Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus

NCT04744636 | Completed Phase 1

• 2 other identifiers: CL1-RTCMP-0012017-000045-42
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the vascular function and biomarkers in healthy volunteers and type 2 diabetic patients.

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; Coronary flow reserve; Biopterins; Cutaneous blood flow

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• Adverse events

  Through study completion, 3.5 weeks

• Blood pressure supine

  Day 1

Study Arms (4)

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

Interventions

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) : * Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function. * Adenosine : administered intravenously during MRI for the measurement of CFR.

Healthy volunteers aged of 18-30 years; Healthy volunteers aged of 50-59 years; Healthy volunteers aged of 60-70 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead
• ADIR, a Servier Group company: collaborator

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Denis Strugala, Dr

  Nuvisan GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 9, 2021
• Study Start: April 3, 2017
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• Access Criteria: 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.

Locations

DE (1)