Clinical trial NCT02061969: ADA Linagliptin in Long Term Care
Official title: A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: nursing home facility
long-term care facility
older patients
elderly patients
hyperglycemia
type 2 diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2014-02-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Fasting Blood Glucose Level
timeFrame: 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: 6 months
measure: Number of Hypoglycemic Events < 70mg/dl
timeFrame: over 6 months
measure: Number of Hypoglycemic Events < 40mg/dl
timeFrame: over 6 months
measure: Total Daily Dose of Insulin
timeFrame: over 6 months
measure: Changes in Cognitive Function
timeFrame: over 6 months
measure: Number of Participants With Acute Complications
timeFrame: over 6 months
measure: Total Number of Emergency Room Visits
timeFrame: 6 months
measure: Total Number of Hospital Visits
timeFrame: 6 months
measure: Total Number of Complications
timeFrame: 6 months
measure: Incidence of Acute Kidney Injury
timeFrame: over 6 months
measure: Mortality
timeFrame: over 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Crestvew Nursing Home
state: Georgia
city: Atlanta
country: United States
facility: Budd Terrace Nursing Home
state: Georgia
city: Atlanta
country: United States
facility: Wesley Woods Nursing Home
state: Georgia
city: Decatur
country: United States
facility: VA Nursing Home
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.