A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 140
- Locations
- 4
- Primary Endpoint
- Mean Fasting Blood Glucose Level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: insulin glargine (Drug)
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.
Intervention: linagliptin (Drug)
Outcomes
Primary Outcomes
Mean Fasting Blood Glucose Level
Time Frame: 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 Outcomes
- Number of Hypoglycemic Events < 40mg/dl(over 6 months)
- Total Daily Dose of Insulin(over 6 months)
- HbA1c(6 months)
- Number of Hypoglycemic Events < 70mg/dl(over 6 months)
- Changes in Cognitive Function(over 6 months)
- Number of Participants With Acute Complications(over 6 months)
- Total Number of Emergency Room Visits(6 months)
- Total Number of Hospital Visits(6 months)
- Total Number of Complications(6 months)
- Incidence of Acute Kidney Injury(over 6 months)
- Mortality(over 6 months)
Investigators
Guillermo Umpierrez, MD
Professor of Medicine
Emory University