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

Sponsor
University of Guadalajara
Study ID
NCT03444142
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
31 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Exenatide LAR — DRUG
    2 mg, once weekly subcutaneously before breakfast during 4 weeks.
  • Dulaglutide — DRUG
    .75 mg once weekly subcutaneously before breakfast during 4 weeks.

Study Details

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.

Key Dates

Start date
Nov 17, 2017
Status verified
Mar 2020
Primary completion
Nov 30, 2021
Completion
Nov 30, 2021

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Drug: Exenatide LAR
    Exenatide LAR 2 mg, once weekly subcutaneously before breakfast during 4 weeks.
  • Active Comparator: Drug: Dulaglutide
    Dulaglutide .75 mg, once weekly subcutaneously Before breakfast during 4 weeks.

Primary Outcome Measure

Heart rate: nighttime, daytime and 24-h [ Time Frame: Baseline to Week 4 ]

Central Contacts

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