The aim of this study is to detail the (mechanisms underlying the) actions of the GLP-1
receptor agonists and DPP-4 inhibitors on the cardiovascular, renal and gastrointestinal
systems in patients with Type 2 Diabetes Mellitus.
Drug: Liraglutide placebo
Drug: Sitagliptin placebo
Drug: Exenatide placebo
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Full eligibility criteria for NCT01744236
Ages eligible for Study
35 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age between 35 and 75 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
Signed informed consent
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
Active liver disease
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
History of allergy/hypersensitivity to any of the test agents
Complaints compatible with or established gastroparesis and/or neurogenic bladder
Any condition that has been recognized as a contra-indication for the use of GLP-1RA and DPP-4i, as listed in the respective SPCs
History of or actual (severe) mental illness
Inability to understand the study protocol and/or inability to give informed consent
History of claustrophobia or presence of metal objects/implants (because of MRI protocol) For the preceding Pilot study, we will include:
Age between 18 and 50 years
BMI 25 - 40 kg/m2
Caucasian The exclusion criteria for the preceding pilot study are similar to the exclusion criteria of the main study, with the additions of:
Subjects with a fasting plasma glucose ≥5.6 mmol/L, a 2-hour glucose of ≥7.8 mmol/L after a 75-grams oral glucose tolerance test, or a HbA1c of ≥6.5%
Subjects using any kind of medication
All locations for NCT01744236
VU University Medical Center
Amsterdam, Netherlands, 1081HV
View full eligibility
Tris trial is registered with FDA with number: NCT01744236. The sponsor of the trial is VU University Medical Center and it is looking for 70 volunteers for the current phase.
Official trial title: 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).
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