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Type 2 DiabetesPhase 4ANGIOSAFE 1NCT02686177

Effect of GLP-1 on Angiogenesis

A Phase 4 study testing Liraglutide and Metformin or sulfonylurea in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Liraglutide and Metformin or sulfonylurea
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
18 May 2016to 28 May 2021
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetic patients (ADA criteria)
  • Age > 18 years
  • Obesity (BMI >= 25 kg/m2)
  • HbA1c > 6.5 %
  • Treatment with Metformin and/or secretagogues
  • Effective contraception (women)

Who cannot join

  • Treatment with Exenatide, Liraglutide or other incretinergic regimen (<1 month before recruitment)
  • Type 1 diabetes
  • acute disease or infection
  • chronic renal failure (MDRD eGFR≤50 mL/min)
  • recent cardiovascular event or surgery (<3 months)
  • pancreatitis history
Show all 17Show fewer
  • anti-VEGF treatment
  • untreated cancer
  • immunological disorders
  • pregnancy and lactation
  • Vulnerable people : deprivation of Liberty safeguards
  • hypersensitivity to the active substance or to any of the excipients of the investigational drug
  • diabetic ketoacidosis
  • heart failure stage 3 or 4 (NYHA III-IV)
  • Hepatic insufficiency
  • inflammatory bowel disease and gastroparesis
  • No affiliation to the social security

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nutrition department, pole ENDO - Assistance Publique Hôpitaux Marseille

    Marseille, 13005

Other trials in France

About this study

Official title: Effect of GLP-1 on Angiogenesis, Angiosafe Type 2 Diabetes Study 1

GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.

Read the detailed description

GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. Beside their therapeutic benefits, direct cardiovascular effects have also been reported. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. T2D patients treated with GLP-1 analogs may suffer from microvascular complications such as macular oedema and proliferative retinopathy, characterized by excessive retinal angiogenesis. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The role of GLP-1 on endothelial cell (EC) growth, EC integrity and angiogenesis thus needs to be characterized. Our aim is to provide the proof of concept that agonists of GLP-1 regulate angiogenesis in humans and identify the underlying mechanisms. The present project is the translational part of the ANR Angiosafe-T2D, regarding clinical safety aspects of GLP-1 receptor agonists (namely Liraglutide) on angiogenesis.

The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.

Conditions
Type 2 Diabetes
Being tested
Liraglutide, Metformin or sulfonylurea
Keywords
Type 2 diabetes, Angiogenesis, Liraglutide, Glucagon like peptide 1 receptor agonist
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02686177
Study groupRoleWhat they receive
1: LiraglutideExperimentalLiraglutide 1,2 mg once daily subcutaneous injection for 1 month (4 weeks)
Receives: Drug: Liraglutide
2: Add on oral antidiabetic medicationActive comparatorMetformin or sulfonylurea depending on monotherapy
Receives: Drug: Metformin or sulfonylurea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference of ANGPTL4 concentration at 4 weeks of treatment from baseline in Liraglutide and control group

    Measured: At 1 month

Secondary outcomes (4)

  1. Difference of ANGPT2 concentration at 4 weeks of treatment from baseline in Liraglutide and control group

    We will use commercial ANGPT2 commercial ELISA assays

    Measured: 4 weeks

  2. Difference of endothelial circulating progenitor cells (CD34+KDR+) concentration at 4 weeks of treatment from baseline in Liraglutide and control group

    Circulating progenitor cells (EPCs) will be quantified using flow cytometry before and after one month treatment GLP-1 receptor agonist or reference treatment (control group). Briefly, after erythrocyte lysis, peripheral blood will be stained with 10µL fluorescein isothiocyanate-conjugated anti-human CD34 mAb (Becton Dickinson), 10µL phycoethrin-conjugated anti-human KDR mAb (R\&D Systems), and 10µL allophycocyanin-conjugated anti-CD133 mAb (Miltenyi Biotech). The frequency of CD34+ cells, CD34+ KDR+ cells before and after GLP-1R agonist or control treatment will be determined by a two-dimensional side-scatter fluorescence dot plot analysis after appropriate gating using blood samples from above-stated recruited patients

    Measured: 4 weeks

  3. Difference of AngiomiR-126 expression at 4 weeks of treatment from baseline in Liraglutide and control group

    AngiomiR-126 will be extracted from the fresh isolated cells using the miRNeasy Mini Kit (Qiagen) microRNA expression levels will be compared between type 2 diabetic subjects, before and after one-month GLP-1R agonist treatment and in the control group

    Measured: 4 weeks

  4. Difference of Circulating soluble adhesion molecules as endothelial activation markers: ICAM-1 and VCAM-1 concentration at 4 weeks of treatment from baseline (Liraglutide versus control group)

    The measurement of circulating soluble adhesion molecules as endothelial activation markers: ICAM-1 and VCAM-1 will be done with ELISA commercial assays

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2016 (estimated)
  2. Study start18 May 2016
  3. Primary completion8 Aug 2017
  4. Study completion28 May 2021

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02686177
Sponsor's protocol ID
P140710
Other IDs
2015-002930-35, 2015
Acronym
ANGIOSAFE 1
Status last verified
Jun 2021
First submitted
15 Feb 2016
Last updated
15 Jun 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gaborit B, Julla JB, Besbes S, Proust M, Vincentelli C, Alos B, Ancel P, Alzaid F, Garcia R, Mailly P, Sabatier F, Righini M, Gascon P, Matonti F, Houssays M, Goumidi L, Vignaud L, Guillonneau X, Erginay A, Dupas B, Marie-Louise J, Autie M, Vidal-Trecan T, Riveline JP, Venteclef N, Massin P, Muller L, Dutour A, Gautier JF, Germain S. Glucagon-like Peptide 1 Receptor Agonists, Diabetic Retinopathy and Angiogenesis: The AngioSafe Type 2 Diabetes Study. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz069. doi: 10.1210/clinem/dgz069.

    PubMed 31589290

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide and Metformin or sulfonylurea in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 6 inclusion and 17 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 15 Jun 2021. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Difference of ANGPTL4 concentration at 4 weeks of treatment from baseline in Liraglutide and control group (time frame: At 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02686177, which also lists 1 linked publication.

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 15 Jun 2021.

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