Back to resultsSafety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
Exenatide
Linagliptin
Gliclazide
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- General University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
GLP-1 agonist
DPP-4 inhibitor
Sulfonylurea derivate
Arm Description
Exenatide 5 ug s.c. bid for the 1st month, 10 ug s.c. bid for the next 2 months
Linagliptin 5 mg tbl qd for 3 months
Gliclazid 30 mg tbl qd for 3 months
Outcomes
Primary Outcome Measures
Heart rate
Gastric evacuation velocity
Blood pressure
Left ventricular ejection fraction
Intimomedial thickness
Pulse wave velocity
Glomerular filtration rate
Tubular function
KIM-1
Marker of renal damage
Exocrine pancreas function
Secondary Outcome Measures
Full Information
NCT ID
NCT02092597
First Posted
March 18, 2014
Last Updated
February 6, 2018
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT02092597
Brief Title
Safety Evaluation of Adverse Reactions in Diabetes
Acronym
SAFEGUARD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLP-1 agonist
Arm Type
Active Comparator
Arm Description
Exenatide 5 ug s.c. bid for the 1st month, 10 ug s.c. bid for the next 2 months
Arm Title
DPP-4 inhibitor
Arm Type
Active Comparator
Arm Description
Linagliptin 5 mg tbl qd for 3 months
Arm Title
Sulfonylurea derivate
Arm Type
Active Comparator
Arm Description
Gliclazid 30 mg tbl qd for 3 months
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Intervention Type
Drug
Intervention Name(s)
Gliclazide
Primary Outcome Measure Information:
Title
Heart rate
Time Frame
90 days after treatment initiation
Title
Gastric evacuation velocity
Time Frame
90 days after treatment initiation
Title
Blood pressure
Time Frame
90 days after treatment initiation
Title
Left ventricular ejection fraction
Time Frame
90 days after treatment initiation
Title
Intimomedial thickness
Time Frame
90 days after treatment initiation
Title
Pulse wave velocity
Time Frame
90 days after treatment initiation
Title
Glomerular filtration rate
Time Frame
90 days after treatment initiation
Title
Tubular function
Time Frame
90 days after treatment initiation
Title
KIM-1
Description
Marker of renal damage
Time Frame
90 days after treatment initiation
Title
Exocrine pancreas function
Time Frame
90 days after treatment initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Haluzik, MD DSc
Organizational Affiliation
3rd Department of Medicine, General University Hospital and Charles University 1st Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
General University Hospital
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
12. IPD Sharing Statement
Learn more about this trial
Safety Evaluation of Adverse Reactions in Diabetes
We'll reach out to this number within 24 hrs