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Clinical Trial Details

Trial ID: L3189
Source ID: NCT02004366
Associated Drug: Linagliptin
Title: Linagliptin Inpatient Trial
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02004366/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Linagliptin|DRUG: Basal Bolus|DRUG: Linagliptin|DRUG: Linagliptin + 50% Glargine dose on discharge|DRUG: Linagliptin + 80% Glargine
Outcome Measures: Primary: Differences in Glycemic Control, Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group., Inpatient (average 5 days) and outpatient up to 12 weeks | Secondary: Hypoglycemia <70 mg/dl, Subjects with Hypoglycemia \<70 mg/dl, Inpatient (average 5 days) and outpatient up to 12 weeks|Hyperglycemia, Subjects with BG \> 300 mg/dl, Inpatient (average 5 days) and outpatient up to 12 weeks|Daily Dose of Insulin, Total daily dose of insulin, Inpatient (average 5 days) and outpatient up to 12 weeks|Length of Hospital Stay, Length of hospital stay (ONLY for inpatient arms 1 and 2), During Hospitalization|Number of Participants Requiring ICU Care During Hospitalization, Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization, During Hospitalization-average 5 days|Hospital Complications, Subjects with composite complication (ONLY for inpatient arms 1 and 2), During Hospitalization-average 5 days|Acute Renal Failure During Hospitalization, Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2), During Hospitalization-average 5 days|Hospital Mortality, Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay., During Hospitalization-average 5 days|Fasting BG Concentration, Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups), During Hospitalization (average 5 days) and outpatient up to 12 weeks|Subjects With Wound and Other Infections, Subjects with wound and other infections., During Hospitalization and outpatient up to 12 weeks|HbA1c Level, HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms)., Admission to the hospital and 12-week follow-up outpatient visit|Hypoglycemia < 40 mg/dl, Subjects with Hypoglycemia \< 40 mg/dl, Inpatient and up to 12 weeks outpatient|Emergency Room Visits, Number of ER visits ONLY for outpatient arms 3,4, and 5., 3 months after discharge|Subjects With Surgical Reinterventions, Subjects with surgical re-interventions., Inpatient and up to 12 weeks outpatient|Outpatient Mortality, Deaths among patients after hospital discharge., 3 months after discharge
Sponsor/Collaborators: Sponsor: Emory University | Collaborators: Boston Medical Center|Rush University|University of Denver
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 295
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-01
Completion Date: 2017-03
Results First Posted: 2018-10-30
Last Update Posted: 2019-02-20
Locations: University of Colorado, Denver, Colorado, 80220, United States|Emory University Hospital, Atlanta, Georgia, 30322, United States|Grady Memorial Hospital, Atlanta, Georgia, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|Boston Medical Center, Boston, Massachusetts, 02118, United States
URL: https://clinicaltrials.gov/show/NCT02004366