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Pharmacokinetics of Metformin Intolerance

NCT ID: NCT03361878

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-04

Study Completion Date

2016-05-05

Brief Summary

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Pharmacokinetic study of metformin intolerance

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Metformin Adverse Reaction

Keywords

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Metformin Intolerance Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metformin Tolerant

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride

Intervention Type DRUG

Single dose of 500mg oral metformin

Metformin Intolerant

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride

Intervention Type DRUG

Single dose of 500mg oral metformin

Interventions

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Metformin Hydrochloride

Single dose of 500mg oral metformin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

University of Dundee

OTHER

Sponsor Role collaborator

Helmholtz Zentrum München

INDUSTRY

Sponsor Role collaborator

NHS Tayside

OTHER_GOV

Sponsor Role lead

Responsible Party

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Laura McCreight

Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura McCreight, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Other Identifiers

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2013DM06

Identifier Type: -

Identifier Source: org_study_id