Trial · NCT04198948
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
NCT04198948, Phase 1, Completed, University of Sarajevo; results first posted 2021-07-15
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers. Trials, record NCT04198948. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04198948
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
- NCT number
- NCT04198948
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- University of Sarajevo
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Omeprazole, Placebo oral tablet, Gliclazide
- First posted
- 2019-12-13
- Last updated
- 2021-08-18
- Results first posted
- 2021-07-15
- Limitations and caveats
Participants received half of the 80 mg gliclazide tablet registered as an immediate-release formulation in Bosnia and Herzegovina (Diprian®, Hemofarm d.o.o. Banja Luka, B\&H). However, the concentration-time profiles showed modified-release pattern and incomplete elimination within 24h; thus Cmax, tmax, t1/2, and AUC0-∞ could not be determined. The obtained PK profiles were used at the end for validation of physiologically based pharmacokinetic simulation of omeprazole-gliclazide interaction.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gliclazide AUC | 24 hours | Area under the concentration-time curve (AUC) up to the last concentration measured |
| Secondary | Glucose | 12 hours | Change in glucose concentration - incremental area under the glucose concentration-time curve from 0 to 12 h |
| Secondary | Insulin | 12 hours | Change in insulin concentration - incremental area under the insulin concentration-time curve from 0 to 12 h |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gliclazide AUC | 24 hours | A total of 14 participants who completed both study periods were included in the analysis. | μgh/mL | GEOMETRIC_MEAN |
| SECONDARY | Glucose | 12 hours | A total of 14 participants who completed both study periods were included in the analysis. | mmol x h/L | MEAN |
| SECONDARY | Insulin | 12 hours | A total of 14 participants who completed both study periods were included in the analysis. | mIU x h/L | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gliclazide AUC | Gliclazide + Omeprazole | 3.73 | 95% Confidence Interval 2.81 to 4.93 | μgh/mL | |
| Gliclazide AUC | Gliclazide + Placebo | 3.29 | 95% Confidence Interval 2.65 to 4.09 | μgh/mL | |
| Glucose | Gliclazide + Omeprazole | 4.6 | Standard Deviation 4.3 | mmol x h/L | |
| Glucose | Gliclazide + Placebo | 4.0 | Standard Deviation 3.0 | mmol x h/L | |
| Insulin | Gliclazide + Omeprazole | 231.6 | Standard Deviation 93.8 | mIU x h/L | |
| Insulin | Gliclazide + Placebo | 265.9 | Standard Deviation 78.2 | mIU x h/L |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Period | STARTED | Omeprazole, Then Placebo | 7 | |
| First Period | STARTED | Placebo, Then Omeprazole | 8 | |
| First Period | COMPLETED | Omeprazole, Then Placebo | 7 | |
| First Period | COMPLETED | Placebo, Then Omeprazole | 8 | |
| First Period | NOT COMPLETED | Omeprazole, Then Placebo | 0 | |
| First Period | NOT COMPLETED | Placebo, Then Omeprazole | 0 | |
| Wash-out (10 Days) | STARTED | Omeprazole, Then Placebo | 7 | |
| Wash-out (10 Days) | STARTED | Placebo, Then Omeprazole | 8 | |
| Wash-out (10 Days) | COMPLETED | Omeprazole, Then Placebo | 7 | |
| Wash-out (10 Days) | COMPLETED | Placebo, Then Omeprazole | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gliclazide + Omeprazole | 0 | 15 |
| Total, all-cause mortality | Gliclazide + Placebo | 0 | 15 |
| Total, other adverse events | Gliclazide + Omeprazole | 0 | 15 |
| Total, other adverse events | Gliclazide + Placebo | 0 | 15 |
| Total, serious adverse events | Gliclazide + Omeprazole | 0 | 15 |
| Total, serious adverse events | Gliclazide + Placebo | 0 | 15 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gliclazide + Omeprazole vs Gliclazide + Placebo: deaths from any cause | Trial comparisons |
| Gliclazide + Omeprazole vs Gliclazide + Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04198948
GET https://conductscience.org/api/trials/v1/NCT04198948/registered