EUCTR2005-001373-97-LT进行中（未招募）不适用
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) - G-PLUS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
研究者
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