A Phase 4 interventional study of Exenatide LAR and Dulaglutide in Diabetes Mellitus, Type 2, sponsored by University of Guadalajara. Status unknown at 1 site in Mexico. Open to participants aged 31 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by University of Guadalajara · Phase 4, Interventional, and 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.
(Fasting blood glucose levels >125 mg/dl or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose > 200 mg/dl, or glycosylated hemoglobin >6.5%).
Exclusion Criteria:
Exenatide LAR 2 mg, once weekly subcutaneously before breakfast during 4 weeks.
Drug: Exenatide LAR
Dulaglutide .75 mg, once weekly subcutaneously Before breakfast during 4 weeks.
Drug: Dulaglutide
2 mg, once weekly subcutaneously before breakfast during 4 weeks.
Also known as: Bydureon
.75 mg once weekly subcutaneously before breakfast during 4 weeks.
Also known as: Trulicity
Heart rate: nighttime, daytime and 24-h
heart rate variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3
Time frame: Baseline to Week 4
Systolic blood pressure, daytime, night and 24 h
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O33.
Time frame: Baseline to Week 4
Diastolic blood pressure, daytime, night and 24 h
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3
Time frame: Baseline to Week 4
Blood pressure
Blood pressure will be measured at baseline and week 4 with a digital sphygmomanometer and the entered values reflect the blood pressure.
Time frame: Baseline to Week 4
Categories: dipper o non dipper
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hrs by oscillometric method Microlife WatchBP O3
Time frame: Baseline to Week 4
Fasting glucose levels
The fasting glucose levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 4
Time frame: Baseline to Week 4
Central and peripheral blood pressure
To determine and compare the effect of administration of Exenatide LAR or Dulaglutide on Central and peripheral blood pressure through HEM will be evaluated at baseline and week 4.
Time frame: Baseline to Week 4
Pulse wave velocity
To determine and compare the effect of administration of Exenatide LAR or Dulaglutide on pulse wave velocity through VP1000-plus with Ankle-Brachial Index will be evaluated at baseline and week 4.
Time frame: Baseline to Week 4
Cardio-ankle Vascular Index (CAVI)
To determine and compare the effect of administration of Exenatide LAR or Dulaglutide on arterial stiffness through Cardio-ankle Vascular Index (CAVI) will be evaluated at baseline and week 4.
Time frame: Baseline to Week 4
Glycosylated hemoglobin
Glycosylated hemoglobin will be evaluated at baseline and week 4 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 4
Time frame: Baseline to Week 4
Body Weight
The body weight will be measured at baseline and week 4 with a bioimpedance balance and the entered values reflect the body weight at week 4
Time frame: Baseline to Week 4
Body Mass Index
Body Mass Index will be calculated at baseline and week 4 with the Quetelet index formula and the entered values reflect the body mass index at week 4
Time frame: Baseline to Week 4
Total cholesterol
Total cholesterol levels will be evaluated at baseline and week 4 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 4
Time frame: Baseline to Week 4
Triglycerides levels
Triglycerides levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 4
Time frame: Baseline to Week 4
High density lipoprotein (c-HDL) levels
c-HDL levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 4
Time frame: Baseline to Week 4
Alanine aminotransferase (ALT) levels
ALT levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques
Time frame: Baseline to Week 4
Aspartate aminotransferase (AST) levels
AST levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques \[Time Frame: Baseline to Week 4
Time frame: Baseline to Week 4
Creatinine levels
Creatinine levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques
Time frame: Baseline to Week 4
Uric acid levels
Uric acid levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques
Time frame: Baseline to Week 4
Waist Circumference
Waist circumference will be evaluated at baseline and at week 4 with a flexible tape
Time frame: Baseline, week 4
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Guadalajara