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Clinical Trial Details

Trial ID: L3674
Source ID: NCT02061969
Associated Drug: Linagliptin
Title: ADA Linagliptin in Long Term Care
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02061969/results
Conditions: Diabetes
Interventions: DRUG: linagliptin|DRUG: insulin glargine
Outcome Measures: 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., 6 months | Secondary: HbA1c, HbA1c at 6 month, 6 months|Number of Hypoglycemic Events < 70mg/dl, total number of hypoglycemic events (\<70 mg/dl), over 6 months|Number of Hypoglycemic Events < 40mg/dl, total number of severe hypoglycemia (\< 40 mg/dl)., over 6 months|Total Daily Dose of Insulin, Total daily dose of insulin (units), over 6 months|Changes in Cognitive Function, Data on changes in cognitive function were not collected, over 6 months|Number of Participants With Acute Complications, Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection)., over 6 months|Total Number of Emergency Room Visits, Total number of emergency room visits during the study period, 6 months|Total Number of Hospital Visits, Total number of hospital visits during the study period, 6 months|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., 6 months|Incidence of Acute Kidney Injury, Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy, over 6 months|Mortality, Mortality is defined as death occurring during admission at the LTC facility, over 6 months
Sponsor/Collaborators: Sponsor: Emory University | Collaborators: American Diabetes Association
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 140
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-04-25
Completion Date: 2017-04-10
Results First Posted: 2018-08-22
Last Update Posted: 2018-08-22
Locations: Crestvew Nursing Home, Atlanta, Georgia, 30315, United States|Budd Terrace Nursing Home, Atlanta, Georgia, 30322, United States|Wesley Woods Nursing Home, Atlanta, Georgia, 30322, United States|VA Nursing Home, Decatur, Georgia, 30033, United States
URL: https://clinicaltrials.gov/show/NCT02061969