A phase IV, randomized, double-blind, placebo-controlled, parallel-group trial to assess the effect of 12-week treatment with the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide or dipeptidyl peptidase-4 inhibitor (DPP-4i) sitagliptin on the cardiovascular, renal and gastrointestinal system in insulin-naïve patients with type 2 diabetes (T2DM). - SAFEGUARD, Pleiotropic effects of incretin based therapies

VU University Medical Center0 sitesNovember 2, 2012

Overview

No summary available.

Registry

who.int

Start Date

November 2, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

VU University Medical Center

•\- Both genders
•\-Age between 35 and 70 years. Females must be post\-menopausal (no menses \>1 year).
•\-Type 2 diabetes (HbA1c 6\.5\-9% DCCT or 48\-75 mmol/mol IFCC), who are being treated with a stable dose of oral antihyperglycemic agents (either metformin alone, SU alone or a combination of metformin and SU) for at least 3 months prior to inclusion.
•\-BMI 25 \- 40 kg/m2
•\- Caucasian
•For the preceding pilot\-study:
•\- Age between 18 and 50 years
•\- BMI 25 – 40 kg/m2
•\- Caucasian
•Are the trial subjects under 18? no

•\- GFR \< 60 mL/min/1\.73m2
•\- Current / chronic use of the following medication: thiazolidinediones, GLP\-1RA, DPP\-4i, glucocorticoids, NSAIDs, insulin, antimicrobial agents, chemotherapeutics or immune suppressants. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study.
•\- History of or actual pancreatic disease or impaired pancreatic exocrine function (defined as needed use of pancreatic enzymes)
•\- Active liver disease or a 3\-fold elevation of liver enzymes (AST / ALT) at screening
•\- History of or actual malignancy (with the exception of basal cell carcinoma)
•\- Current urinary tract infection and active nephritis
•\-Recent (\<6 months) history of cardiovascular disease, including acute coronary syndrome, stroke, transient ischemic neurologic disorder or chronic heart failure (New York Heart Association grade II\-IV)
•\- Current atrial fibrillation
•\- Chronic infectious or auto\-immune disease
•\- Substance and/or alcohol abuse, defined as \>4 units alcohol/day (because of risk of pancreatitis)