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Clinical Trial Details

Trial ID: L1919
Source ID: NCT02408120
Associated Drug: Insulin Glargine
Title: Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02408120/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin glargine|DRUG: Insulin aspart|DRUG: Supplemental insulin aspart
Outcome Measures: Primary: Mean Daily BG Levels, Blood glucose (BG) will be measured, and mean daily BG levels will be calculated., 5 days (average time of discharge from the hospital) | Secondary: Mean Blood Glucose Levels Before Lunch, The blood glucose levels will be assessed prior to lunch using a glucose meter., 5 days (average time of discharge from the hospital)|Mean Blood Glucose Levels at Bedtime, The blood glucose levels will be assessed at bedtime using a glucose meter., 5 days (average time of discharge from the hospital)|Mean Blood Glucose Levels Before Dinner, The blood glucose levels will be assessed before dinner using a glucose meter., 5 days (average time of discharge from the hospital)|Number of Hypoglycemia Events, The number of occurrences of hypoglycemia (blood glucose levels \< 70 mg/dL) will be recorded., 5 days (average time of discharge from the hospital)|Incidence of Hyperglycemia, The number of occurrences of hyperglycemia (blood glucose levels \> 260 mg/dL) will be recorded., 5 days (average time of discharge from the hospital)|Number of Blood Glucose Readings Within 100-140 mg/dL Range, The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded., 5 days (average time of discharge from the hospital)|Average Number of Days of Hospital Stay, The average number of days in the hospital for subjects will be calculated., 5 days (average time of discharge from the hospital)|Mortality, The total number of subject deaths during hospital stay will be recorded., 5 days (average time of discharge from the hospital)|Number of Subjects That Experienced Hospital Complications, The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury \[rise of serum creatinine \>0.5 mg/dL (or 50%) of baseline value\]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria., 5 days (average time of discharge from the hospital)|Mean Daily Dose of Insulin, Daily dose of insulin will be recorded, 5 days (average time of discharge from the hospital)
Sponsor/Collaborators: Sponsor: Emory University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 226
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2015-10
Completion Date: 2019-12-11
Results First Posted: 2021-01-06
Last Update Posted: 2023-09-28
Locations: Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Emory University Hospital, Atlanta, Georgia, 30322, United States
URL: https://clinicaltrials.gov/show/NCT02408120