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UnknownPhase 4

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

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.

Assets

Dulaglutide / Exenatide

Listed sites

1

Recruiting sites

1

Enrollment

30

estimated

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

Heart rate, changeSystolic BP, changeDiastolic BP, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03444142
Org study IDExenatida LAR Dulaglutida-with

Timeline

Milestones

Study start2017-11-17actual
Study first posted2018-02-23actual
Last update posted2020-03-26actual
Primary completion2021-11-30estimated
Study completion2021-11-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age31 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
11
Weight & body composition
3
Glycemic / diabetes
2
MASH / liver
2
Renal / kidney
1
Other (unclassified)
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Body Weight

Time frame:Baseline to Week 4

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body Mass Index

Time frame:Baseline to Week 4

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist Circumference

Time frame:Baseline, week 4

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Fasting glucose levels

Time frame:Baseline to Week 4

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Glycosylated hemoglobin

Time frame:Baseline to Week 4

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints
Secondary/protocol endpoint

Alanine aminotransferase (ALT) levels

Time frame:Baseline to Week 4

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Aspartate aminotransferase (AST) levels

Time frame:Baseline to Week 4

AST, change

change from baseline, improvement

LOINC 1920-8

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Creatinine levels

Time frame:Baseline to Week 4

change from baseline, improvement

Cardiometabolic biomarkers

11 endpoints
Primary/protocol endpoint

Heart rate: nighttime, daytime and 24-h

Time frame:Baseline to Week 4

Heart rate, change

change from baseline, improvement

Primary/protocol endpoint

Systolic blood pressure, daytime, night and 24 h

Time frame:Baseline to Week 4

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Primary/protocol endpoint

Diastolic blood pressure, daytime, night and 24 h

Time frame:Baseline to Week 4

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Primary/protocol endpoint

Blood pressure

Time frame:Baseline to Week 4

change from baseline, improvement

Secondary/protocol endpoint

Categories: dipper o non dipper

Time frame:Baseline to Week 4

categorical status, improvement

Secondary/protocol endpoint

Central and peripheral blood pressure

Time frame:Baseline to Week 4

change from baseline, improvement

Secondary/protocol endpoint

Pulse wave velocity

Time frame:Baseline to Week 4

change from baseline, improvement

Secondary/protocol endpoint

Cardio-ankle Vascular Index (CAVI)

Time frame:Baseline to Week 4

change from baseline, improvement

Secondary/protocol endpoint

Total cholesterol

Time frame:Baseline to Week 4

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Triglycerides levels

Time frame:Baseline to Week 4

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

High density lipoprotein (c-HDL) levels

Time frame:Baseline to Week 4

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Uric acid levels

Time frame:Baseline to Week 4

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.