ADA Linagliptin in Long Term Care

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061969
• Other study ID #: IRB00071545
• Secondary ID: IRB00071946
• Status: Completed
• Phase: Phase 4
• Start date: April 25, 2014
• Est. completion date: April 10, 2017

Study information

• Verified date: July 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 10, 2017
• Est. primary completion date: April 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• linagliptin
5mg linagliptin tablets
• insulin glargine

Locations

Country	Name	City	State
United States	Budd Terrace Nursing Home	Atlanta	Georgia
United States	Crestvew Nursing Home	Atlanta	Georgia
United States	Wesley Woods Nursing Home	Atlanta	Georgia
United States	VA Nursing Home	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

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