n = 268) or IGlar (n = 267) in combination with mealtime Insulin lispro for 52 weeks. The primary efficacy outcome was to test the non-inferiority (0.4% and then 0.3% margin) of LY IGlar to IGlar as measured by change in HbA1c from baseline to 24 weeks. Results Both treatment groups had similar and significant (p 0.05]. There were no significant (p > 0.05) treatment differences in other efficacy measures, including proportion of patients reaching HbA1c <7%, daily mean blood glucose, and Insulin dose at 24 and 52 weeks. At 52 weeks, similar findings were observed between LY IGlar and IGlar for safety outcomes, including adverse events, allergic reactions, hypoglycaemia, weight change and Insulin antibodies. Conclusions Both LY IGlar and IGlar, when used in combination with mealtime Insulin lispro, provided effective and similar glucose control and similar safety profiles.
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Insulin degludec improves long term glycaemic control similarly to Insulin Glargine but with fewer hypoglycaemic episodes in patients with advanced type 2 diabetes on basal bolus Insulin therapy
Diabetes Obesity and Metabolism, 2015Co-Authors: Priscilla Hollander, Julio Rosenstock, Charlotte T Hansen, Allen B. King, S. Del Prato, S. Sreenan, Mustafa Kemal Balci, M. Niemeyer, Manuel Munoztorres, Alan J. GarberAbstract:The aim of the present study was to compare the long-term safety and efficacy of Insulin degludec with those of Insulin Glargine in patients with advanced type 2 diabetes (T2D) over 78 weeks (the 52-week main trial and a 26-week extension). Patients were randomized to once-daily Insulin degludec or Insulin Glargine, with mealtime Insulin aspart ± metformin ± pioglitazone, and titrated to pre-breakfast plasma glucose values of 3.9–4.9 mmol/l (70–88 mg/dl). After 78 weeks, the overall rate of hypoglycaemia was 24% lower (p = 0.011) and the rate of nocturnal hypoglycaemia was 31% lower (p = 0.016) with Insulin degludec in the extension trial set, while both groups of patients achieved similar glycaemic control. Rates of adverse events and total Insulin doses were similar for both groups in the safety analysis set. During 18 months of treatment, Insulin degludec + mealtime Insulin aspart ± oral antidiabetic drugs in patients with T2D improves glycaemic control similarly, but confers lower risks of overall and nocturnal hypoglycaemia than with Insulin Glargine treatment.
R Brodows - One of the best experts on this subject based on the ideXlab platform.
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tolerability and efficacy of exenatide and titrated Insulin Glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea a multinational randomized open label two period crossover noninferiority trial
Clinical Therapeutics, 2007Co-Authors: Anthony H Barnett, David M. Kendall, Don Johns, R Brodows, Jude Burger, Anthony P Roberts, Michael E TrautmannAbstract:Abstract Objective: This study was conducted to compare the efficacy and safety profiles of exenatide and Insulin Glargine therapy in patients with type 2 diabetes who had not achieved glucose control with metformin or sulfonylurea monotherapy. Methods: This multinational, randomized, open-label, crossover noninferiority study compared the efficacy of exenatide 10 pg BID and Insulin Glargine QD (titrated targeting a fasting serum glucose (FSG) level ≤5.6 mmol/L) in patients with type 2 diabetes treated with a single oral antidiabetic agent. The study included two 16-week treatment periods. The primary a priori outcome variable was the change in glycosylated hemoglobin (HbA lc ). Secondary outcomes included the proportion of patients achieving the American Diabetes Association (ADA) target HbA lc of ≤7% and the European Association for the Study of Diabetes target of ≤6.5%, the change in FSG, end-point values and change in the 7-point self-monitored glucose profile, and change in body weight. Adverse events were assessed based on standard laboratory tests and patient reports. Results: One hundred thirty-eight patients were randomized to study treatment (52.9% female, 47.1% male; 79.7% white; mean [SEM] age, 54.9 [0.8] years; duration of diabetes, 7.4 [0.4] years; body mass index, 31.1 [0.4] kg/m 2 ; weight, 84.8 [1.4] kg) while continuing to receive metformin (55.1%) or a sulfonylurea (44.9%). The population had a baseline least squares (LS) mean (SEM) HbA lc of 8.95% (0.09%) and an LS mean FSG concentration of 12.0 (0.3) mmol/L. Both exenatide and titrated Insulin Glargine therapy were associated with similar significant changes from baseline in HbA 1c (both, -1.36% [0.09%]; P 1c at end point was above the ADA target with both treatments (exenatide, 7.57% [0.09%]; Insulin Glargine, 7.58% [0.09%]). Similar proportions of patients achieved an HbA 1c ≤7% (37.5% and 39.8%, respectively; P = NS) or ≤6.5% (21.5% and 13.6%). Patients lost weight during exenatide treatment, whereas they gained weight during Insulin Glargine treatment; the between-group difference in weight change was statistically significant (LS mean difference, -2.2 [0.3] kg; 95% CI, -2.8 to-1.7; P P P P P P = NS). Condusions: In this open-label, crossover study, treatment with exenatide or Insulin Glargine for 16 weeks was associated with similar significant improvements from baseline in HbA 1c , independent of treatment order. The improvements in HbA 1c from baseline did not differ significantly between treatment groups. Exenatide therapy was associated with significant reductions in body weight and PPG excursions compared with Insulin Glargine, whereas Insulin Glargine was associated with a significantly greater reduction in FSG compared with exenatide. These findings provide additional information to guide treatment decisions in patients with type 2 diabetes who are potential candidates for either therapy. ( Clin Ther. 2007;29:2333-2348) Copyright © 2007 Excerpta Medica, Inc.
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exenatide versus Insulin Glargine in patients with suboptimally controlled type 2 diabetes a randomized trial
Annals of Internal Medicine, 2005Co-Authors: Robert J Heine, Luc F Van Gaal, Don Johns, Michael J Mihm, Mario Widel, R BrodowsAbstract:Background: Physicians may use either Insulin or exenatide injections for patients with type 2 diabetes mellitus who have poor glycemic control despite taking oral blood glucose-lowering drugs. Objective: To compare effects of exenatide and Insulin Glargine on glycemic control in patients with type 2 diabetes mellitus that is suboptimally controlled with metformin and a sulfonylurea. Design: 26-week multicenter, open-label, randomized, controlled trial. Setting: 82 outpatient study centers in 13 countries. Patients: 551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A 1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy. Intervention: Exenatide, 10 μg twice daily, or Insulin Glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL). Measurements: Hemoglobin A 1c level, fasting plasma glucose level, body weight, 7-point self-monitored blood glucose, standardized test-meal challenge, safety, and tolerability. Results: Baseline mean hemoglobin A 1c level was 8.2% for patients receiving exenatide and 8.3% for those receiving Insulin Glargine. At week 26, both exenatide and Insulin Glargine reduced hemoglobin A 1c levels by 1.11% (difference, 0.017 percentage point [95% Cl, -0.123 to 0.157 percentage point]). Exenatide reduced postprandial glucose excursions more than Insulin Glargine, while Insulin Glargine reduced fasting glucose concentrations more than exenatide. Body weight decreased 2.3 kg with exenatide and increased 1.8 kg with Insulin Glargine (difference, -4.1 kg [Cl, -4.6 to -3.5 kg]). Rates of symptomatic hypoglycemia were similar, but nocturnal hypoglycemia occurred less frequently with exenatide (0.9 event/patient-year versus 2.4 events/ patient-year; difference, -1.6 events/patient-year [Cl, -2.3 to -0.9 event/patient year]). Gastrointestinal symptoms were more common in the exenatide group than in the Insulin Glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%). Limitations: The trial was open-label and did not assess clinical complications related to diabetes. Of the 551 participants, 19.4% of those receiving exenatide and 9.7% of those receiving Insulin Glargine withdrew from the study. Only 21.6% of the Insulin Glargine group and 8.6% of the exenatide group achieved the target level for fasting plasma glucose of less than 5.6 mmol/L (<100 mg/dL). Conclusions: Exenatide and Insulin Glargine achieved similar improvements in overall glycemic control in patients with type 2 diabetes that was suboptimally controlled with oral combination therapy. Exenatide was associated with weight reduction and had a higher incidence of gastrointestinal adverse effects than Insulin Glargine.
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exenatide versus Insulin Glargine in patients with suboptimally controlled type 2 diabetes a randomized trial
Annals of Internal Medicine, 2005Co-Authors: Robert J Heine, Don Johns, Michael J Mihm, Mario Widel, Luc F Van Gaal, R BrodowsAbstract:Background: Physicians may use either Insulin or exenatide injections for patients with type 2 diabetes mellitus who have poor glycemic control despite taking oral blood glucose-lowering drugs. Objective: To compare effects of exenatide and Insulin Glargine on glycemic control in patients with type 2 diabetes mellitus that is suboptimally controlled with metformin and a sulfonylurea. Design: 26-week multicenter, open-label, randomized, controlled trial. Setting: 82 outpatient study centers in 13 countries. Patients: 551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A 1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy. Intervention: Exenatide, 10 μg twice daily, or Insulin Glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL). Measurements: Hemoglobin A 1c level, fasting plasma glucose level, body weight, 7-point self-monitored blood glucose, standardized test-meal challenge, safety, and tolerability. Results: Baseline mean hemoglobin A 1c level was 8.2% for patients receiving exenatide and 8.3% for those receiving Insulin Glargine. At week 26, both exenatide and Insulin Glargine reduced hemoglobin A 1c levels by 1.11% (difference, 0.017 percentage point [95% Cl, -0.123 to 0.157 percentage point]). Exenatide reduced postprandial glucose excursions more than Insulin Glargine, while Insulin Glargine reduced fasting glucose concentrations more than exenatide. Body weight decreased 2.3 kg with exenatide and increased 1.8 kg with Insulin Glargine (difference, -4.1 kg [Cl, -4.6 to -3.5 kg]). Rates of symptomatic hypoglycemia were similar, but nocturnal hypoglycemia occurred less frequently with exenatide (0.9 event/patient-year versus 2.4 events/ patient-year; difference, -1.6 events/patient-year [Cl, -2.3 to -0.9 event/patient year]). Gastrointestinal symptoms were more common in the exenatide group than in the Insulin Glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%). Limitations: The trial was open-label and did not assess clinical complications related to diabetes. Of the 551 participants, 19.4% of those receiving exenatide and 9.7% of those receiving Insulin Glargine withdrew from the study. Only 21.6% of the Insulin Glargine group and 8.6% of the exenatide group achieved the target level for fasting plasma glucose of less than 5.6 mmol/L (<100 mg/dL). Conclusions: Exenatide and Insulin Glargine achieved similar improvements in overall glycemic control in patients with type 2 diabetes that was suboptimally controlled with oral combination therapy. Exenatide was associated with weight reduction and had a higher incidence of gastrointestinal adverse effects than Insulin Glargine.
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exenatide versus Insulin Glargine in patients with suboptimally controlled type 2 diabetes
Annals of Internal Medicine, 2005Co-Authors: Robert J Heine, Luc F Van Gaal, Don Johns, Michael J Mihm, Mario Widel, R BrodowsAbstract:Exenatide mimics a polypeptide hormone that coordinates Insulin release with ingestion of food. The authors compared glycemic control with exenatide or Insulin Glargine. After 26 weeks, both exenat...
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exenatide versus Insulin Glargine in patients with suboptimally controlled type 2 diabetes a randomized trial
Annals of Internal Medicine, 2005Co-Authors: Robert J Heine, Luc F Van Gaal, Don Johns, Michael J Mihm, Mario Widel, R BrodowsAbstract:Exenatide mimics a polypeptide hormone that coordinates Insulin release with ingestion of food. The authors compared glycemic control with exenatide or Insulin Glargine. After 26 weeks, both exenat...
Robert J Heine - One of the best experts on this subject based on the ideXlab platform.
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one year treatment with exenatide vs Insulin Glargine effects on postprandial glycemia lipid profiles and oxidative stress
Atherosclerosis, 2010Co-Authors: Mathijs C Bunck, Hannele Ykijarvinen, Robert J Heine, Anja Corner, Bjorn Eliasson, Rimma M Shaginian, Ulf Smith, Ping Yan, Michaela DiamantAbstract:Abstract Objective The objective of the present study was to investigate the effects of one-year treatment with exenatide or Insulin Glargine, followed by a 5-week off-drug period, on postprandial lipidaemia, glycaemia and measures of oxidative stress. Methods Sixty-nine metformin-treated patients with type 2 diabetes were randomised (using apermuted block randomisation scheme stratified by site and baseline HbA 1c stratum (≤8.5% or >8.5%) of which 60 completed (exenatide n =30; Insulin Glargine n =30) the pre-treatment and on-drug meal test. Postprandial glucose, lipids and lipoproteins, and oxidative stress markers were studied at week −1, 51, and after a 5-week off-drug period following a breakfast and lunch mixed-meal containing 50g fat, 75g carbohydrates, and 35g protein. Results 51-Week exenatide treatment resulted in a significant reduction of prandial glucose, triglycerides, apo-B48, calculated VLDL-C, FFA and MDA excursions whereas Insulin Glargine predominantly reduced fasting glucose, FFA and MDA. Changes in markers of oxidative stress were related to changes in postprandial glucose and triglyceride excursions, independent of treatment arm. All postprandial measures returned to pre-treatment values in both groups after 5-week cessation of study treatment. Conclusion Exenatide showed beneficial effects on postprandial glycaemia and lipidaemia, and these effects were related to changes in the oxidative stress markers MDA and oxLDL during one year of treatment as compared to Insulin Glargine. Following cessation of both exenatide and Insulin Glargine measures returned to pre-treatment values, suggesting that ongoing treatment is necessary to maintain the beneficial effects of either therapy.
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exenatide versus Insulin Glargine in patients with suboptimally controlled type 2 diabetes a randomized trial
Annals of Internal Medicine, 2005Co-Authors: Robert J Heine, Luc F Van Gaal, Don Johns, Michael J Mihm, Mario Widel, R BrodowsAbstract:Background: Physicians may use either Insulin or exenatide injections for patients with type 2 diabetes mellitus who have poor glycemic control despite taking oral blood glucose-lowering drugs. Objective: To compare effects of exenatide and Insulin Glargine on glycemic control in patients with type 2 diabetes mellitus that is suboptimally controlled with metformin and a sulfonylurea. Design: 26-week multicenter, open-label, randomized, controlled trial. Setting: 82 outpatient study centers in 13 countries. Patients: 551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A 1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy. Intervention: Exenatide, 10 μg twice daily, or Insulin Glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL). Measurements: Hemoglobin A 1c level, fasting plasma glucose level, body weight, 7-point self-monitored blood glucose, standardized test-meal challenge, safety, and tolerability. Results: Baseline mean hemoglobin A 1c level was 8.2% for patients receiving exenatide and 8.3% for those receiving Insulin Glargine. At week 26, both exenatide and Insulin Glargine reduced hemoglobin A 1c levels by 1.11% (difference, 0.017 percentage point [95% Cl, -0.123 to 0.157 percentage point]). Exenatide reduced postprandial glucose excursions more than Insulin Glargine, while Insulin Glargine reduced fasting glucose concentrations more than exenatide. Body weight decreased 2.3 kg with exenatide and increased 1.8 kg with Insulin Glargine (difference, -4.1 kg [Cl, -4.6 to -3.5 kg]). Rates of symptomatic hypoglycemia were similar, but nocturnal hypoglycemia occurred less frequently with exenatide (0.9 event/patient-year versus 2.4 events/ patient-year; difference, -1.6 events/patient-year [Cl, -2.3 to -0.9 event/patient year]). Gastrointestinal symptoms were more common in the exenatide group than in the Insulin Glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%). Limitations: The trial was open-label and did not assess clinical complications related to diabetes. Of the 551 participants, 19.4% of those receiving exenatide and 9.7% of those receiving Insulin Glargine withdrew from the study. Only 21.6% of the Insulin Glargine group and 8.6% of the exenatide group achieved the target level for fasting plasma glucose of less than 5.6 mmol/L (<100 mg/dL). Conclusions: Exenatide and Insulin Glargine achieved similar improvements in overall glycemic control in patients with type 2 diabetes that was suboptimally controlled with oral combination therapy. Exenatide was associated with weight reduction and had a higher incidence of gastrointestinal adverse effects than Insulin Glargine.
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exenatide versus Insulin Glargine in patients with suboptimally controlled type 2 diabetes a randomized trial
Annals of Internal Medicine, 2005Co-Authors: Robert J Heine, Don Johns, Michael J Mihm, Mario Widel, Luc F Van Gaal, R BrodowsAbstract:Background: Physicians may use either Insulin or exenatide injections for patients with type 2 diabetes mellitus who have poor glycemic control despite taking oral blood glucose-lowering drugs. Objective: To compare effects of exenatide and Insulin Glargine on glycemic control in patients with type 2 diabetes mellitus that is suboptimally controlled with metformin and a sulfonylurea. Design: 26-week multicenter, open-label, randomized, controlled trial. Setting: 82 outpatient study centers in 13 countries. Patients: 551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A 1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy. Intervention: Exenatide, 10 μg twice daily, or Insulin Glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL). Measurements: Hemoglobin A 1c level, fasting plasma glucose level, body weight, 7-point self-monitored blood glucose, standardized test-meal challenge, safety, and tolerability. Results: Baseline mean hemoglobin A 1c level was 8.2% for patients receiving exenatide and 8.3% for those receiving Insulin Glargine. At week 26, both exenatide and Insulin Glargine reduced hemoglobin A 1c levels by 1.11% (difference, 0.017 percentage point [95% Cl, -0.123 to 0.157 percentage point]). Exenatide reduced postprandial glucose excursions more than Insulin Glargine, while Insulin Glargine reduced fasting glucose concentrations more than exenatide. Body weight decreased 2.3 kg with exenatide and increased 1.8 kg with Insulin Glargine (difference, -4.1 kg [Cl, -4.6 to -3.5 kg]). Rates of symptomatic hypoglycemia were similar, but nocturnal hypoglycemia occurred less frequently with exenatide (0.9 event/patient-year versus 2.4 events/ patient-year; difference, -1.6 events/patient-year [Cl, -2.3 to -0.9 event/patient year]). Gastrointestinal symptoms were more common in the exenatide group than in the Insulin Glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%). Limitations: The trial was open-label and did not assess clinical complications related to diabetes. Of the 551 participants, 19.4% of those receiving exenatide and 9.7% of those receiving Insulin Glargine withdrew from the study. Only 21.6% of the Insulin Glargine group and 8.6% of the exenatide group achieved the target level for fasting plasma glucose of less than 5.6 mmol/L (<100 mg/dL). Conclusions: Exenatide and Insulin Glargine achieved similar improvements in overall glycemic control in patients with type 2 diabetes that was suboptimally controlled with oral combination therapy. Exenatide was associated with weight reduction and had a higher incidence of gastrointestinal adverse effects than Insulin Glargine.
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exenatide versus Insulin Glargine in patients with suboptimally controlled type 2 diabetes
Annals of Internal Medicine, 2005Co-Authors: Robert J Heine, Luc F Van Gaal, Don Johns, Michael J Mihm, Mario Widel, R BrodowsAbstract:Exenatide mimics a polypeptide hormone that coordinates Insulin release with ingestion of food. The authors compared glycemic control with exenatide or Insulin Glargine. After 26 weeks, both exenat...
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exenatide versus Insulin Glargine in patients with suboptimally controlled type 2 diabetes a randomized trial
Annals of Internal Medicine, 2005Co-Authors: Robert J Heine, Luc F Van Gaal, Don Johns, Michael J Mihm, Mario Widel, R BrodowsAbstract:Exenatide mimics a polypeptide hormone that coordinates Insulin release with ingestion of food. The authors compared glycemic control with exenatide or Insulin Glargine. After 26 weeks, both exenat...
Andreas Fritsche - One of the best experts on this subject based on the ideXlab platform.
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reduced hypoglycemia risk with Insulin Glargine a meta analysis comparing Insulin Glargine with human nph Insulin in type 2 diabetes
Diabetes Care, 2005Co-Authors: Julio Rosenstock, George Dailey, Massimo Massibenedetti, Andreas Fritsche, Zhengning Lin, Alan SalzmanAbstract:OBJECTIVE —Insulin Glargine (LANTUS) is a once-daily basal Insulin analog with a smooth 24-h time-action profile that provides effective glycemic control with reduced hypoglycemia risk (particularly nocturnal) compared with NPH Insulin in patients with type 2 diabetes. A recent “treat-to-target” study has shown that more patients on Insulin Glargine reached HbA 1c levels ≤7.0% without confirmed nocturnal hypoglycemia compared with NPH Insulin. We further assessed the risk for hypoglycemia in a meta-analysis of controlled trials of a similar design for Insulin Glargine versus once- or twice-daily NPH Insulin in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS —All studies were 24–28 weeks long, except one 52-week study, for which interim 20-week data were used. RESULTS —Patient demographics were similar between the Insulin Glargine ( n = 1,142) and NPH Insulin ( n = 1,162) groups. The proportion of patients achieving target HbA 1c (≤7.0%) was similar between Insulin Glargine–and NPH Insulin–treated patients (30.8 and 32.1%, respectively). There was a consistent significant reduction of hypoglycemia risk associated with Insulin Glargine, compared with NPH Insulin, in terms of overall symptomatic (11%; P = 0.0006) and nocturnal (26%; P P = 0.0442) and 59% ( P = 0.0231), respectively. CONCLUSIONS —These results confirmed that Insulin Glargine given once daily reduces the risk of hypoglycemia compared with NPH Insulin, which can facilitate more aggressive Insulin treatment to a HbA 1c target of ≤7.0% in patients with type 2 diabetes.
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glimepiride combined with morning Insulin Glargine bedtime neutral protamine hagedorn Insulin or bedtime Insulin Glargine in patients with type 2 diabetes a randomized controlled trial
Annals of Internal Medicine, 2003Co-Authors: Andreas Fritsche, Matthias Axel Schweitzer, Hansulrich HaringAbstract:Background: Patients with type 2 diabetes are often treated with oral antidiabetic agents plus a basal Insulin. Objective: To investigate the efficacy and safety of glimepiride combined with either morning or bedtime Insulin Glargine or bedtime neutral protamine Hagedorn (NPH) Insulin in patients with type 2 diabetes. Design: Open-label, randomized, controlled trial. Setting: 111 centers in 13 European countries. Patients: 695 patients with type 2 diabetes who were previously treated with oral antidiabetic agents. Intervention: Randomization to treatment with morning Insulin Glargine, bedtime NPH Insulin, or bedtime Insulin Glargine for 24 weeks in addition to 3 mg of glimepiride. The Insulin dose was titrated by using a predefined regimen to achieve fasting blood glucose levels of 5.56 mmol/L or lower (≤100 mg/dL). Measurements: Hemoglobin A 1c values, blood glucose levels, Insulin dose, and body weight. Results: Hemoglobin A 1c levels improved by -1.24% (two-sided 90% CI, -1.10% to -1.38%) with morning Insulin Glargine, by -0.96% (Cl, -0.81% to -1.10%) with bedtime Insulin Glargine, and by -0.84% (Cl, -0.69% to -0.98%) with bedtime NPH Insulin. Hemoglobin A 1c improvement was more pronounced with morning Insulin Glargine than with NPH Insulin (0.40% [Cl, 0.23% to 0.58%]; P = 0.001) or bedtime Insulin Glargine (0.28% [Cl, 0.11% to 0.46%]; P = 0.008). Baseline to end-point fasting blood glucose levels improved similarly in all three groups. Nocturnal hypoglycemia was less frequent with morning (39 of 236 patients [17%]) and bedtime Insulin Glargine (52 of 227 patients [23%]) than with bedtime NPH Insulin (89 of 232 patients [38%]) (P < 0.001). Conclusion: The risk for nocturnal hypoglycemia was lower with glimepiride in combination with morning and bedtime Insulin Glargine than with glimepiride in combination with bedtime NPH Insulin in patients with type 2 diabetes. Morning Insulin Glargine provided better glycemic control than did bedtime Insulin Glargine or bedtime NPH Insulin.
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glimepiride combined with morning Insulin Glargine bedtime neutral protamine hagedorn Insulin or bedtime Insulin Glargine in patients with type 2 diabetes
Annals of Internal Medicine, 2003Co-Authors: Andreas Fritsche, Matthias Axel Schweitzer, Hansulrich HringAbstract:In patients taking glimepiride for type 2 diabetes, the risk for nocturnal hypoglycemia was lower with morning or bedtime Insulin Glargine than with bedtime neutral protamine Hagedorn (NPH) Insulin...
Hansulrich Hring - One of the best experts on this subject based on the ideXlab platform.
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glimepiride combined with morning Insulin Glargine bedtime neutral protamine hagedorn Insulin or bedtime Insulin Glargine in patients with type 2 diabetes
Annals of Internal Medicine, 2003Co-Authors: Andreas Fritsche, Matthias Axel Schweitzer, Hansulrich HringAbstract:In patients taking glimepiride for type 2 diabetes, the risk for nocturnal hypoglycemia was lower with morning or bedtime Insulin Glargine than with bedtime neutral protamine Hagedorn (NPH) Insulin...