Basal-Bolus Regimen With Insulin Analogues Versus Human Insulin in Medical Patients with type 2 Diabetes: A Randomized Controlled Trial in Latin America |
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| Affiliation: | 1. From the Department of Medicine, Hospital de Clínicas, Universidad Nacional de Asunción, Asunción, Paraguay;2. Department of Medicine, Emory University, Atlanta, Georgia.;1. From the Weill Cornell Medical College, Division of Endocrinology, Diabetes and Metabolism, Houston Methodist Hospital System;2. Main Line Health System, University of Pennsylvania;3. Department of Biology and Molecular Biology, Montclair State University, Montclair, New Jersey.;1. From the Department of Surgical Oncology;2. Department of Endocrine Neoplasia and Hormonal Disorders;3. Department of Diagnostic Radiology;4. Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.;1. Department of Medicine, Emory University, Atlanta, GA;2. Rollins School of Public Health, Emory University, Atlanta, GA;3. Center for Comprehensive Informatics, Emory University, Atlanta, GA;4. Joseph B. Whitehead Department of Surgery, Atlanta, GA;5. Emory University, Atlanta, GA |
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| Abstract: | Objective: Few randomized studies have focused on the optimal management of non–intensive care unit patients with type 2 diabetes in Latin America. We compared the safety and efficacy of a basal-bolus regimen with analogues and human insulins in general medicine patients admitted to a University Hospital in Asunción, Paraguay.Methods: In a prospective, open-label trial, we randomized 134 nonsurgical patients with blood glucose (BG) between 140 and 400 mg/dL to a basal-bolus regimen with glargine once daily and glulisine before meals (n = 66) or Neutral Protamine Hagedorn (NPH) twice daily and regular insulin before meals (n = 68). Major outcomes included differences in daily BG levels and frequency of hypoglycemic events between treatment groups.Results: There were no differences in the mean daily BG (157 ± 37 mg/dL versus 158 ± 44 mg/dL; P = .90) or in the number of BG readings within target <140 mg/dL before meals (76% versus 74%) between the glargine/glulisine and NPH/regular regimens. The mean insulin dose in the glargine/glulisine group was 0.76 ± 0.3 units/kg/day (glargine, 22 ± 9 units/day; glulisine, 31 ± 12 units/day) and was not different compared with NPH/regular group (0.75 ± 0.3 units/kg/day [NPH, 28 ± 12 units/day; regular, 23 ± 9 units/day]). The overall prevalence of hypoglycemia (<70 mg/dL) was similar between patients treated with NPH/regular and glargine/glulisine (38% versus 35%; P = .68), but more patients treated with human insulin had severe (<40 mg/dL) hypoglycemia (7.6% versus 25%; P = .08). There were no differences in length of hospital stay or mortality between groups.Conclusion: The basal-bolus regimen with insulin analogues resulted in equivalent glycemic control and frequency of hypoglycemia compared to treatment with human insulin in hospitalized patients with diabetes.Abbreviations: BG = blood glucose BMI = body mass index HbA1c = glycated hemoglobin NPH = Neutral Protamine Hagedorn T2D = type 2 diabetes |
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