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
ConditionsType 2 diabetes mellitus
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.
Investigators
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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