Type 2 Diabetes Clinical Trial
Official 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).
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.
GLP-1 receptors are present in most organ systems of the human body, and pharmacological
interventions enhancing GLP-1 activity may influence the function of these organs. The use
of GLP-1 receptor agonists (GLP-1RA) and DPP-4 inhibitors (DPP-4i) has been associated with
an increased heart rate, acute pancreatitis and acute renal failure. To date, studies in
humans detailing the effects of these drugs on these organ systems, biological processes and
underlying mechanisms, which could explain these associations, are lacking.
Therefore, as part of the EU-FP7 SAFEGUARD program, the present study will aim to detail the
(mechanisms underlying the) actions of GLP-1RA and DPP-4i on the cardiovascular, renal and
gastrointestinal system in healthy obese subjects and patients with T2DM.
In the main study, sixty patients with type 2 diabetes will undergo two interventions within
the same protocol in order to assess changes in the outcome parameters:
- acute study = acute infusion with exenatide or placebo (to assess the cardiovascular
and renal effects)
- long-term study = 12 weeks of treatment with liraglutide, sitagliptin or placebo (to
assess the cardiovascular, renal and gastrointestinal effects)
In a substudy (termed 'acute MRI study'), twelve patients with type 2 diabetes will undergo
an additional acute intervention study with exenatide (to assess the pancreatic effects)
In a substudy (termed 'pilot-study'), ten healthy obese subjects will undergo a similar
acute study like the patients with type 2 diabetes (to assess the cardiovascular and renal
effects). Moreover, in these healthy subjects, the effects of exenatide during L-NMMA
infusion will be assessed.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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