Type 2 Diabetes MellitusPhase 4SAFEGUARDNCT02092597
Safety Evaluation of Adverse Reactions in Diabetes
A Phase 4 study testing Exenatide, Linagliptin and Gliclazide in people with Type 2 Diabetes Mellitus, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Exenatide, Linagliptin and Gliclazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCzechia
- Study dates
- Oct 2013to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Exenatide, Linagliptin, Gliclazide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
LinagliptinDrug
GliclazideDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Exenatide |
| DPP-4 inhibitor | Active comparator | Linagliptin 5 mg tbl qd for 3 months Receives: Drug: Linagliptin |
| Sulfonylurea derivate | Active comparator | Gliclazid 30 mg tbl qd for 3 months Receives: Drug: Gliclazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: 90 days after treatment initiation
Gastric evacuation velocity
Measured: 90 days after treatment initiation
Blood pressure
Measured: 90 days after treatment initiation
Left ventricular ejection fraction
Measured: 90 days after treatment initiation
Intimomedial thickness
Measured: 90 days after treatment initiation
Pulse wave velocity
Measured: 90 days after treatment initiation
Glomerular filtration rate
Measured: 90 days after treatment initiation
Tubular function
Measured: 90 days after treatment initiation
KIM-1
Marker of renal damage
Measured: 90 days after treatment initiation
Exocrine pancreas function
Measured: 90 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Haluzik, Charles University, Czech Republic
- Investigators
- Martin Haluzik, MD DSc, Principal investigator, 3rd Department of Medicine, General University Hospital and Charles University 1st Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092597
- Sponsor's protocol ID
- HEALTH-282521-CUNI
- Acronym
- SAFEGUARD
- Status last verified
- Feb 2018
- First submitted
- 18 Mar 2014
- Last updated
- 7 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of Adverse Reactions in Diabetes
- ClinicalTrials.gov ID
- NCT02092597
- Acronym / sponsor ID
- SAFEGUARD / HEALTH-282521-CUNI
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLP-1 agonist | Active comparator | Drug: ExenatideExenatide 5 ug s.c. bid for the 1st month, 10 ug s.c. bid for the next 2 months |
| DPP-4 inhibitor | Active comparator | Drug: LinagliptinLinagliptin 5 mg tbl qd for 3 months |
| Sulfonylurea derivate | Active comparator | Drug: GliclazideGliclazid 30 mg tbl qd for 3 months |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide | Drug | GLP-1 agonist |
| Linagliptin | Drug | DPP-4 inhibitor |
| Gliclazide | Drug | Sulfonylurea derivate |
Primary outcome
Heart rate
Time frame: 90 days after treatment initiation
Gastric evacuation velocity
Time frame: 90 days after treatment initiation
Blood pressure
Time frame: 90 days after treatment initiation
Left ventricular ejection fraction
Time frame: 90 days after treatment initiation
Intimomedial thickness
Time frame: 90 days after treatment initiation
Pulse wave velocity
Time frame: 90 days after treatment initiation
Glomerular filtration rate
Time frame: 90 days after treatment initiation
Tubular function
Time frame: 90 days after treatment initiation
KIM-1
Time frame: 90 days after treatment initiation
Marker of renal damage
Exocrine pancreas function
Time frame: 90 days after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Haluzik, MD DSc principal investigator
3rd Department of Medicine, General University Hospital and Charles University 1st Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exenatide, Linagliptin and Gliclazide in people with Type 2 Diabetes Mellitus, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 90 days after treatment initiation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.