ADA Linagliptin in Long Term Care
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/24/2018 |
| Start Date: | April 25, 2014 |
| End Date: | April 10, 2017 |
A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes
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.
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.
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.
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