Diabetes
Conditions
Keywords
nursing home facility, long-term care facility, older patients, elderly patients, hyperglycemia, type 2 diabetes
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.
Interventions
DRUGlinagliptin
5mg linagliptin tablets
DRUGinsulin glargine
Sponsors
American Diabetes Association
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Fasting Blood Glucose Level | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypoglycemic Events < 70mg/dl | over 6 months | total number of hypoglycemic events (\<70 mg/dl) |
| Number of Hypoglycemic Events < 40mg/dl | over 6 months | total number of severe hypoglycemia (\< 40 mg/dl). |
| Total Daily Dose of Insulin | over 6 months | Total daily dose of insulin (units) |
| Changes in Cognitive Function | over 6 months | Data on changes in cognitive function were not collected |
| Number of Participants With Acute Complications | over 6 months | Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection). |
| HbA1c | 6 months | HbA1c at 6 month |
| Total Number of Hospital Visits | 6 months | Total number of hospital visits during the study period |
| Total Number of Complications | 6 months | 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. |
| Incidence of Acute Kidney Injury | over 6 months | Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy |
| Mortality | over 6 months | Mortality is defined as death occurring during admission at the LTC facility |
| Total Number of Emergency Room Visits | 6 months | Total number of emergency room visits during the study period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Insulin glargine. | 73 |
| 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.
linagliptin: 5mg linagliptin tablets. | 67 |
| Total | 140 |
Baseline characteristics
| Characteristic | Insulin Glargine | Total | Linagliptin |
|---|---|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 13 | 69.8 years STANDARD_DEVIATION 13 | 68 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 84 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 52 Participants | 22 Participants |
| Region of Enrollment United States | 73 participants | 140 participants | 67 participants |
| Sex: Female, Male Female | 48 Participants | 83 Participants | 35 Participants |
| Sex: Female, Male Male | 25 Participants | 57 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 2 / 67 |
| other Total, other adverse events | 16 / 73 | 12 / 67 |
| serious Total, serious adverse events | 6 / 73 | 4 / 67 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | Mean Fasting Blood Glucose Level | 136.4 mg/dl | Standard Deviation 35 |
| Linagliptin | Mean Fasting Blood Glucose Level | 131.2 mg/dl | Standard Deviation 27 |
Secondary
Changes in Cognitive Function
Data on changes in cognitive function were not collected
Time frame: over 6 months
Population: Data were not collected
Secondary
HbA1c
HbA1c at 6 month
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | HbA1c | 6.58 percent of glycosylated hemoglobin | Standard Deviation 0.7 |
| Linagliptin | HbA1c | 6.82 percent of glycosylated hemoglobin | Standard Deviation 0.6 |
Secondary
Incidence of Acute Kidney Injury
Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy
Time frame: over 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | Incidence of Acute Kidney Injury | 2 events |
| Linagliptin | Incidence of Acute Kidney Injury | 1 events |
Secondary
Mortality
Mortality is defined as death occurring during admission at the LTC facility
Time frame: over 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insulin Glargine | Mortality | 0 Participants |
| Linagliptin | Mortality | 2 Participants |
Secondary
Number of Hypoglycemic Events < 40mg/dl
total number of severe hypoglycemia (\< 40 mg/dl).
Time frame: over 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | Number of Hypoglycemic Events < 40mg/dl | 3 events |
| Linagliptin | Number of Hypoglycemic Events < 40mg/dl | 0 events |
Secondary
Number of Hypoglycemic Events < 70mg/dl
total number of hypoglycemic events (\<70 mg/dl)
Time frame: over 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | Number of Hypoglycemic Events < 70mg/dl | 136 events |
| Linagliptin | Number of Hypoglycemic Events < 70mg/dl | 3 events |
Secondary
Number of Participants With Acute Complications
Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).
Time frame: over 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insulin Glargine | Number of Participants With Acute Complications | 8 Participants |
| Linagliptin | Number of Participants With Acute Complications | 5 Participants |
Secondary
Total Daily Dose of Insulin
Total daily dose of insulin (units)
Time frame: over 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | Total Daily Dose of Insulin | 12.0 U/day | Standard Deviation 9.9 |
| Linagliptin | Total Daily Dose of Insulin | 4.03 U/day | Standard Deviation 1.7 |
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | Total Number of Complications | 22 events |
| Linagliptin | Total Number of Complications | 16 events |
Secondary
Total Number of Emergency Room Visits
Total number of emergency room visits during the study period
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | Total Number of Emergency Room Visits | 3 visits |
| Linagliptin | Total Number of Emergency Room Visits | 0 visits |
Secondary
Total Number of Hospital Visits
Total number of hospital visits during the study period
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | Total Number of Hospital Visits | 6 visits |
| Linagliptin | Total Number of Hospital Visits | 7 visits |