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Clinical Trials/EUCTR2005-000619-85-GB
EUCTR2005-000619-85-GB
Active, Not Recruiting
Phase 1

The relationship between genetic polymorphisms in the organic cation transporter genes and the pharmacokinetics and pharmacodynamics of metformin - The genetics of metformin excretion

The University of Liverpool0 sites200 target enrollmentMay 4, 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type 2 diabetes mellitus
Sponsor
The University of Liverpool
Enrollment
200
Status
Active, Not Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 4, 2005
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
The University of Liverpool

Eligibility Criteria

Inclusion Criteria

  • 1\. Subject is aged between 25 and 85 years of age inclusive.
  • 2\. Subject has given signed informed consent (written and witnessed).
  • 3\. Subject has a diagnosis of type 2 diabetes mellitus, regardless of how and when that diagnosis was established.
  • 4\. Subject’s anti\-hyperglycaemic medication consists of metformin monotherapy, at a dosage of 500mg three times daily and that dosage has been established for a period of at least 3 months.
  • 5\. Subject has not missed any metformin doses for a period of at least 5 days and compliance has been assessed through a validated compliance questionnaire.
  • 6\. Subject is able to recall at least approximate timing of dosing (within 30 minutes).
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • 1\. Subject is, in the opinion of the Investigator, not suitable to participate in the study.
  • 2\. Subject has a diagnosis of pernicious anaemia.
  • 3\. Subject is also prescribed additional anti\-hyperglycaemic medication such as sulphonylureas, meglitinide analogues, thiazolidinediones or insulin.
  • 4\. Subject has taken any known inhibitor of OCT1 or OCT2, such as amantadine, cimetidine, clonidine, desipramine, midazolam, procainamide, quinidine, quinine, or verapamil in the last 4 weeks.
  • 5\. Subject has participated in strenuous physical activity, defined as more than typical walking pace, for a period of 8 hours prior to study entry.
  • 6\. Subject has an alcohol intake greater than the recommended weekly safe drinking limits (\>21 units in men; \>14 units in women).

Outcomes

Primary Outcomes

Not specified

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