A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities.

• Type of Material: Article
• Authors: Francisco J Pasquel, Emory University; Winter Powell, Emory University; Limin Peng, Emory University; Theodore Johnson II, Emory University; Shadi Sadeghi-Yarandi, Emory University; Christopher Newton, Emory University; Dawn Smiley, Emory University; Marcos T Toyoshima, Emory University; Pedram Aram, Emory University; Guillermo Umpierrez, Emory University
• Language: English
• Date: 2015-08
• Publisher: BMJ Publishing Group: Open Access
• Publication Version: Final Published Version
• Copyright Statement: © 2015 by the BMJ Publishing Group Ltd.
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1136/bmjdrc-2015-000104
• Title of Journal or Parent Work: BMJ Open Diabetes Research and Care
• ISSN: 2052-4897
• Volume: 3
• Issue: 1
• Start Page: e000104
• End Page: e000104
• Grant/Funding Information: This investigator-initiated study was supported by an unrestricted grant from Sanofi Aventis (Bridgewater, New Jersey, USA) to Emory University.; DS has received research support (to Emory University) from Abbott, Merck, and Sanofi, and has received fees or/and honoraria for participation in advisory committees from Janssen, Sanofi and Boehringer Ingelheim.; GEU is supported in part by research grants from the American Diabetes Association (1-14-LLY-36), PHS grant UL1 RR025008 from the Clinical Translational Science Award Program (M01 RR-00039), has received unrestricted research support for inpatient studies (to Emory University) from Sanofi, Merck, Novo Nordisk, Boehringer Ingelheim and has received consulting fees or/and honoraria for participation in advisory boards from Novo Nordisk, Regeneron, Sanofi, Merck and Boehringer Ingelheim.
• Keywords: Hyperglycemia; Elderly; Hypoglycemia; Insulin
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Public Health

Abstract

BACKGROUND: Managing hyperglycemia and diabetes is challenging in geriatric patients admitted to long-term care (LTC) facilities. METHODS: This randomized control trial enrolled patients with type 2 diabetes (T2D) with blood glucose (BG) >180 mg/dL or glycated hemoglobin >7.5% to receive low-dose basal insulin (glargine, starting dose 0.1 U/kg/day) or oral antidiabetic drug (OAD) therapy as per primary care provider discretion for 26 weeks. Both groups received supplemental rapid-acting insulin before meals for BG >200 mg/dL. Primary end point was difference in glycemic control as measured by fasting and mean daily glucose concentration between groups. RESULTS: A total of 150 patients (age: 79±8 years, body mass index: 30.1±6.5 kg/m(2), duration of diabetes mellitus: 8.2±5.1 years, randomization BG: 194±97 mg/dL) were randomized to basal insulin (n=75) and OAD therapy (n=75). There were no differences in the mean fasting BG (131±27 mg/dL vs 123±23 mg/dL, p=0.06) between insulin and OAD groups, but patients treated with insulin had greater mean daily BG (163±39 mg/dL vs 138±27 mg/dL, p<0.001) compared to those treated with OADs. There were no differences in the rate of hypoglycemia (<70 mg/dL) between insulin (27%) and OAD (31%) groups, p=0.58. In addition, there were no differences in the number of hospital complications, emergency room visits, and mortality between treatment groups. CONCLUSIONS: The results of this randomized study indicate that elderly patients with T2D in LTC facilities exhibited similar glycemic control, hypoglycemic events and complications when treated with either basal insulin or with oral antidiabetic drugs. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01131052.