A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial

• Type of Material: Article
• Authors: Francisco Pasquel, Emory University; Cecilia Lansang, The Cleveland Clinic Foundation; Ameer Khowaja, University of Minnesota, Minneapolis; Agustina M Urrutia, Emory University; Saumeth Cardona, Emory University; Bonnie Albury, Emory University; Rodolfo Galindo, Emory University; Maya Fayfman, Emory University; Georgia Davis, Emory University; Alexandra Migdal, Emory University; Priyathama Vellanki, Emory University; Limin Peng, Emory University; Guillermo Umpierrez, Emory University
• Language: English
• Date: 2020-06-01
• Publisher: AMER DIABETES ASSOC
• Publication Version: Final Published Version
• Copyright Statement: © 2020 by the American Diabetes Association
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.2337/dc19-1940
• Title of Journal or Parent Work: DIABETES CARE
• Volume: 43
• Issue: 6
• Start Page: 1242
• End Page: 1248
• Grant/Funding Information: The funding source was not involved in the study design, data collection, interpretation, statistical analysis, manuscript preparation, or the decision to submit the manuscript for publication.; This study was an investigator-initiated study funded by Sanofi. The terms of this arrangement were reviewed and approved by Emory University in accordance with its conflict of interest policies. F.J.P. is partially supported by National Institutes of Health (NIH) grant 1K23GM128221-01A1 and has received research support from Merck and Dexcom and consulting fees from Sanofi, Merck, Boehringer Ingelheim, Lilly, and AstraZeneca. P.V. is partially supported by NIH grant 1K23DK113241-01A1 and has received consulting fees from Boehringer Ingelheim and Merck. R.J.G. is partially supported by NIH grant P30DK11102 and has received research grants from Novo Nordisk (to Emory University) and consulting fees from Abbott Diabetes, Sanofi, Novo Nordisk, and Valeritas. G.E.U. is partially supported by NIH grants UL1TR002378 and 1P30DK111024-01 and has received unrestricted research support for inpatient studies (to Emory University) from Novo Nordisk, Sanofi, and Dexcom. No other potential conflicts of interest relevant to this article were reported.
• Keywords: Life Sciences & Biomedicine; GLUCOSE CONTROL; HYPOGLYCEMIA; CRITICALLY-ILL; GLYCEMIC CONTROL; MORTALITY; 300 U/ML; PEOPLE; INSULIN THERAPY; Science & Technology; BASAL INSULIN; Endocrinology & Metabolism; HYPERGLYCEMIA
• Research Categories: Health Sciences, Public Health

Abstract

OBJECTIVE The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D. RESEARCH DESIGN AND METHODS This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA1c 9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 (n = 92) or glargine U100 (n = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70–180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia. RESULTS There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70–180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74). There were no differences in the proportion of patients with BG <70 mg/dL (8.7% vs. 9.5%, P > 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia (<54 mg/dL) compared with glargine U100 (0% vs. 6.0%, P = 0.023). CONCLUSIONS Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.