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Clinical Trial Details

Trial ID: L3957
Source ID: NCT03881995
Associated Drug: Iglarlixi
Title: Effects of Insulin Glargine and Lixisenatide on the Brain
Acronym: Lixibrain01
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: IGlarLixi|DRUG: Insulin Glargine 100 UNT/ML
Outcome Measures: Primary: Brain insulin sensitivity, Effect of 12 weeks treatment with iGlarLixi or Glargine on brain insulin sensitivity assessed by functional magnetic resonance imaging (fMRI) as change in regional cerebral blood flow (rCBF) from before to 30 minutes after nasal insulin spray application., Change from baseline brain insulin sensitivity at 12 weeks | Secondary: Processing of food pictures, Effect of 12 weeks treatment with iGlarLixi or Glargine on resting state brain activity and on brain response to food pictures and control pictures as assessed by functional magnetic resonance imaging., Change from baseline processing of food pictures at 12 weeks|Cognitive function, Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established Motor Screening Task (MOT). Outcome measures: assess the participant's speed of response and the accuracy of pointing. It is part of Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess neurocognition. All CANTAB tests are evaluated together., Change from baseline participant's speed of response and the accuracy of pointing at 12 weeks|Cognitive function, Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established Reaction Time (RTI). Outcome measures: Reaction time and movement time for both the simple and five-choice variants. It is part of Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess neurocognition. All CANTAB tests are evaluated together., Change from baseline reaction time and movement time at 12 weeks|Cognitive function, Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established Rapid Visual Information Processing (RVP). Outcome measures: Latency (speed of response), probability of false alarms and sensitivity. It is part of Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess neurocognition. All CANTAB tests are evaluated together., Change from baseline latency, probability of false alarms and sensitivity at 12 weeks|Cognitive function, Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established Paired Associates Learning (PAL). Outcome measures: Errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. It is part of Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess neurocognition. All CANTAB tests are evaluated together., Change from errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed baseline at 12 weeks|Cognitive function, Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established Spatial Working Memory (SWM). Outcome measures: errors (selecting boxes that have already been found to be empty and revisiting boxes which have already been found to contain a token) and strategy. It is part of Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess neurocognition. All CANTAB tests are evaluated together., Change from baseline errors and strategy at 12 weeks|Cognitive function, Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established Pattern Recognition Memory (PRM). Outcome measures: Number and percentage of correct trials and latency (speed of participant's response) It is part of Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess neurocognition. All CANTAB tests are evaluated together., Change from baseline number and percentage of correct trials and latency at 12 weeks|Cognitive function, Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established Delayed Matching to Sample (DMS). Outcome measures: Latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response. It is part of Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess neurocognition. All CANTAB tests are evaluated together., Change from baseline latency, the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response at 12 weeks|Glycemic control, Effect of 12 weeks treatment with iGlarLixi or Glargine on glycemic control (HbA1c change from baseline to week 12., Change from baseline glycemic control at 12 weeks|Liver fat content, Will be assessed by liver MR-spectroscopy change from baseline to 12 weeks.Unit: \[%\], Change from baseline body fat distribution at 12 weeks|Total adipose tissue (TAT), Will be assessed by whole body MRI as change from baseline to 12 weeks. Unit: \[l\], Change from baseline body fat distribution at 12 weeks|Visceral adipose tissue (VAT), Will be assessed by whole body MRI as change from baseline to 12 weeks. Unit: \[l\], Change from baseline body fat distribution at 12 weeks|Subcutaneous adipose tissue (SCAT), Will be assessed by whole body MRI as change from baseline to 12 weeks. Unit: \[l\], Change from baseline body fat distribution at 12 weeks|Body fat, Will be assessed by bioelectric impedance analysis (BIA) as change from baseline to 12 weeks. Unit: \[%\], Change from baseline body fat at 12 weeks|Lean body mass, Will be assessed by bioelectric impedance analysis (BIA) as change from baseline to 12 weeks. Unit: \[kg\], Change from baseline body fat at 12 weeks|Body weight, Will be assessed as change from baseline to 12 weeks. Unit \[kg\], Change from baseline body weight at 12 weeks | Other: Hypoglycemia, Number of hypoglycemic events be recorded., 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after randomisation|Hypoglycemia time of day, Time of day for each hypoglycemic event (see therefore outcome 18) be recorded., 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after randomisation
Sponsor/Collaborators: Sponsor: University Hospital Tuebingen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 1
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2019-03-18
Completion Date: 2020-06-29
Results First Posted:
Last Update Posted: 2020-07-10
Locations: University of Tuebingen, Department of Internal Medicine IV, Tübingen, 72076, Germany
URL: https://clinicaltrials.gov/show/NCT03881995