Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2013-10-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GLP-1 agonist
Exenatide 5 ug s.c. bid for the 1st month, 10 ug s.c. bid for the next 2 months
Exenatide
DPP-4 inhibitor
Linagliptin 5 mg tbl qd for 3 months
Linagliptin
Sulfonylurea derivate
Gliclazid 30 mg tbl qd for 3 months
Gliclazide
Interventions
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Exenatide
Linagliptin
Gliclazide
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
35 Years
70 Years
ALL
No
Sponsors
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Charles University, Czech Republic
OTHER
Responsible Party
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Martin Haluzik
Professor
Principal Investigators
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Martin Haluzik, MD DSc
Role: PRINCIPAL_INVESTIGATOR
3rd Department of Medicine, General University Hospital and Charles University 1st Faculty of Medicine
Locations
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General University Hospital
Prague, , Czechia
Countries
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Other Identifiers
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HEALTH-282521-CUNI
Identifier Type: -
Identifier Source: org_study_id
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