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Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus
Servier Protocol Code:
CL1-RTCMP-001
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT04744636
EudraCT Number:
2017-000045-42
Find a recruiting site
How to participate to the study?
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 1 location
Study description
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.
Official title: Target Involvement and Exploratory Biomarkers Investigations in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus
Results
English (USA)Conditions
Type 2 Diabetes Mellitus
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Other
Other study id numbers
Other identification numbers the study may be known by.
- CL1-RTCMP-001
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years to 70 years
(Adult, Older Adult)
Sexes
Male/FemaleAccepts Healthy Volunteers
Yes- Healthy volunteers:
- * Age [18 -30], [50-59] and [60-70] years
- * Male and female healthy volunteers, except with skin types 5 and 6
- * Body weight ≥ 50 kg and BMI between [18.0 -28.0] kg/m^2 inclusive
- * Non or ex-smokers (defined as someone who completely stopped smoking for at least 1 month before the beginning of this study)
- * No clinically relevant findings in the medical history and physical examination, especially with regards to cardiovascular system, lung, liver and renal function
- * Normal blood and urine laboratory tests
- Patients with type 2 diabetes (T2D) mellitus:
- * Male and female patients, except with skin types 5 and 6
- * Age [50 - 70] years
- * BMI ≤35 kg/m2
- * T2D patients (according to American Diabetes Association (ADA) criteria i.e. HbA1c > 6.5% or fasting plasma glucose > 126 mg/dL (7.00 mmol/L) or 2-hour glucose ≥ 200mg/dL (11.1mmol/L) after 75g oral glucose or glucose ≥200mg/dL (11.1mmol/L) at any time on two separate occasions (historic values and/or at selection)
- * Currently treated with Standards of Medical Care in T2D at stable doses for at least 3 months
- * Antihypertensive drugs allowed except beta-blockers and calcium antagonists
- * Non or ex-smokers (defined as someone who completely stopped smoking for at least 1 month before the beginning of this study)
- Healthy volunteers:
- * Unlikely to co-operate in the study,
- * Participation in another interventional study, including last study drug intake, at the same time or within the 3 months preceding the selection visit; participation in non-interventional registries or epidemiological studies is allowed,
- * Deprived of his freedom by administrative or court order or under guardianship,
- * History or evidence of acute or chronic abuse of alcohol consumption of> 21 alcohol units per week for males and >14 units per week for females (1 alcohol unit = 100 mL of 12% wine; = 30 mL of 40% spirits; = 250 mL of 6% beer),
- * Positive alcohol breath test,
- * Positive cotinine test,
- * Known or suspected to be drug-dependent,
- * Positive result in urinary screening for drug abuse,
- * Pregnancy, breastfeeding or lactating,
- * Regular use of prescribed and non-prescribed drugs in the last 60 days before the day of investigations into the study except hormonal contraception (e.g. pill or hormonal intrauterine device (IUD) or hormonal implants or Nuva Ring) (if applicable),
- * Any drug intake of prescribed or non-prescribed drugs including over-counter drugs (except acetaminophen), herbal remedies or nutritional supplements such as multivitamins in the 2 weeks before the day of investigations unless the investigator deems this drug intake to be irrelevant for the purpose of this study and that can be temporarily suspended,
- * Intake of dipyridamol (contraindicated with adenosine infusion)
- * Known hypersensitivity to adenosine injection,
- * Any acute or chronic illness or clinically relevant findings (i.e. liver, kidney, cardiovascular diseases) in the selection visit examinations,
- Patients with type II diabetes mellitus (T2D):
- * Unlikely to co-operate in the study,
- * Participation in another interventional study, including last study drug intake, at the same time or within the 3 months preceding the selection visit; participation in non-interventional registries or epidemiological studies is allowed,
- * Deprived of his freedom by administrative or court order or under guardianship,
- * Unwilling to allow his or her primary care practitioner to be notified of participation in the study and for information on a participant's medical history to be obtained from the general practitioner,
- * History or evidence of acute or chronic abuse of alcohol consumption of> 21 alcohol units per week for males and >14 units per week for females (1 alcohol unit = 100 mL of 12% wine; = 30 mL of 40% spirits; = 250 mL of 6% beer),
- * Positive alcohol breath test,
- * Positive cotinine test,
- * Known or suspected to be drug-dependent,
- * Positive result in urinary screening for drug abuse,
- * Pregnancy, breastfeeding or lactating,
- * Intake of dipyridamol (contraindicated with adenosine infusion)
- * Known hypersensitivity to adenosine injection,
- * Any acute or chronic illness or clinically relevant findings (i.e. liver,kidney, cardiovascular diseases) in the selection visit examinations.
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Other:
Healthy volunteers aged of 18-30 years
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Other
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) :
* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
* Adenosine : administered intravenously during MRI for the measurement of CFR.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Other:
Healthy volunteers aged of 50-59 years
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Other
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) :
* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
* Adenosine : administered intravenously during MRI for the measurement of CFR.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Other:
Healthy volunteers aged of 60-70 years
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Other
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) :
* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
* Adenosine : administered intravenously during MRI for the measurement of CFR.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Other:
Type 2 diabetic patients aged of 50-70 years
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Other
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):
* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
* Adenosine : administered intravenously during MRI for the measurement of CFR.
Keywords
Provided by Servier
Type 2 diabetes mellitus
Phase 1
Healthy volunteers
Clinical translational exploratory study
Target involvement
Exploratory biomarkers
Cardiovascular disease
Vascular function
Coronary flow reserve
Biopterins
Cutaneous blood flow
Additional Relevant MeSH Terms Glioma
Diabetes Mellitus, Type 2
Cardiovascular Diseases