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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000045-42 | EudraCT Number |
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| Name | Class |
|---|---|
| ADIR, a Servier Group company | INDUSTRY |
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The purpose of this study is to evaluate the vascular function and biomarkers in healthy volunteers and type 2 diabetic patients.
The present interventional study will be performed in 3 groups of healthy volunteers of different ages and in type 2 diabetic patients without an investigational medicinal product administrated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers aged of 18-30 years | Other |
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| Healthy volunteers aged of 50-59 years | Other |
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| Healthy volunteers aged of 60-70 years | Other |
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| Type 2 diabetic patients aged of 50-70 years | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other | Drug | Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2. Then, subjects will be discharged at the end of the last investigation day (Day 2). All the participants have received two pharmacological agents (NIMP) :
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| Measure | Description | Time Frame |
|---|---|---|
| Guanylate triphosphate cyclohydrolase (GTP-CH) investigations | Plasma/platelet levels of Dihydrobiopterin (BAH)/Tetrahydrobiopterin (BH4), Cyclic guanosine monophosphate (cGMP) | Day 1 |
| Guanylate triphosphate cyclohydrolase (GTP-CH) investigations | Blood flow changes for vascular endothelial function | Day 1 |
| Guanylate triphosphate cyclohydrolase (GTP-CH) investigations | Coronary flow reserve | Day 2 |
| Guanylate triphosphate cyclohydrolase (GTP-CH) investigations | Genomic market (blood) DNA and/or RNA characteristics of genes such as GTP Cyclohydrolase 1 (GCH) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Occurence of any adverse events | Through study completion, 3.5 weeks |
| Blood pressure supine | Relevant abnormalities on supine blood pressure |
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Inclusion Criteria:
Healthy volunteers:
Patients with type 2 diabetes (T2D) mellitus:
Non inclusion Criteria:
Healthy volunteers:
Patients with type II diabetes mellitus (T2D):
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| Name | Affiliation | Role |
|---|---|---|
| Denis Strugala, Dr | Nuvisan GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | 89231 | Germany |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Other | Drug | Type 2 diabetic patients will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and CFR on Day 2. Then, subjects will be discharged at the end of the last investigation day (Day 2). All the participants have received two pharmacological agents (NIMP):
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| Day 1 |
| Study Protocol | View IPD |
| Statistical Analysis Plan | View IPD |
| Informed Consent Form | View IPD |
| Clinical Study Report | View IPD |
| Study-level clinical trial data | View IPD |
| D004700 | Endocrine System Diseases |