ADA Linagliptin in Long Term Care

Phase 4CompletedNCT02061969

Emory University140 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Diabetes

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Crestvew Nursing Home

Atlanta, Georgia, United States

Budd Terrace Nursing Home

Atlanta, Georgia, United States

Wesley Woods Nursing Home

Atlanta, Georgia, United States

VA Nursing Home

Decatur, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

HbA1c

HbA1c at 6 month

Time frame: 6 months

Number of Hypoglycemic Events < 70mg/dl

total number of hypoglycemic events (\<70 mg/dl)

Time frame: over 6 months

Number of Hypoglycemic Events < 40mg/dl

total number of severe hypoglycemia (\< 40 mg/dl).

Time frame: over 6 months

Total Daily Dose of Insulin

Total daily dose of insulin (units)

Time frame: over 6 months

Changes in Cognitive Function

Data on changes in cognitive function were not collected

Time frame: over 6 months

Number of Participants With Acute Complications

Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).

Time frame: over 6 months

Total Number of Emergency Room Visits

Total number of emergency room visits during the study period

Time frame: 6 months

Total Number of Hospital Visits

Total number of hospital visits during the study period

Time frame: 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.

Time frame: 6 months

Incidence of Acute Kidney Injury

Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy

Time frame: over 6 months

Mortality

Mortality is defined as death occurring during admission at the LTC facility

Time frame: over 6 months