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    Summary
    EudraCT Number:2005-001373-97
    Sponsor's Protocol Code Number:D6160C00056
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-29
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedEstonia - SAM
    A.2EudraCT number2005-001373-97
    A.3Full title of the trial
    A Long-Term, Post treatment, Safety Follow-up, Multi-Centre Study in Patients with Type 2 Diabetes Mellitus from the GALLANT, GALLEX or ARMOR Studies, G-PLUS (GALLANT, GALLEX and ARMOR - Post treatment Long-term follow-Up Study)
    A.3.2Name or abbreviated title of the trial where available
    G-PLUS
    A.4.1Sponsor's protocol code numberD6160C00056
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    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.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 II Diabetes Mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate post treatment safety of patients with type 2 diabetes, who received randomized treatment in any of the treatment studies GALLANT, GALLEX or ARMOR by:
    1. evaluating medical events and physical examination at 12 and 24 months post treatment in patients who received treatment for at least 24 weeks in the treatment study or discontinued due to presence of pre-defined labaratory or clinical findings
    2. evaluating 12 weeks post treatment laboratory safety data, adverse events, physical examination and weight in patients who completed a GALLANT study in countries not participating in any of the GALLEX studies
    3. evaluating 12 weeks post treatment laboratory safety data, adverse events, cardiac evaluation, physical examination and weight in patients with pre-defined laboratory or clinical findings
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Based on their inclusion in the short-term follow-up, the patients will be qualified for one of the 2 groups that are described below. Appendix F of the Protocol contains flow charts guiding the inclusion of patients per GALLANT, GALLEX and ARMOR study, respectively.

    Group 1, completing all visits including the short-term follow-up visit: Two categories of patients qualify for inclusion into Group 1, which will have the short-term follow-up visit, i.e. V2. Patients who completed a GALLANT study in a country not participating in any of the GALLEX studies and patients with pre-defined laboratory or clinical findings (criteria 3b-e)). These patients should complete all visits.
    Inclusion criteria applicable for Group 1 at enrolment (visit 1): For inclusion in Group 1 the patient must fulfil all of the following criteria: 1) Provision of informed consent 2)Received any randomized treatment within ARMOR or GALLANT, or participated in a GALLEX study 3)Any of the following: a) Completed a GALLANT study in a country not participating in any of the GALLEX studies b) Met a handling plan-related discontinuation criteria in GALLANT, GALLEX or ARMOR c) Met a criterion for entering a handling plan, or remained in a handling plan at the EoT visit in GALLANT, GALLEX or ARMOR d) Increase in creatinine >50% from baseline to the EoT visit in GALLANT, GALLEX or ARMOR e) Decrease in Hb >2.5 g/dL (25 g/L) from baseline to the EoT visit in GALLANT, GALLEX or ARMOR

    Group 2, completing all visits but the short-term follow-up visit: Patients that received at least 24 weeks of randomized treatment without having any pre-defined laboratory or clinical findings belong to Group 2 and are hence not qualified for the short-term follow-up visit. Patients in Group 2 should complete V1 and V3-V8 (all visits, except V2).
    Inclusion criteria applicable for Group 2 at enrolment (visit 1): For inclusion in Group 2 the patient must fulfil all of the following criteria: 1) Provision of informed consent 2)Any of the following: (a) Completed a GALLANT or ARMOR study but did not enter a GALLEX study (b)Discontinued after the 24-week visit in a GALLANT study (c) Discontinued or completed a GALLEX study.
    After approval and commercial availability of tesaglitazar patients who receive tesaglitazar should not participate in this study. Otherwise there are no restrictions regarding treatment and/or participation in other clinical studies, as long as this is properly recorded in the appropriate section of the eCRF.
    E.4Principal exclusion criteria
    Based on their inclusion in the short-term follow-up, the patients will be qualified for one of the 2 groups that are described above in the inclusion criteria section above.

    Exclusion criteria applicable for Group 1: For patients in Group 1 any of the following is regarded as a criterion for exclusion from the study: 1)Participation in the 12 week follow-up visit within the ARMOR study 2) Discontinued ARMOR or GALLANT due to any other reason than listed in inclusion criterion 3 3)Open label treatment with tesaglitazar (since this is a post treatment study) 4)Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study centre) 5)Previous enrolment in the present study

    Exclusion criteria applicable for Group 2: Any of the following is regarded as a criterion for exclusion from Group 2: 1)Completed a GALLANT study in a country not participating in any of the GALLEX studies 2)Met a handling plan-related discontinuation criteria in GALLANT, GALLEX or ARMOR 3)Met a criterion for entering a handling plan, or remained in a handling plan at the EoT visit in GALLANT, GALLEX or ARMOR 4)Increase in creatinine >50% from baseline to the EoT visit in GALLANT, GALLEX or ARMOR 5)Decrease in Hb >2.5 g/dL (25 g/L) from baseline to the EoT visit in GALLANT, GALLEX or ARMOR 6)Open label treatment with tesaglitazar (since this is a post treatment study) 7)Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study centre) 8)Previous enrolment in the present study
    E.5 End points
    E.5.1Primary end point(s)
    None as this is a safety follow-up study
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Previous treatment is double blind
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of study is defined as date of database lock, which is the time point after which no patient will be exposed to study related activities.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 4500
    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 Decision2006-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-01
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