Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of the Weekly Administration of Exenatide LAR or Dulaglutide on the Variability of Blood Pressure and Heart Rate of 24 Hours in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment.
Mortality due to cardiovascular problems is increased by having Diabetes Mellitus type 2
(DM2), related to the time of evolution and glucose levels or if alterations in blood
pressure coexist. With this variability there is greater damage to the target organ and in
patients with DM2 the process is more severe and frequent due to alterations in the
coagulation mechanisms that accelerate in the presence of hypertension, figures ≥135 / 85
mmHg are considered risk factors to develop coronary, cerebral or renal events. As a
quantitative range, blood pressure is currently monitored ambulatory by (MAP) which is the
most used and reliable non-invasive instrument for its evaluation. The American Association
of Clinical Endocrinologists (AACE) proposes an algorithm that contemplates initiating
management to patients with a diagnosis of diabetes with drugs such as metformin,
thiazolidinediones and glucagon-like peptide analogues type 1 (GLP1).
Exenatide LAR and Dulaglutide are GLP-1 analogue drugs with potential to decrease the
progressive losses of pancreatic β cell function and mass and cardiovascular risk (CV)
factors with maintained use, in addition to hypoglycemic, hypotensive effects, weight
decreases and visceral adiposity, however, it has been reported that although they share the
same basic mechanism of action, each one has a different molecular structure and
pharmacokinetic profile that make their pharmacological and clinical effects different, in
particular as regards the variability of blood pressure and heart rate.
A randomized, open clinical trial of 30 patients with a diagnosis of diabetes in accordance
with the American Diabetes Association (ADA) without treatment.
They will be assigned randomly in two groups of 15 patients each to receive 2 mg subcutaneous
of Exenatide LAR (Bydureon by Astra Zeneca) or Dulaglutide .75 mg (trulicity, by Lilly), once
weekly before breakfast during 4 weeks.
There will be calculated body mass index (BMI); low-density lipoprotein cholesterol (LDL-c);
very-low density lipoprotein (VLDL), glomerular filtration rate and blood pressure
variability. This protocol it's already approved by the local ethics committee with number
CEI/447/2017 and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency, dispersion,
average and deviation standard for quantitative variables, frequencies and percentages for
variable qualitative. Qualitative variables will be analyzed by X2, will be used for
differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups
differences. It will be considered statistical significance p ≤0.05.
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