Trial Outcomes & Findings for ADA Linagliptin in Long Term Care (NCT NCT02061969)
NCT ID: NCT02061969
Last Updated: 2018-08-22
Results Overview
The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
6 months
Results posted on
2018-08-22
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
67
|
|
Overall Study
COMPLETED
|
73
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ADA Linagliptin in Long Term Care
Baseline characteristics by cohort
| Measure |
Insulin Glargine
n=73 Participants
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.
|
Linagliptin
n=67 Participants
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.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 13 • n=99 Participants
|
68 years
STANDARD_DEVIATION 14 • n=107 Participants
|
69.8 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=99 Participants
|
67 participants
n=107 Participants
|
140 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Mean Fasting Blood Glucose Level
|
136.4 mg/dl
Standard Deviation 35
|
131.2 mg/dl
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 6 monthsHbA1c at 6 month
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
HbA1c
|
6.58 percent of glycosylated hemoglobin
Standard Deviation 0.7
|
6.82 percent of glycosylated hemoglobin
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: over 6 monthstotal number of hypoglycemic events (\<70 mg/dl)
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Number of Hypoglycemic Events < 70mg/dl
|
136 events
|
3 events
|
SECONDARY outcome
Timeframe: over 6 monthstotal number of severe hypoglycemia (\< 40 mg/dl).
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Number of Hypoglycemic Events < 40mg/dl
|
3 events
|
0 events
|
SECONDARY outcome
Timeframe: over 6 monthsTotal daily dose of insulin (units)
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Total Daily Dose of Insulin
|
12.0 U/day
Standard Deviation 9.9
|
4.03 U/day
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: over 6 monthsPopulation: Data were not collected
Data on changes in cognitive function were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: over 6 monthsNumber of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Number of Participants With Acute Complications
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsTotal number of emergency room visits during the study period
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Total Number of Emergency Room Visits
|
3 visits
|
0 visits
|
SECONDARY outcome
Timeframe: 6 monthsTotal number of hospital visits during the study period
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Total Number of Hospital Visits
|
6 visits
|
7 visits
|
SECONDARY outcome
Timeframe: 6 monthsTotal 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.
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Total Number of Complications
|
22 events
|
16 events
|
SECONDARY outcome
Timeframe: over 6 monthsAcute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Incidence of Acute Kidney Injury
|
2 events
|
1 events
|
SECONDARY outcome
Timeframe: over 6 monthsMortality is defined as death occurring during admission at the LTC facility
Outcome measures
| Measure |
Insulin Glargine
n=73 Participants
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
|
Linagliptin
n=67 Participants
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
|
|---|---|---|
|
Mortality
|
0 Participants
|
2 Participants
|
Adverse Events
Insulin Glargine
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Linagliptin
Serious events: 4 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Insulin Glargine
n=73 participants at risk
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
|
Linagliptin
n=67 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
Hospitalized for Altered Mental Status
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Hospitalized for repair craninectomy
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for aspiration pneumonia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pleural effusion
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Cardiac disorders
Hospitalization for congestive heart failure ( exacerbation
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Infections and infestations
Right stump infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Nervous system disorders
Hospitalized for brain edema
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Cardiac disorders
Hospitalized for severe aortic stenosis
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Amputation of the left 2nd toe
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Insulin Glargine
n=73 participants at risk
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
|
Linagliptin
n=67 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Shingels
|
0.00%
0/73 • 6 months
|
3.0%
2/67 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
8.2%
6/73 • Number of events 6 • 6 months
|
4.5%
3/67 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.7%
2/73 • Number of events 2 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/73 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute renal failure
|
4.1%
3/73 • Number of events 3 • 6 months
|
0.00%
0/67 • 6 months
|
|
Cardiac disorders
Bradicardia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Cardiac disorders
Hypotension
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Reproductive system and breast disorders
Penile infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fall
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place