ADA Linagliptin in Long Term Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Drug: linagliptin
* Drug: insulin glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL Exclusion Criteria: Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis Treatment with insulin or GLP1 analogs during the past 3 months prior to admission. Recurrent severe hypoglycemia or hypoglycemic unawareness. Subjects with history of gastrointestinal obstruction or gastroparesis. Patients with acute or chronic pancreatitis or pancreatic cancer. 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). Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment. Mental condition rendering the subject unable to understand the nature and scope of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin glargine<br>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<br> <br> * Other names: Lantus;|
| Experimental: linagliptin<br>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<br>* 5mg linagliptin tablets<br>* Other names: Tradjenta;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nursing home facility, long-term care facility, older patients, elderly patients, hyperglycemia, type 2 diabetes