دورية أكاديمية
Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial
| العنوان: | Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial |
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| المؤلفون: | Lingvay, Ildiko, Manghi, Federico Perez, García-Hernández, Pedro, Norwood, Paul, Lehmann, Lucine, Tarp-Johansen, Mads Jeppe, Buse, John B. |
| المصدر: | JAMA - The Journal of the American Medical Association, 315(9) |
| سنة النشر: | 2016 |
| المجموعة: | Carolina Digital Repository (UNC - University of North Carolina) |
| مصطلحات موضوعية: | Middle Aged, Weight Gain, Hypoglycemic Agents, Female, Hemoglobin A, Glycosylated, Insulin Glargine, insulin degludec, Metformin, Diabetes Mellitus, Type 2, Weight Loss, Male, Insulin, Long-Acting, Humans, Hypoglycemia |
| الوصف: | Achieving glycemic control remains a challenge for patients with type 2 diabetes, even with insulin therapy. To assess whether a fixed ratio of insulin degludec/liraglutide was noninferior to continued titration of insulin glargine in patients with uncontrolled type 2 diabetes treated with insulin glargine and metformin. Phase 3, multinational, multicenter, 26-week, randomized, open-label, 2-group, treat-to-target trial conducted at 75 centers in 10 countries from September 2013 to November 2014 among 557 patients with uncontrolled diabetes treated with glargine (20-50 U) and metformin (≥1500 mg/d) with glycated hemoglobin (HbA1c) levels of 7% to 10% and a body mass index of 40 or lower. 1:1 randomization to degludec/liraglutide (n = 278; maximum dose, 50 U of degludec/1.8 mg of liraglutide) or glargine (n = 279; no maximum dose), with twice-weekly titration to a glucose target of 72 to 90 mg/dL. Primary outcome measure was change in HbA1c level after 26 weeks, with a noninferiority margin of 0.3% (upper bound of 95% CI, <0.3%). If noninferiority of degludec/liraglutide was achieved, secondary end points were tested for statistical superiority and included change in HbA1c level, change in body weight, and rate of confirmed hypoglycemic episodes. Among 557 randomized patients (mean: age, 58.8 years; women, 49.7%), 92.5% of patients completed the trial and provided data at 26 weeks. Baseline HbA1c level was 8.4% for the degludec/liraglutide group and 8.2% for the glargine group. HbA1c level reduction was greater with degludec/liraglutide vs glargine (-1.81% for the degludec/liraglutide group vs -1.13% for the glargine group; estimated treatment difference [ETD], -0.59% [95% CI, -0.74% to -0.45%]), meeting criteria for noninferiority (P < .001), and also meeting criteria for statistical superiority (P < .001). Treatment with degludec/liraglutide was also associated with weight loss compared with weight gain with glargine (-1.4 kg for degludec/liraglutide vs 1.8 kg for glargine; ETD, -3.20 kg [95% CI, -3.77 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://doi.org/10.17615/ap66-xf68Test; https://cdr.lib.unc.edu/downloads/rx913v699?file=thumbnailTest; https://cdr.lib.unc.edu/downloads/rx913v699Test |
| DOI: | 10.17615/ap66-xf68 |
| الإتاحة: | https://doi.org/10.17615/ap66-xf68Test https://cdr.lib.unc.edu/downloads/rx913v699?file=thumbnailTest https://cdr.lib.unc.edu/downloads/rx913v699Test |
| حقوق: | http://rightsstatements.org/vocab/InC/1.0Test/ |
| رقم الانضمام: | edsbas.16FB863A |
| قاعدة البيانات: | BASE |
| DOI: | 10.17615/ap66-xf68 |
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