Effect of Exenatide LAR or Dulaglutide on the Variability of 24-hour Heart Rate and Blood Pressure in Type 2 Diabetes

NCT ID: NCT03444142

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2021-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug: Exenatide LAR

Exenatide LAR 2 mg, once weekly subcutaneously before breakfast during 4 weeks.

Group Type: ACTIVE_COMPARATOR

Exenatide LAR

Intervention Type: DRUG

2 mg, once weekly subcutaneously before breakfast during 4 weeks.

Drug: Dulaglutide

Dulaglutide .75 mg, once weekly subcutaneously Before breakfast during 4 weeks.

Group Type: ACTIVE_COMPARATOR

Dulaglutide

Intervention Type: DRUG

.75 mg once weekly subcutaneously before breakfast during 4 weeks.

Interventions

Exenatide LAR

2 mg, once weekly subcutaneously before breakfast during 4 weeks.

Intervention Type: DRUG

Dulaglutide

.75 mg once weekly subcutaneously before breakfast during 4 weeks.

Intervention Type: DRUG

Other Intervention Names

Bydureon; Trulicity

Eligibility Criteria

Inclusion Criteria

• Patients both sexes
• Age between 31 and 60 years
• Diagnosis of diabetes according ADA criteria:

(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%).

• Informed consent signed

Exclusion Criteria

• Women with confirmed or suspected pregnancy
• Women under lactation and/or puerperium
• Hypersensibility to ingredients of intervention
• Physical impossibility for apply the drug
• Known pancreatic, renal, hepatic, heart or thyroid diseased
• Hypertension diagnosis
• Previous treatment for glucose
• Body Mass Index ≥39.9 kg/m2
• Triglycerides ≥500 mg/dL
• Total cholesterol ≥300 mg/dL
• Night or rotating shift workers
• Blood Pressure ≥140/90 mmHg

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Manuel González Ortiz

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MANUEL GONZALEZ, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

Instituto de terapeutica Experimental y Clinica. Centro universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

MANUEL GONZALEZ, PhD

Role: CONTACT

uiec@prodigy.net.mx

+523310585200 ext. 34212

KARINA PEREZ, PhD

Role: CONTACT

karina2410@hotmail.com

+523310585200 ext. 34212

Other Identifiers

Exenatida LAR Dulaglutida-with

Identifier Type: -

Identifier Source: org_study_id