E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study involves patients with type 2 Diabetes and Peripheral Arterial Disease.The overall objective of the research proposal is to determine the occurrence of biomarkers that typify the metabolic syndrome in patients with peripheral vascular diseases.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The overall objective of the research proposal is to determine the occurrence of biomarkers with proven links to future Cardiovascular events in patients with Peripheral Arterial Disease (PAD)and type 2 diabetes receiving various standards of care medicines including pioglitazone. |
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E.2.2 | Secondary objectives of the trial |
Pre-Intervention Stage: 1. Identify biomarkers for improved vascular health 2. Transcriptional mRNA profiling of peripheral blood leukocytes from patients with PAD in reference to standard treatment 3. Transcriptional gene and protein profiling in muscle of PAD patients in resting and in exercise
Intervention Stage: 4. Correlate clinical parameters (e.g. walking distances) in patients with Peripheral Arterial Disease (PAD) and type 2 diabetes treated with various standard of care medicines to genes and protein profiling in muscle biopsies. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For Pre-Intervention stage of the study subjects with Peripheral Arterial Disease (PAD)and type 2 Diabetes will be included. PAD will be defined as patients with classical symptoms of intermittent claudication plus an ankle brachial blood pressure index (ABPI) of <0.9, the accepted cut off level for such a diagnosis.
We are amending our inclusion criteria and will also be including patients with toe-brachial pressure index (TBI) of <0.70. This measurement will be used in patients who have high ABPI >1.1 due to non-compressible arteries. This validated measurement has previously been used in Genzyme WALK study which is an International Gene Therapy trial in PAD patients. There is no clinical contraindication for these patients. This will help us in recruitment.
We are also submitting a poster about the study which we will display around the hospital for advertisement of the study.
For Intervention stage of the study patients with short distance claudication (<200yards) will be selected for the walking study , as their walking distances are more reproducible, ( ie using the standardized Gardner walking treadmill protocol no more than 25% variation from 2 consecutive treadmill tests performed at least a week apart during the Screening period). Patients for this 2nd study will be type 2 diabetic patients not receiving insulin. |
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E.4 | Principal exclusion criteria |
1. Contraindication to thiazolidinedione group of drugs. 2. Subjects taking Sulphonylureas 3. Subjects with Cardiovascular disease event within last three months like MI, unstable angina, stroke. 4. For Phase 2 study, subjects having more than 25% variation from 2 consecutive treadmill tests performed atleast a week apart. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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Last visit of the subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |