Skip to main content
OpenTrials
Completed

NCT Number: NCT02092597

Safety Evaluation of Adverse Reactions in Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General University Hospital

Prague, 128 08, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

exenatide

Drug

Linagliptin

Drug

Gliclazide

Drug

Primary outcomes

  1. Heart rate

    Time frame: 90 days after treatment initiation

  2. Gastric evacuation velocity

    Time frame: 90 days after treatment initiation

  3. Blood pressure

    Time frame: 90 days after treatment initiation

  4. Left ventricular ejection fraction

    Time frame: 90 days after treatment initiation

  5. Intimomedial thickness

    Time frame: 90 days after treatment initiation

  6. Pulse wave velocity

    Time frame: 90 days after treatment initiation

  7. Glomerular filtration rate

    Time frame: 90 days after treatment initiation

  8. Tubular function

    Time frame: 90 days after treatment initiation

  9. KIM-1

    Time frame: 90 days after treatment initiation

    Marker of renal damage

  10. Exocrine pancreas function

    Time frame: 90 days after treatment initiation

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Acronym: SAFEGUARD

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 20, 2014
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.