DIAB-01

WithdrawnPhase 1

Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.

Lead sponsor

Anna Cruceta

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoint

•Endothelial dysfunction

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02109315

Org study IDDIAB-01

Timeline

Milestones

Study first posted2014-04-09estimated

Last update posted2019-02-15actual

Study start2014-05 (month precision)

Primary completion2015-05estimated (month precision)

Study completion2015-05estimated (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed and signed consent obtained before any trial-related activity . ( Trial-related activities are those procedures that were not performed during routine medical examination of the patient) .

•Diagnosis of type 1 diabetes.

•Patients who do not have autonomic dysfunction , defined by ( 1).

•Patients not showing episodes of hypoglycemia unawareness based on the methods of Gold et al (2) .

•Patients without microvascular complications of diabetes.

•Patients without macrovascular complications of diabetes.

•Patients treated with multiple daily injections of insulin.

•No smoking .

•They should have a complete blood count, lipid profile, liver profile , renal profile and plasma electrolyte levels within normal values .

•No subject must have a history of hypertension or taking medication for high blood pressure .

•No subject should be taking medications known to affect the neuroendocrine responses to hypoglycemia or anti inflammatory

Exclusion criteria

•Known or suspected hypersensitivity to study some related products.

•Fertile women, lactating or pregnant, intend to become pregnant or who are not using adequate contraception, or men who have sexually active and are not sterilized surgically, those whose partners are not using a method adequate contraception.

•Clinical diagnosis of Type 2 Diabetes.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Other (unclassified)

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.

Time frame:8 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Oxidative stress markers

Time frame:8 weeks

change from baseline, improvement

componentsnitrotyrosine, 8-iso prostaglandin F2 alpha, sICAM-1, interleukin 6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.