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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

Tracking Information
First Submitted Date  ICMJE December 11, 2019
First Posted Date  ICMJE December 13, 2019
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE March 4, 2019
Actual Primary Completion Date August 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
Gliclazide AUC [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Glucose [ Time Frame: 12 hours ]
    Change in glucose concentration
  • Insulin [ Time Frame: 12 hours ]
    Change in insulin concentration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Official Title  ICMJE Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Omeprazole
    • Drug: Gliclazide
  • 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.
    Interventions:
    • Drug: Placebo oral tablet
    • Drug: Gliclazide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2019)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 5, 2019
Actual Primary Completion Date August 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bosnia and Herzegovina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04198948
Other Study ID Numbers  ICMJE 0101-3678/18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tanja Dujic, PhD, University of Sarajevo
Study Sponsor  ICMJE University of Sarajevo
Collaborators  ICMJE
  • General Hospital Prim. Dr. Abdulah Nakas
  • University of Dundee
Investigators  ICMJE
Principal Investigator: Tanja Dujic, PhD University of Sarajevo
Principal Investigator: Aida Kulo Cesic, PhD University of Sarajevo
PRS Account University of Sarajevo
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP