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Clinical Trial Details

Trial ID: L4361
Source ID: NCT03244241
Associated Drug: Insulin Degludec 100 Unt/Ml [Tresiba]
Title: Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin Degludec 100 UNT/ML [Tresiba]
Outcome Measures: Primary: Difference in mean daily plasma glucose between the two groups, Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient., Duration of hospital stay, an expected average of 8 days | Secondary: Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L), Based on bedside PG measures and on CGM data, Duration of hospital stay, an expected average of 8 days|Time spent in glycemic range, Based on bedside PG measures and on CGM data, Duration of hospital stay, an expected average of 8 days|Time spent in hyperglycemic range, Based on bedside PG measures and on CGM data, Duration of hospital stay, an expected average of 8 days|Length of hospital stay, Mean duration of hospital stay, Duration of hospital stay, an expected average of 8 days|Difference in insulin dose between groups, Calculated as mean insulin dose during admission, Duration of hospital stay, an expected average of 8 days|Number of hospital acquired infections during admission, Data from hospital record, Duration of hospital stay, an expected average of 8 days|Number of post-discharge infections or re-admissions 1 month after discharge, Data collected on follow-up 1 month after discharge, 1 month
Sponsor/Collaborators: Sponsor: Merete Bechmann Christensen | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-04-01
Completion Date: 2018-04-01
Results First Posted:
Last Update Posted: 2017-08-09
Locations: Hvidovre University Hospital, Hvidovre, 2650, Denmark
URL: https://clinicaltrials.gov/show/NCT03244241