Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD)

Charles University, Czech Republic

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Exenatide; Drug: Linagliptin; Drug: Gliclazide

Study type: Interventional

Funder types: Other

Identifiers

NCT02092597

HEALTH-282521-CUNI

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 3 patient groups

GLP-1 agonist

Active Comparator group

Description:

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

Treatment:

Drug: Exenatide

DPP-4 inhibitor

Active Comparator group

Description:

Linagliptin 5 mg tbl qd for 3 months

Treatment:

Drug: Linagliptin

Sulfonylurea derivate

Active Comparator group

Description:

Gliclazid 30 mg tbl qd for 3 months

Treatment:

Drug: Gliclazide