Clinical Trial Details
| Trial ID: | L7176 |
| Source ID: | NCT02308254 |
| Associated Drug: | Lixisenatide |
| Title: | Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People |
| Acronym: | Lixi |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus|Gastroparesis |
| Interventions: | DRUG: Lixisenatide|DRUG: Placebo |
| Outcome Measures: | Primary: Blood Pressure, Systolic and diastolic blood pressure (mmHg), 4.5 hours per study | Secondary: Heart rate, Heart rate (beats per minute), 4.5 hours per study|Gastric emptying rate, Gastric retention (percent in the total stomach), 3 hours per study|Blood glucose concentration, Blood glucose (mmol/L), 3 hours per study | Other: Intragastric distribution, percent retention in the proximal and distal stomach, 3 hours per study|Gastrointestinal hormone release (concentrations of GLP-1, GIP, C-peptide and 3-OMG), concentrations of GLP-1, GIP, C-peptide and 3-OMG, 4.5 hours per study|Superior mesenteric artery blood flow, Doppler ultrasound (ml/min), 3.5 hours per study|Appetite (visual analogue questionnaire), sensations of hunger, fullness, desire to eat (mm), 4.5 hours per study|Cardiac output, Finapres (L), 3.5 hours per study|Stroke volume, Finapres (L), 3.5 hours per study |
| Sponsor/Collaborators: | Sponsor: Royal Adelaide Hospital | Collaborators: Sanofi|National Health and Medical Research Council, Australia |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1|PHASE2 |
| Enrollment: | 30 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-11 |
| Completion Date: | 2016-04 |
| Results First Posted: | |
| Last Update Posted: | 2015-10-29 |
| Locations: | Discipline of Medicine, Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia |
| URL: | https://clinicaltrials.gov/show/NCT02308254 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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