| Trial ID: | L3051 |
| Source ID: | NCT02830048
|
| Associated Drug: |
Glibenclamide
|
| Title: |
Low dosE GlibENclamide in Diabetes Part A
|
| Acronym: |
LEGEND-A
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Glibenclamide
|
| Outcome Measures: |
Primary: Decrease in fasting plasma glucagon concentration, Concentration of plasma glucagon using fasting blood samples prior to each dose change., After 3-4 days of treatment at each dose increment | Secondary: Overall improvement in glycaemic control throughout the day, Change in the percentage of Continuous Glucose Monitoring (CGM) readings under 4 mmol/L, between 4-10 mmol/L and above 10 mmol/L before starting glibenclamide and prior to each change in dose., After 3-4 days of treatment at each dose increment|Effect on fasting glucose, insulin and C-peptide levels, Concentration of glucose, insulin and C-peptide using fasting blood samples prior to each dose change., After 3-4 days of treatment at each dose increment|Pre-dose plasma concentration of glibenclamide, Concentration of plasma glibenclamide using fasting blood samples prior to each dose change., After 3-4 days of treatment at each dose increment
|
| Sponsor/Collaborators: |
Sponsor: University of Oxford | Collaborators: Oxford University Hospitals NHS Trust
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-07
|
| Completion Date: |
2017-03-09
|
| Results First Posted: |
|
| Last Update Posted: |
2017-05-31
|
| Locations: |
Clinical Research Unit, OCDEM, Churchill Hospital, Oxford, Oxfordshire, OX3 7LE, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02830048
|
