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Clinical Trial Details

Trial ID: L2035
Source ID: NCT02455076
Associated Drug: Exenatide
Title: Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02455076/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Exenatide|DRUG: Glargine|DRUG: Rapid-acting insulin analogs
Outcome Measures: Primary: Mean Daily Blood Glucose Concentration Inpatient, The levels of blood glucose (BG) will be measured before each meal and at bedtime using a glucose meter. Blood glucose will be measured at baseline and during the hospital stay (up to 10 days)., Duration of hospital stay, an expected average of 10 days.|Change in HbA1c Concentration Inpatient, The difference in the levels of HbA1c at discharge and at 12 weeks from discharge will be measured. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent., 12 weeks from discharge. | Secondary: Mean Fasting Blood Glucose Levels Inpatient, The blood glucose levels prior to the patient's first meal of the day will be assessed using a glucose meter., Duration of hospital stay, an expected average of 10 days.|Mean Premeal Blood Glucose Levels Inpatient, The blood glucose levels prior to each meal will using a glucose meter., Duration of hospital stay, an expected average of 10 days|Incidence of Hypoglycemic Events Inpatient, The number of patients with hypoglycemia (blood glucose levels \< 70 mg/dL) will be recorded., Duration of hospital stay, an expected average of 10 days|Incidence of Hyperglycemic Events Inpatient, Percent of readings with hyperglycemia (blood glucose levels \> 240 mg/dL), Duration of hospital stay, an expected average of 10 days|Total Daily Dose of Insulin Inpatient, The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded., Duration of hospital stay, an expected average of 10 days|Average Number of Days of Hospital Stay, The average number of days in the hospital for subjects will be calculated., Duration of hospital stay, an expected average of 10 days|Incidence of the Need for ICU Care Inpatient, The total number of patients who require transfer to the ICU will be recorded., Duration of hospital stay, an expected average of 10 days|Hospital Mortality, The total number of subject deaths during hospital stay will be recorded., Duration of hospital stay, an expected average of 10 days|Hospital Complications, The total number of subjects who experience hospital complications like nosocomial pneumonia, bacteremia, respiratory failure, acute renal failure, and wound infections (surgery patients) will be recorded. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria., Duration of hospital stay, an expected average of 10 days|Incidence of Acute Kidney Injury Inpatient, The number of patients who experience acute kidney injury diagnosed by an increment in serum creatinine \>0.5 mg/dL from admission value or 50% of baseline value will be recorded., Duration of hospital stay, an expected average of 10 days|Incidence of Gastrointestinal Adverse Events Inpatient, The number of subjects who experience gastrointestinal side effects including nausea, vomiting and diarrhea will be recorded., Duration of hospital stay, an expected average of 10 days|Number of Patients With Severe Hypoglycemic Events Inpatient, Occurrences of hypoglycemia (blood glucose levels \< 40 mg/dL) will be recorded., Duration of hospital stay, an expected average of 10 days|Incidence of Hospital Readmissions, The number of patients who require readmission to the hospital from the time of discharge to 12 weeks after discharge will be recorded., 12 weeks after discharge|Mean Fasting Blood Glucose Levels During Outpatient Period, Fasting Blood Glucose Levels were measured using blood test, 12 weeks after discharge|Mean Daily Blood Glucose Concentration During Outpatient Period, Mean Daily Blood Glucose Concentration will be calculated and recorded., 12 weeks after discharge|The Number of Patients With Hypoglycemia Outpatient, Occurrence of hypoglycemia (blood glucose levels \< 70 mg) will be identified by blood test, 12 weeks after discharge|Number of Patients With Severe Hypoglycemic Events, Occurrences of hypoglycemia (blood glucose levels \< 40 mg/dL) will be detected by blood test, 12 weeks after discharge|Change in Body Weight, The change in Body Weight from discharge to 12 weeks after discharge will be recorded, Time of discharge, 12 weeks after discharge|Change in Body Mass Index, The change in BMI from discharge to 12 weeks after discharge will be calculated, Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge|Number of Patients Who Had Emergency Room Visits, The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded., 12 weeks after discharge|Number of Hospital Readmissions, Number of hospital readmissions during 12 weeks after discharge will be recorded, 12 weeks after discharge|Number of Acute Kidney Injury Events, Number of Acute Kidney Injury events will be recorded, 12 weeks from discharge.|Number of Severe Gastrointestinal Adverse Events, Number of Severe (require hospitalization) Gastrointestinal Adverse Events, 12 weeks from discharge.|Change in Systolic Blood Pressure, Change in Systolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded, Discharge (after day 10 or hospital stay), 12 weeks after discharge|Change in Heart Rate, Change in heart rate from the time of discharge to 12 weeks after discharge will be recorded, Discharge (after day 10 or hospital stay), 12 weeks after discharge|Efficacy, Measured by HbA1c Levels and no Weight Gain, Number of patients who have an HbA1c \<7.0% and no weight gain at 12 weeks from discharge will be recorded., 12 weeks from discharge.|Efficacy, Measured by HbA1c Levels and no Hypoglycemia, Number of patients who have an HbA1c \<7.0% and no hypoglycemia at 12 weeks from discharge will be recorded., 12 weeks from discharge.|Change in Diastolic Blood Pressure, Change in Diastolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded, Discharge (after day 10 or hospital stay), 12 weeks after discharge
Sponsor/Collaborators: Sponsor: Emory University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-09
Completion Date: 2018-03
Results First Posted: 2019-06-20
Last Update Posted: 2019-06-20
Locations: Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Emory University Hospital, Atlanta, Georgia, 30322, United States
URL: https://clinicaltrials.gov/show/NCT02455076