Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers (INTERGLIKOM)

July 19, 2021 updated by: Tanja Dujic, PhD, University of Sarajevo

Proton pump inhibitors (PPIs) are treatment of choice for different gastrointestinal disorders common in type 2 diabetes. Sulfonylureas (SUs) are anti-diabetes agents particularly widely used in developing countries. Gliclazide, a recommended SU drug, is metabolised in part by CYP2C19, the main enzyme responsible for the PPI metabolism.

A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12 hours after gliclazide administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men
  • Age 18-30 years
  • Non-smokers
  • CYP2C19 extensive/ultrarapid metabolisers

Exclusion Criteria:

  • medical history of hepatic, renal, gastrointestinal and hematologic disease or any acute or chronic disease, or drug allergy to sulfonylureas or PPIs or history of drug abuse
  • abnormalities in physical examination, ECG and routine clinical laboratory tests (including fasting blood glucose concentration)
  • medication use during the 14 days prior and during the study period
  • grapefruit, grapefruit juice, alcohol, beverages or food containing methylxanthines use during 72 h prior and during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omeprazole, Then Placebo
Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive 20 mg of omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive placebo under same conditions in a cross-over manner.
Drug: Omeprazole
Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Drug: Placebo oral tablet
Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Drug: Gliclazide
Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
Experimental: Placebo, Then Omeprazole
Healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers, will receive placebo alone for 4 days, and concomitantly with single dose of gliclazide on day 5. After a wash-out period, they will receive omeprazole under same conditions in a cross-over manner.
Drug: Omeprazole
Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
Drug: Placebo oral tablet
Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
Drug: Gliclazide
Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gliclazide AUC
Time Frame: 24 hours
Area under the concentration-time curve (AUC) up to the last concentration measured
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: 12 hours
Change in glucose concentration - incremental area under the glucose concentration-time curve from 0 to 12 h
12 hours
Insulin
Time Frame: 12 hours
Change in insulin concentration - incremental area under the insulin concentration-time curve from 0 to 12 h
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sarajevo

Collaborators

Wellcome Trust
University of Dundee
General Hospital Prim. Dr. Abdulah Nakas

Investigators

  • Principal Investigator: Tanja Dujic, PhD, University of Sarajevo
  • Principal Investigator: Aida Kulo Cesic, PhD, University of Sarajevo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

August 5, 2019

Study Completion (Actual)

August 5, 2019

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0101-3678/18
  • 209943/Z/17/Z (Other Grant/Funding Number: Wellcome Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data may be shared with researchers who provide a methodologically sound proposal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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