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Clinical Trial Details

Trial ID: L4074
Source ID: NCT02092896
Associated Drug: Liraglutide
Title: Liraglutide as add-on to Insulin in Type 1 Diabetes
Acronym: T1DMLIRA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: Liraglutide|DRUG: Placebo|DRUG: Liraglutide|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in HbA1c (glycosylated haemoglobin), Week 0, week 12|Changes from baseline in EEG and cognitive performances, week 0, week 12|Change from baseline in gastric emptying rate, week 0, week 12 | Secondary: Change from baseline in glycemic control (CGM), week 0, week 12|Change from baseline in total daily insulin dose, week 0, week 12|Changes from baseline in the counterregulatory hormone responses during hypoglycemia, week 0, week 12|Change from baseline in body weight, week 0, week 12|Change from baseline in auditory evoked potentials (AEP) during hypoglycemia, week 0, week 12|Change from baseline in corrected QTc-interval (QTc) during hypoglycemia, week 0, week 12|Change from baseline in hypoglycemic symptom score, week 0, week 12 | Other: Frequency of Hypoglycemic episodes, Week 0, week 12
Sponsor/Collaborators: Sponsor: Hvidovre University Hospital | Collaborators: NNF Center for Basal Metabolic Research, Denmark|Hillerod Hospital, Denmark|Danish PhD schools of Molecular Metabolism and Endocrinology|Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-03
Completion Date: 2014-10
Results First Posted:
Last Update Posted: 2015-04-01
Locations: Dept. of Endocrinology, Hvidovre University Hospital, Hvidovre, Copenhagen, 2650, Denmark
URL: https://clinicaltrials.gov/show/NCT02092896

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress