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

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ClinicalTrials.gov Identifier: NCT04198948
Recruitment Status : Completed
First Posted : December 13, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
General Hospital Prim. Dr. Abdulah Nakas
University of Dundee
Information provided by (Responsible Party):
Tanja Dujic, PhD, University of Sarajevo

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Omeprazole Drug: Placebo oral tablet Drug: Gliclazide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : August 5, 2019
Actual Study Completion Date : August 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Omeprazole treatment arm
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: Gliclazide
Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.

Placebo Comparator: Placebo treatment arm
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: 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.




Primary Outcome Measures :
  1. Gliclazide AUC [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Glucose [ Time Frame: 12 hours ]
    Change in glucose concentration

  2. Insulin [ Time Frame: 12 hours ]
    Change in insulin concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198948


Locations
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Bosnia and Herzegovina
General Hospital Prim. Dr. Abdulah Nakas
Sarajevo, Bosnia and Herzegovina, 71000
Sponsors and Collaborators
University of Sarajevo
General Hospital Prim. Dr. Abdulah Nakas
University of Dundee
Investigators
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Principal Investigator: Tanja Dujic, PhD University of Sarajevo
Principal Investigator: Aida Kulo Cesic, PhD University of Sarajevo
Publications:

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Responsible Party: Tanja Dujic, PhD, Associate Professor, University of Sarajevo
ClinicalTrials.gov Identifier: NCT04198948    
Other Study ID Numbers: 0101-3678/18
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gliclazide
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs