ADA Linagliptin in Long Term Care

A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes

This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: insulin glargine; Drug: linagliptin

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30315
      • Crestvew Nursing Home
    • Atlanta, Georgia, United States, 30322
      • Budd Terrace Nursing Home
    • Atlanta, Georgia, United States, 30322
      • Wesley Woods Nursing Home
    • Decatur, Georgia, United States, 30033
      • VA Nursing Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
2. Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

Exclusion Criteria:

1. Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
2. Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
3. Recurrent severe hypoglycemia or hypoglycemic unawareness.
4. Subjects with history of gastrointestinal obstruction or gastroparesis.
5. Patients with acute or chronic pancreatitis or pancreatic cancer.
6. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 45 ml/min).
7. Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
8. Mental condition rendering the subject unable to understand the nature and scope of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin glargine; Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.	Drug: insulin glargine; Other Names: Lantus
Experimental: linagliptin; Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.	Drug: linagliptin; 5mg linagliptin tablets; Other Names: Tradjenta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Fasting Blood Glucose Level	The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c at 6 month	6 months
Number of Hypoglycemic Events < 70mg/dl	total number of hypoglycemic events (<70 mg/dl)	over 6 months
Number of Hypoglycemic Events < 40mg/dl	total number of severe hypoglycemia (< 40 mg/dl).	over 6 months
Total Daily Dose of Insulin	Total daily dose of insulin (units)	over 6 months
Changes in Cognitive Function	Data on changes in cognitive function were not collected	over 6 months
Number of Participants With Acute Complications	Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).	over 6 months
Total Number of Emergency Room Visits	Total number of emergency room visits during the study period	6 months
Total Number of Hospital Visits	Total number of hospital visits during the study period	6 months
Total Number of Complications	Total number of complications including urinary tract infections, pneumonia, diabetic foot infection, cardiac complications including myocardial infarction and heart failure, cerebrovascular accidents, and acute kidney injury and mortality.	6 months
Incidence of Acute Kidney Injury	Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy	over 6 months
Mortality	Mortality is defined as death occurring during admission at the LTC facility	over 6 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: American Diabetes Association

Publications and helpful links

General Publications

• Umpierrez GE, Cardona S, Chachkhiani D, Fayfman M, Saiyed S, Wang H, Vellanki P, Haw JS, Olson DE, Pasquel FJ, Johnson TM 2nd. 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. J Am Med Dir Assoc. 2018 May;19(5):399-404.e3. doi: 10.1016/j.jamda.2017.11.002. Epub 2017 Dec 27. Erratum In: J Am Med Dir Assoc. 2019 Jul;20(7):925.

Study record dates

Study Major Dates

• Study Start: April 25, 2014
• Primary Completion (Actual): April 10, 2017
• Study Completion (Actual): April 10, 2017

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: older patients; type 2 diabetes; hyperglycemia; elderly patients; nursing home facility; long-term care facility
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Insulin Glargine; Linagliptin
• Other Study ID Numbers: IRB00071545; IRB00071946 (Other Identifier: VA site IRB number)