Pharmacokinetics of Metformin Intolerance

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03361878

Acronym

POMI

Enrollment

Registered

2017-12-05

Start date

2014-05-04

Completion date

2016-05-05

Last updated

2017-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Metformin Adverse Reaction

Keywords

Metformin, Intolerance, Pharmacokinetics

Brief summary

Pharmacokinetic study of metformin intolerance

Detailed description

This pharmacokinetic study recruited white European individuals with type 2 diabetes, who had previously been exposed to metformin and met the criteria for tolerance or intolerance. Intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for up to 8 weeks) but discontinued treatment with patient reported or documentation of gastrointestinal upset, leading to discontinuation (Criterion 1). Alternatively, intolerance was defined as inability to increase metformin dose above 500mg without experiencing gastrointestinal side-effects, despite having an HbA1c \>53mmol/mol (Criterion 2). Tolerant individuals were defined as those taking 2000mg metformin daily in divided doses, with no side effects. Ten tolerant and ten intolerant individuals were recruited. Participants gave written consent. They attended the research centre fasted from midnight. A baseline blood test was taken before a single dose of oral metformin was administered at 0900, with further bloods taken at 11 time points over the following 24 hours. A 24 hour urine collection was completed. Blood samples were analysed for plasma metformin, and serum lactate concentrations.

Interventions

DRUGMetformin Hydrochloride

Single dose of 500mg oral metformin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Two arms - metformin tolerant and metformin intolerant. All participants given single dose of metformin.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* White European * Type 2 diabetes * Meet criteria for tolerance or intolerance as described

Exclusion criteria

* Estimated glomerular filtration rate (eGFR) \<60 * Cognitive impairment * Pregnancy * Concurrent treatment with: acarbose, cephalexin, cimetidine, pyrimethamine, or tyrosine kinase inhibitors * History of gastric bypass * Evidence of slowed gastric or intestinal motility

Design outcomes

Primary

Measure	Time frame	Description
Metformin AUC	24 hours	Area under the metformin concentration-time curve

Secondary

Measure	Time frame	Description
Lactate	24 hours	Change in lactate concentration (incremental AUC)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026