Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2911
Source ID: NCT01919489
Associated Drug: Liraglutide + Oads
Title: Liraglutide Hospital Discharge Trial
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01919489/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Liraglutide + OADs|DRUG: Glargine + OADs
Outcome Measures: Primary: Glycemic Control at Hospital Discharge and 6 Months Follow up, To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy, Hospital discharge, 6 months (26 weeks) | Secondary: Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks, To determine differences in BG concentration between liraglutide and glargine insulin therapy, After discharge, average at 3 months (12 week) and 6 months (26 weeks)|Hypoglycemic Episodes, Number of participants who had at least one hypoglycemic event (\<70 mg/dl) and severe hypoglycemic event (\<40 mg/dl), After discharge, average 6 months|HbA1c <7.0% and no Hypoglycemia, Percent of patients with 26 week HbA1c \<7.0% and no hypoglycemia, After discharge, average 6 months|HbA1c <7.0% and no Weight Gain, Percent of patients with 26 week HbA1c \<7.0% and no weight gain, After discharge, average 6 months|HbA1c <7.0% and no Hypoglycemia, Percent of patients with 12 week HbA1c \<7.0% and no hypoglycemia, After discharge, average 12 weeks|Change in Body Weight From Baseline, Change in body weight from baseline after 6 months of follow up (26 weeks), After discharge, average 6 months|Change in BMI, Change in BMI after 6 months from baseline, Baseline, and follow up after discharge (average 6 months)|Total Daily Dose of Insulin, Evaluate the total daily dose of insulin needed in the group receiving glargine, After discharge, average 6 months|Change in Cardiovascular Risk Factors: Blood Pressure, Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention, Baseline, 26 weeks post-intervention|Cardiovascular Risk Factor: Heart Rate, Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention, 26 weeks post-intervention|Cardiovascular Risk Factor: Lipid Profile, Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care., 26 weeks post-intervention|Emergency Room Visits and Readmissions, Number of participants who had at least one emergency room visit and hospital readmissions, After discharge, average 6 months|Acute Renal Failure, Acute renal failure during the 26-week follow-up defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment in creatinine \> 0.5 mg/dL from baseline), After discharge, average 6 months|Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up, Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up, 26 weeks post-intervention
Sponsor/Collaborators: Sponsor: Emory University | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 273
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-03
Completion Date: 2020-08-30
Results First Posted: 2021-11-03
Last Update Posted: 2021-11-03
Locations: University of Miami, Miami, Florida, United States|Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Emory University Hospital, Atlanta, Georgia, 30324, United States|Emory Universtiy Hospital at MIdtown, Atlanta, Georgia, United States|State University of NY at Buffalo, New York, New York, United States
URL: https://clinicaltrials.gov/show/NCT01919489