Phase 1 Completed N=15 Randomized Single-blind Basic Science

Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT04198948 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcomePrimary: Gliclazide AUC — 3.73; 3.29 μgh/mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Gliclazide AUC	3.73; 3.29	—
SECONDARY Glucose	4.6; 4.0	0.636
SECONDARY Insulin	231.6; 265.9	0.055

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT04198948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.