Phase 4
N=140
ADA Linagliptin in Long Term Care
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02061969 ↗Enrolled (actual)
140
Serious AEs
7.1%
Results posted
Aug 2018
Primary outcome: Primary: Mean Fasting Blood Glucose Level — 136.4; 131.2 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- linagliptin (Drug); insulin glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Fasting Blood Glucose Level |
136.4; 131.2 | — |
| SECONDARY HbA1c |
6.58; 6.82 | — |
| SECONDARY Number of Hypoglycemic Events < 70mg/dl |
136; 3 | — |
| SECONDARY Number of Hypoglycemic Events < 40mg/dl |
3; 0 | — |
| SECONDARY Total Daily Dose of Insulin |
12.0; 4.03 | — |
| SECONDARY Changes in Cognitive Function |
— | — |
| SECONDARY Number of Participants With Acute Complications |
8; 5 | — |
| SECONDARY Total Number of Emergency Room Visits |
3; 0 | — |
| SECONDARY Total Number of Hospital Visits |
6; 7 | — |
| SECONDARY Total Number of Complications |
22; 16 | — |
| SECONDARY Incidence of Acute Kidney Injury |
2; 1 | — |
| SECONDARY Mortality |
0; 2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02061969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.