NCT03361878

Brief Summary

Pharmacokinetic study of metformin intolerance

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started May 2014

Typical duration for phase_4 diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Last Updated

December 5, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 29, 2017

Last Update Submit

November 29, 2017

Conditions

Diabetes Mellitus, Type 2Metformin Adverse Reaction

Keywords

MetforminIntolerancePharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Metformin AUC

    Area under the metformin concentration-time curve

    24 hours

Secondary Outcomes (1)

  • Lactate

    24 hours

Study Arms (2)

Metformin Tolerant

ACTIVE COMPARATOR
Drug: Metformin Hydrochloride

Metformin Intolerant

ACTIVE COMPARATOR
Drug: Metformin Hydrochloride

Interventions

Metformin HydrochlorideDRUG

Single dose of 500mg oral metformin

Metformin IntolerantMetformin Tolerant

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Laura McCreight, MBChB

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two arms - metformin tolerant and metformin intolerant. All participants given single dose of metformin.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 5, 2017

Study Start

May 4, 2014

Primary Completion

May 5, 2016

Study Completion

May 5, 2016

Last Updated

December 5, 2017

Record last verified: 2017-11