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.

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.

• Authors: Guillermo E Umpierrez, Saumeth Cardona, David Chachkhiani, Maya Fayfman, Sahebi Saiyed, Heqiong Wang, Priyathama Vellanki, J Sonya Haw, Darin E Olson, Francisco J Pasquel, Theodore M Johnson 2nd
• Journal: Journal of the American Medical Directors Association (J Am Med Dir Assoc) Vol. 19 Issue 5 Pg. 399-404.e3 (05 2018) ISSN: 1538-9375 [Electronic] United States
• PMID: 29289540 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.

Chemical References

• Blood Glucose
• Dipeptidyl-Peptidase IV Inhibitors
• Glycated Hemoglobin A
• Hypoglycemic Agents
• hemoglobin A1c protein, human
• Insulin Glargine
• Linagliptin

Topics

• Aged
• Blood Glucose (analysis)
• Diabetes Mellitus, Type 2 (drug therapy)
• Dipeptidyl-Peptidase IV Inhibitors (therapeutic use)
• Female
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemia (etiology)
• Hypoglycemic Agents (therapeutic use)
• Insulin Glargine (therapeutic use)
• Linagliptin (therapeutic use)
• Male
• Residential Facilities
• Skilled Nursing Facilities