Safety Evaluation of Adverse Reactions in Diabetes

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Linagliptin; Drug: Exenatide; Drug: Gliclazide

• Registration Number: NCT02092597
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Primary Completion: 2015-10
• Study Completion: 2016-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPP-4 inhibitor	Linagliptin	Linagliptin 5 mg tbl qd for 3 months
GLP-1 agonist	Exenatide	Exenatide 5 ug s.c. bid for the 1st month, 10 ug s.c. bid for the next 2 months
Sulfonylurea derivate	Gliclazide	Gliclazid 30 mg tbl qd for 3 months

Primary Outcome Measures

Name	Time	Method
Heart rate	90 days after treatment initiation
Pulse wave velocity	90 days after treatment initiation
Tubular function	90 days after treatment initiation
Gastric evacuation velocity	90 days after treatment initiation
Blood pressure	90 days after treatment initiation
Left ventricular ejection fraction	90 days after treatment initiation
Intimomedial thickness	90 days after treatment initiation
Glomerular filtration rate	90 days after treatment initiation
KIM-1	90 days after treatment initiation	Marker of renal damage
Exocrine pancreas function	90 days after treatment initiation

Trial Locations

Locations (1)

General University Hospital; 🇨🇿 Prague, Czechia