NCT02686177

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started May 2016

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 18, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2017

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

February 15, 2016

Last Update Submit

June 14, 2021

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesAngiogenesisLiraglutideGlucagon like peptide 1 receptor agonist

Outcome Measures

Primary Outcomes (1)

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

    At 1 month

Secondary Outcomes (4)

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

    4 weeks

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

    4 weeks

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

    4 weeks

  • 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)

    4 weeks

Study Arms (2)

1: Liraglutide

EXPERIMENTAL

Liraglutide 1,2 mg once daily subcutaneous injection for 1 month (4 weeks)

Drug: Liraglutide

2: Add on oral antidiabetic medication

ACTIVE COMPARATOR

Metformin or sulfonylurea depending on monotherapy

Drug: Metformin or sulfonylurea

Interventions

LiraglutideDRUG
1: Liraglutide
Metformin or sulfonylureaDRUG
2: Add on oral antidiabetic medication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition department, pole ENDO - Assistance Publique Hôpitaux Marseille

Marseille, 13005, France

Location

Related Publications (1)

  • 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.

    PMID: 31589290DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LiraglutideMetforminSulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsBiguanidesGuanidinesAmidinesOrganic ChemicalsUreaAmidesSulfonesSulfur Compounds

Study Officials

  • Bénédicte GABORIT, MD, PhD

    Assistance Publique - Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 19, 2016

Study Start

May 18, 2016

Primary Completion

August 8, 2017

Study Completion

May 28, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)