| Trial ID: | L1829 |
| Source ID: | NCT04198948
|
| Associated Drug: |
Omeprazole
|
| Title: |
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
|
| Acronym: |
INTERGLIKOM
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04198948/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Omeprazole|DRUG: Placebo oral tablet|DRUG: Gliclazide
|
| Outcome Measures: |
Primary: Gliclazide AUC, Area under the concentration-time curve (AUC) up to the last concentration measured, 24 hours | Secondary: Glucose, Change in glucose concentration - incremental area under the glucose concentration-time curve from 0 to 12 h, 12 hours|Insulin, Change in insulin concentration - incremental area under the insulin concentration-time curve from 0 to 12 h, 12 hours
|
| Sponsor/Collaborators: |
Sponsor: University of Sarajevo | Collaborators: General Hospital Prim. Dr. Abdulah Nakas|University of Dundee|Wellcome Trust
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2019-03-04
|
| Completion Date: |
2019-08-05
|
| Results First Posted: |
2021-07-15
|
| Last Update Posted: |
2021-08-18
|
| Locations: |
General Hospital Prim. Dr. Abdulah Nakas, Sarajevo, 71000, Bosnia and Herzegovina
|
| URL: |
https://clinicaltrials.gov/show/NCT04198948
|
