Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effects on Insulin Resistance With the Phosphodiesterase-5 Inhibitor Tadalafil in Type 2 Diabetes - a Double-blind, Placebo-controlled Crossover Study
The aim is to continue our program on PDE5 inhibition by evaluating effects on insulin
resistance, including glucose metabolism and subclinical inflammation, after a 6-week
administration of tadalafil in T2D patients. The primary objective is to study the effect of
tadalafil compared with placebo on insulin sensitivity during a euglycemic hyperinsulinemic
clamp.
This is a double-blind, placebo-controlled crossover study with one study site. Twenty-five
T2D patients will be recruited and randomized to per oral intake of tadalafil 20 mg o.d. for
six weeks and after a wash-out period of eight weeks intake of placebo for another six weeks,
or vice versa. At the end of each 6 week treatment period a glucose clamp, subcutaneous
needle biopsies as well as muscle and subcutaneous microdialysis will be performed.
Endothelial function tests and arginin stimulation of insulin secretion tests will be
performed after 3 weeks in each treatment arm.
n/a
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