Kliniska prövningar Nct sida

Summary
EudraCT Number:2005-000619-85
Sponsor's Protocol Code Number:2937
National Competent Authority:UK - MHRA
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2005-05-04
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedUK - MHRA
A.2EudraCT number2005-000619-85
A.3Full title of the trial
The relationship between genetic polymorphisms in the organic cation transporter genes and the pharmacokinetics and pharmacodynamics of metformin
A.3.2Name or abbreviated title of the trial where available
The genetics of metformin excretion
A.4.1Sponsor's protocol code number2937
A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot applicable
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorThe University of Liverpool
B.1.3.4CountryUnited Kingdom
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
B.Sponsor: 2
B.1.1Name of SponsorThe Royal Liverpool and Broadgreen University Hospitals NHS Trust
B.1.3.4CountryUnited Kingdom
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Metformin (Glucophage)
D.2.1.1.2Name of the Marketing Authorisation holderLipha Pharmaceuticals Limited
D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameMetformin
D.3.2Product code Metformin
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNMetformin
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number500
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Type 2 diabetes mellitus
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To characterise the relationship between plasma metformin pharmacokinetics and the presence of polymorphisms in human organic cation transporter genes in patients with type 2 diabetes mellitus on chronic metformin therapy.
E.2.2Secondary objectives of the trial
To characterise the relationship between the plasma pharmacokinetics and the levels of vitamin B12 and lactate in patients with type 2 diabetes mellitus on chronic metformin therapy.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal 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).
E.4Principal 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).
E.5 End points
E.5.1Primary end point(s)
1. OCT1 and OCT2 genotype
Identification of the following SNPs will be undertaken:
a) OCT1-M408V
b) OCT1-M420del
c) OCT1-R61C
d) OCT2-A270S
2. Metformin pharmacokinetic (PK) parameters:
a) Plasma metformin concentration (co-primary outcome measure)
b) Predicted metformin clearance (co-primary outcome measure)
c) Predicted metformin AUC (area under the plasma concentration-time curve)
d) Predicted metformin Cmax
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Yes
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
Observational
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
Not applicable
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years3
E.8.9.2In all countries concerned by the trial months0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state200
F.4.2 For a multinational trial
F.4.2.1In the EEA 200
F.4.2.2In the whole clinical trial 200
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
No change to expected normal treatment of condition.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2005-05-25
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-03-23
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2009-05-01

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