A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial

• Type of Material: Article
• Authors: Guillermo Umpierrez, Emory University; Saumeth Cardona, Emory University; David Chachkhiani, Emory University; Maya Fayfman, Emory University; Sahebi Saiyed, Emory University; Heqiong Wang, Emory University; Priyathama Vellanki, Emory University; J. Sonya Haw, Emory University; Darin Olson, Emory University; Francisco Javier Pasquel, Emory University; Theodore M Johnson II, Emory University
• Language: English
• Date: 2018-05-01
• Publisher: Elsevier
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jamda.2017.11.002
• Title of Journal or Parent Work: Journal of the American Medical Directors Association
• ISSN: 1525-8610
• Volume: 19
• Issue: 5
• Start Page: 399
• End Page: +
• Grant/Funding Information: Linagliptin was kindly provided by Boehringer Ingelheim.; F.J.P. has received consulting fees from Merck and Boehringer Ingelheim.; P.V. is supported by NIH grant 3K12HD085850-03S1.; This investigator-initiated study was supported by a clinical research grant from the American Diabetes Association (1-14-LLY-36).; G.E.U. is partly supported by research grants from the NIH/NATS UL1 TR002378 from the Clinical and Translational Science Award program; and 1P30DK111024-01 from the National Institutes of Health and National Center for Research Resources.; G.E.U. has also received unrestricted research support for inpatient studies (to Emory University) from Sanofi, Merck, Novo Nordisk, AstraZeneca, and Boehringer Ingelheim.
• Keywords: SURGERY PATIENTS; Geriatrics & Gerontology; HOME PATIENTS; ELDERLY-PATIENTS; INCRETIN-BASED THERAPY; skilled nursing facilities; Science & Technology; long-term care; DPP4 inhibitors; hospital hyperglycemia; older adults; GLYCEMIC VARIABILITY; MELLITUS; linagliptin; diabetes; Incretin; HOSPITALIZED-PATIENTS; nursing home; GENERAL MEDICINE; basal insulin; INPATIENT MANAGEMENT; glargine; COMPLICATIONS; Life Sciences & Biomedicine
• Research Categories: Health Sciences, Public Health; Health Sciences, Medicine and Surgery

Abstract

Objectives: Safe and easily implemented treatment regimens are needed for the management of patients with type 2 diabetes mellitus (T2DM) in long-term care (LTC) and skilled nursing facilities. Design: This 6-month open-label randomized controlled trial compared the efficacy and safety of a DPP4 inhibitor (linagliptin) and basal insulin (glargine) in LTC residents with T2DM. Settings: Three LTC institutions affiliated with a community safety-net hospital, US Department of Veterans Affairs and Emory Healthcare System in Atlanta, Georgia. Participants: A total of 140 residents with T2DM treated with oral antidiabetic agents or low-dose insulin (≤0.1 U/kg/d), with fasting or premeal blood glucose (BG) > 180 mg/dL and/or HbA1c >7.5%. Intervention: Baseline antidiabetic therapy, except metformin, was discontinued on trial entry. Residents were treated with linagliptin 5 mg/d (n = 67) or glargine at a starting dose of 0.1 U/kg/d (n = 73). Both groups received supplemental rapid-acting insulin before meals for BG > 200 mg/dL. Measurements: Primary outcome was mean difference in daily BG between groups. Main secondary endpoints included differences in frequency of hypoglycemia, glycosylated hemoglobin (HbA1c), complications, emergency department visits, and hospital transfers. Results: Treatment with linagliptin resulted in no significant differences in mean daily BG (146 ± 34 mg/dL vs. 157 ± 36 mg/dL, P =.07) compared to glargine. Linagliptin treatment resulted in fewer mild hypoglycemic events <70 mg/dL (3% vs. 37%, P <.001), but there were no differences in BG < 54 mg/dL (P =.06) or <40 mg/dL (P =.05) compared to glargine. There were no significant between-group differences in HbA1c, length of stay, complications, emergency department visits, or hospitalizations. Conclusion: Treatment with linagliptin resulted in noninferior glycemic control and in significantly lower risk of hypoglycemia compared to insulin glargine in long-term care and skilled nursing facility residents with type 2 diabetes.