| Trial ID: | L5818 |
| Source ID: | NCT03013985
|
| Associated Drug: |
Glargine U300
|
| Title: |
Glargine U300 Hospital Trial
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03013985/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Glargine U300|DRUG: Glargine U100|DRUG: Glulisine Insulin
|
| Outcome Measures: |
Primary: Mean Daily Blood Glucose Concentration Inpatient, The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay., up to 10 days (day of hospital discharge)|Mean Daily Blood Glucose Concentration After Hospital Discharge, Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated., assessed from day 11 (day after hospital discharge) up to 3 months | Secondary: Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%, Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated., up to 3 months post enrollment|Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%, Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded, up to 3 months post enrollment|Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days, Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days, Up to 3 days|Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days, Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days, Up to 5 days|Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days, Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated., Up to 10 days|Percent of Blood Glucose 70-180 Measured by Point of Care Test, Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test, 3 months post enrollment|Percent of Subjects With Hypoglycemic Events, Percent of of subjects with hypoglycemic events (BG \< 70 mg/dl) will be recorded., 3 months post enrollment|Percent of Subjects With Severe Hypoglycemia, Percent of subjects experiencing severe hypoglycemia (BG \<54 mg/dl) will be recorded., 3 months post enrollment|Number of Days of Hospital Stay, The number of days of hospital stay for each subject will be recorded., Up to 10 days|Number Subjects With Cardiac Complications, The number of subjects experiencing cardiac cardiac complications will be recorded., 3 months post enrollment|Number of Patients With Acute Renal Failure, The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine \> 0.5 mg/dL from baseline)., 3 months post enrollment|Hospital Mortality, Number of hospital deaths that occur., During hospital stay - up to 10 days
|
| Sponsor/Collaborators: |
Sponsor: Emory University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
247
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2017-05-17
|
| Completion Date: |
2019-03-22
|
| Results First Posted: |
2020-05-07
|
| Last Update Posted: |
2020-05-07
|
| Locations: |
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Emory University, Atlanta, Georgia, 30322, United States|Hennepin County Medical Center, Minneapolis, Minnesota, 55415, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03013985
|
