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.
Keywords
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Article info
Publication history
Published online: December 27, 2017
Footnotes
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. P.V. is supported by NIH grant 3K12HD085850-03S1. G.E.U. has also received unrestricted research support for inpatient studies (to Emory University) from Sanofi, Merck, Novo Nordisk, AstraZeneca, and Boehringer Ingelheim. F.J.P. has received consulting fees from Merck and Boehringer Ingelheim. No other potential conflict of interest relevant to this article was reported.
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© 2017 AMDA - The Society for Post-Acute and Long-Term Care Medicine.
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- ErratumJournal of the American Medical Directors AssociationVol. 20Issue 7
- PreviewThe Authors wish to make a correction to their article published in JAMDA ( https://doi.org/10.1016/j.jamda.2017.11.002 ) “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”.
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