NCT02092597

Brief Summary

The purpose of this study is to assess the effects of incretin-based antidiabetic therapies (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system and to detail the mechanisms underlying their action in these systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2013

Typical duration for phase_4 type-2-diabetes-mellitus

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

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

March 18, 2014

Last Update Submit

February 6, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (10)

  • Heart rate

    90 days after treatment initiation

  • Gastric evacuation velocity

    90 days after treatment initiation

  • Blood pressure

    90 days after treatment initiation

  • Left ventricular ejection fraction

    90 days after treatment initiation

  • Intimomedial thickness

    90 days after treatment initiation

  • Pulse wave velocity

    90 days after treatment initiation

  • Glomerular filtration rate

    90 days after treatment initiation

  • Tubular function

    90 days after treatment initiation

  • KIM-1

    Marker of renal damage

    90 days after treatment initiation

  • Exocrine pancreas function

    90 days after treatment initiation

Study Arms (3)

GLP-1 agonist

ACTIVE COMPARATOR

Exenatide 5 ug s.c. bid for the 1st month, 10 ug s.c. bid for the next 2 months

Drug: Exenatide

DPP-4 inhibitor

ACTIVE COMPARATOR

Linagliptin 5 mg tbl qd for 3 months

Drug: Linagliptin

Sulfonylurea derivate

ACTIVE COMPARATOR

Gliclazid 30 mg tbl qd for 3 months

Drug: Gliclazide

Interventions

ExenatideDRUG
GLP-1 agonist
LinagliptinDRUG
DPP-4 inhibitor
GliclazideDRUG
Sulfonylurea derivate

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Metformin monotherapy - stable dose during last 3 months
  • HbA1C 48-75 mmol/mol (IFCC)
  • BMI 25-40 kg/m2
  • Age 35-70 years (women postmenopausal)
  • Use of ACE inhibitors or ATII receptor blockers for at least 3 months before enrollment

You may not qualify if:

  • eGFR\<30 ml/min/1.73m2 (MDRD)
  • Treatment with incretin mimetics during 3 months before enrollment
  • Chronic insulin therapy
  • Chronic use of loop diuretics, glucocorticoids, NSAID, immune suppressants, antimicrobial agents, chemotherapeutics, bile acid sequestrants (colestyramin, colesevelam)
  • History of pancreatic disease or impaired pancreatic function (defined as the need to use pancreatic enzymes)
  • Active liver disease or a 3-fold elevation of liver transaminases (ALT, AST)
  • Active malignancy
  • History of severe cardiovascular disease including acute coronary syndrome, stroke or transient ischemic neurologic disorder during previous 6 months, atrial fibrillation or other arrhythmia requiring chronic antiarrhythmic medication, chronic heart failure (New York Heart Association grade III/IV)
  • History of alcohol abuse, defined as \>4 units of alcohol/day (32 g or 40 ml of 100% alcohol)
  • History of allergy for GLP-1 receptor agonists or DPP-4 inhibitors
  • Any disease that could interfere with study procedures (e.g. decreased mobility, mental incapacity)
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital

Prague, 128 08, Czechia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ExenatideLinagliptinGliclazide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolinesBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Martin Haluzik, MD DSc

    3rd Department of Medicine, General University Hospital and Charles University 1st Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 20, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

September 1, 2016

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

CZ(1)