Diabetes Mellitus, Type 2Phase 4NCT03444142
Effect of Exenatide LAR or Dulaglutide on the Variability of 24-hour Heart Rate and Blood Pressure in Type 2 Diabetes
A Phase 4 study testing Exenatide LAR and Dulaglutide in people with Diabetes Mellitus, Type 2, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 31 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exenatide LAR and Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 17 Nov 2017to 30 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto de terapeutica Experimental y Clinica. Centro universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340
About this study
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.
Read the 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
- Being tested
- Exenatide LAR, Dulaglutide
- Keywords
- Diabetes, Hyperglycemia, ABPM, Variability of blood pressure, Exenatide LAR or Dulaglutide 0.75mg, Glucagon-like peptide analogues type 1 (GLP1).
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide LARDrug
Also called Bydureon
2 mg, once weekly subcutaneously before breakfast during 4 weeks.
DulaglutideDrug
Also called Trulicity
.75 mg once weekly subcutaneously before breakfast during 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Exenatide LAR | Active comparator | Exenatide LAR 2 mg, once weekly subcutaneously before breakfast during 4 weeks. Receives: Drug: Exenatide LAR |
| Drug: Dulaglutide | Active comparator | Dulaglutide .75 mg, once weekly subcutaneously Before breakfast during 4 weeks. Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to Week 4
Secondary outcomes (16)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Week 4
Alanine aminotransferase (ALT) levels
ALT levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques
Measured: 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
Measured: Baseline to Week 4
Creatinine levels
Creatinine levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques
Measured: Baseline to Week 4
Uric acid levels
Uric acid levels will be evaluated at baseline and week 4 with enzymatic/colorimetric techniques
Measured: Baseline to Week 4
Waist Circumference
Waist circumference will be evaluated at baseline and at week 4 with a flexible tape
Measured: Baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start17 Nov 2017
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel González Ortiz, University of Guadalajara
- Investigators
- MANUEL GONZALEZ, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444142
- Sponsor's protocol ID
- Exenatida LAR Dulaglutida-with
- Status last verified
- Mar 2020
- First submitted
- 13 Feb 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03444142
- Acronym / sponsor ID
- Exenatida LAR Dulaglutida-with
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Hyperglycemia, ABPM, Variability of blood pressure, Exenatide LAR or Dulaglutide 0.75mg, Glucagon-like peptide analogues type 1 (GLP1).
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Exenatide LAR | Active comparator | Drug: Exenatide LARExenatide LAR 2 mg, once weekly subcutaneously before breakfast during 4 weeks. |
| Drug: Dulaglutide | Active comparator | Drug: DulaglutideDulaglutide .75 mg, once weekly subcutaneously Before breakfast during 4 weeks. |
Who may qualify
- Ages
- 31 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide LARAlso: Bydureon2 mg, once weekly subcutaneously before breakfast during 4 weeks. | Drug | Drug: Exenatide LAR |
| DulaglutideAlso: Trulicity.75 mg once weekly subcutaneously before breakfast during 4 weeks. | Drug | Drug: Dulaglutide |
Primary outcome
Heart rate: nighttime, daytime and 24-h
Time frame: Baseline to Week 4
heart rate variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3
Systolic blood pressure, daytime, night and 24 h
Time frame: Baseline to Week 4
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O33.
Diastolic blood pressure, daytime, night and 24 h
Time frame: Baseline to Week 4
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3
Blood pressure
Time frame: Baseline to Week 4
Blood pressure will be measured at baseline and week 4 with a digital sphygmomanometer and the entered values reflect the blood pressure.
16 secondary outcomes
Categories: dipper o non dipper
Time frame: Baseline to Week 4
Fasting glucose levels
Time frame: Baseline to Week 4
Central and peripheral blood pressure
Time frame: Baseline to Week 4
Pulse wave velocity
Time frame: Baseline to Week 4
Cardio-ankle Vascular Index (CAVI)
Time frame: Baseline to Week 4
Glycosylated hemoglobin
Time frame: Baseline to Week 4
Body Weight
Time frame: Baseline to Week 4
Body Mass Index
Time frame: Baseline to Week 4
Total cholesterol
Time frame: Baseline to Week 4
Triglycerides levels
Time frame: Baseline to Week 4
High density lipoprotein (c-HDL) levels
Time frame: Baseline to Week 4
Alanine aminotransferase (ALT) levels
Time frame: Baseline to Week 4
Aspartate aminotransferase (AST) levels
Time frame: Baseline to Week 4
Creatinine levels
Time frame: Baseline to Week 4
Uric acid levels
Time frame: Baseline to Week 4
Waist Circumference
Time frame: Baseline, week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MANUEL GONZALEZ, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exenatide LAR and Dulaglutide in people with Diabetes Mellitus, Type 2, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MANUEL GONZALEZ, PhD (+523310585200 ext. 34212, uiec@prodigy.net.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate: nighttime, daytime and 24-h (time frame: Baseline to Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.