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OpenTrials
Completed

NCT Number: NCT04198948

Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

General Hospital Prim. Dr. Abdulah Nakas

Sarajevo, 71000, Bosnia and Herzegovina

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole

Drug

Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.

Placebo oral tablet

Drug

Placebo will be administered orally once daily for 5 days in one of the two treatment periods.

Gliclazide

Drug

Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.

Primary outcomes

  1. Gliclazide AUC

    Time frame: 24 hours

    Area under the concentration-time curve (AUC) up to the last concentration measured

Secondary outcomes

  1. Glucose

    Time frame: 12 hours

    Change in glucose concentration - incremental area under the glucose concentration-time curve from 0 to 12 h

  2. Insulin

    Time frame: 12 hours

    Change in insulin concentration - incremental area under the insulin concentration-time curve from 0 to 12 h

Sponsors and collaborators

Lead sponsor

University of Sarajevo

Other

Collaborators

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

Registry information

Acronym: INTERGLIKOM

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2019
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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