ADA Linagliptin in Long Term Care

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: insulin glargine; Drug: linagliptin

• Registration Number: NCT02061969
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Study Start: 2014-04-25
• Primary Completion: 2017-04-10
• Study Completion: 2017-04-10
• Results First Submitted: 2018-05-08
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-25
• Last Update Submitted: 2018-07-25
• Results First Posted: 2018-08-22
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin glargine	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.
linagliptin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Wesley Woods Nursing Home; 🇺🇸 Atlanta, Georgia, United States

VA Nursing Home; 🇺🇸 Decatur, Georgia, United States

Budd Terrace Nursing Home; 🇺🇸 Atlanta, Georgia, United States

Crestvew Nursing Home; 🇺🇸 Atlanta, Georgia, United States