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
- Conditions
- Type II Diabetes MellitusMedDRA version: 7Level: LLTClassification code 10045242
- Registration Number
- EUCTR2005-001373-97-FI
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4500
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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:<br>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<br>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<br>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;Secondary Objective: Not Applicable;Primary end point(s): None as this is a safety follow-up study
- Secondary Outcome Measures
Name Time Method