Type 2 Diabetes MellitusPhase 1NCT04744636
Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing Other in people with Type 2 Diabetes Mellitus, run by Institut de Recherches Internationales Servier at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the vascular function and biomarkers in healthy volunteers and type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Other
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 3 Apr 2017to 15 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 45Show fewer
- 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)
- Non inclusion Criteria:
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Target Involvement and Exploratory Biomarkers Investigations in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the vascular function and biomarkers in healthy volunteers and type 2 diabetic patients.
Read the detailed 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Other
- Keywords
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherDrug
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.
OtherDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers aged of 18-30 years | Other | Not described Receives: Drug: Other |
| Healthy volunteers aged of 50-59 years | Other | Not described Receives: Drug: Other |
| Healthy volunteers aged of 60-70 years | Other | Not described Receives: Drug: Other |
| Type 2 diabetic patients aged of 50-70 years | Other | Not described Receives: Drug: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Plasma/platelet levels of Dihydrobiopterin (BAH)/Tetrahydrobiopterin (BH4), Cyclic guanosine monophosphate (cGMP)
Measured: Day 1
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Blood flow changes for vascular endothelial function
Measured: Day 1
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Coronary flow reserve
Measured: Day 2
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Genomic market (blood) DNA and/or RNA characteristics of genes such as GTP Cyclohydrolase 1 (GCH)
Measured: Day 1
Secondary outcomes (2)
Adverse events
Occurence of any adverse events
Measured: Through study completion, 3.5 weeks
Blood pressure supine
Relevant abnormalities on supine blood pressure
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start3 Apr 2017
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
- Investigators
- Denis Strugala, Dr, Principal investigator, Nuvisan GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744636
- Sponsor's protocol ID
- CL1-RTCMP-001
- Other IDs
- 2017-000045-42, 2017
- Status last verified
- Jul 2024
- First submitted
- 27 Jan 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Involvement and Exploratory Biomarkers Investigations in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04744636
- Acronym / sponsor ID
- CL1-RTCMP-001
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Phase 1, Healthy volunteers, Clinical translational exploratory study, Target involvement, Exploratory biomarkers, Cardiovascular disease, Vascular function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the vascular function and biomarkers in healthy volunteers and type 2 diabetic patients.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers aged of 18-30 years | Other | Drug: Other |
| Healthy volunteers aged of 50-59 years | Other | Drug: Other |
| Healthy volunteers aged of 60-70 years | Other | Drug: Other |
| Type 2 diabetic patients aged of 50-70 years | Other | Drug: Other |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtherHealthy 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. | Drug | Healthy volunteers aged of 18-30 years, Healthy volunteers aged of 50-59 years, Healthy volunteers aged of 60-70 years |
| OtherType 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. | Drug | Type 2 diabetic patients aged of 50-70 years |
Primary outcome
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Time frame: Day 1
Plasma/platelet levels of Dihydrobiopterin (BAH)/Tetrahydrobiopterin (BH4), Cyclic guanosine monophosphate (cGMP)
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Time frame: Day 1
Blood flow changes for vascular endothelial function
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Time frame: Day 2
Coronary flow reserve
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Time frame: Day 1
Genomic market (blood) DNA and/or RNA characteristics of genes such as GTP Cyclohydrolase 1 (GCH)
2 secondary outcomes
Adverse events
Time frame: Through study completion, 3.5 weeks
Blood pressure supine
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Yes. 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: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Strugala, Dr principal investigator
Nuvisan GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Other in people with Type 2 Diabetes Mellitus, run by Institut de Recherches Internationales Servier at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.