Pharmacokinetics of Metformin Intolerance (POMI)

November 29, 2017 updated by: Laura McCreight, NHS Tayside
Pharmacokinetic study of metformin intolerance

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Metformin Tolerant
Drug: Metformin Hydrochloride
Single dose of 500mg oral metformin
ACTIVE_COMPARATOR: Metformin Intolerant
Drug: Metformin Hydrochloride
Single dose of 500mg oral metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metformin AUC
Time Frame: 24 hours
Area under the metformin concentration-time curve
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate
Time Frame: 24 hours
Change in lactate concentration (incremental AUC)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Tayside

Collaborators

University of Southern Denmark
Helmholtz Zentrum München
University of Dundee

Investigators

  • Principal Investigator: Laura McCreight, MBChB, University of Dundee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 4, 2014

Primary Completion (ACTUAL)

May 5, 2016

Study Completion (ACTUAL)

May 5, 2016

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (ACTUAL)

December 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013DM06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Participants have been consented for data sharing. Only anonymised data would be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Metformin Hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe