Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT02235519
• Date of registration: 05/09/2014
• Prospective Registration: No
• Primary sponsor: Hospital General de México Dr. Eduardo Liceaga
• Public title: Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients
• Scientific title: A Randomized, Open Label Study to Evaluate the Pleiotropic Effects of Azilsartan Medoxomil 40 and 80 mg for 12 Weeks Over Metabolic Markers in Patients With Hypertension, Obesity or Type 2 Diabetes Mellitus
• Date of first enrolment: January 2014
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02235519
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Mexico

Contacts

• Name: Estrella Martinez, RN
• Affiliation: HGM

• Name: Antonio Peralta, MD

• Name: Antonio Peralta, MD
• Affiliation: HGM

• Name: Juan A Peralta, bachelor

• Name: Rogelio Zapata, MD
• Affiliation: HGM

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent in accordance with Good Clinical Practices and local
legislations

2. Age between =25 and = 65 years

3. Patients with hypertension stage 1 as defined by systolic blood pressure (SBP) =140
but <159 mmHg and diastolic blood pressure (DBP) =90 but < 99 mmHg at randomization

4. Ability to stop any current antihypertensive therapy without unacceptable risk to the
patient (Investigator's discretion)

5. BMI =25 and =35.

6. Patients with type 2 diabetes mellitus can participate and will be stratified before
randomization. Diagnosis can be established by clinical history, 75-g oral glucose
tolerance test (ADA criteria), or fasting glucose > 126 mg/dL.

Exclusion Criteria:

1. Pre-menopausal women (last menstruation =1 year prior to signing informed consent)
who are not surgically sterile, nursing, are pregnant or without any anticonceptive
methods.

2. Known hypersensitivity to the study drug

3. Gastrointestinal surgery which might alter absorption, distribution, or drug
metabolism.

4. History of angioedema related to ACE inhibitors or angiotensin II receptor blockers.

5. Night shift workers who routinely sleep during the daytime and whose work hours
include midnight to 4:00 a.m.

6. Known or suspected secondary hypertension (e.g., renal artery stenosis or
phaeochromocytoma)

7. SBP=160 mmHg and/or DBP =100 mmHg

8. Renal dysfunction as defined by: serum creatinine >3.0 mg/dL (or >265 umol/L) and/or
creatinine clearance <30 ml/min and/or other clinical markers of severe renal
impairment.

9. Bilateral renal arterial stenosis, renal artery stenosis in a solitary functional
kidney, post-renal transplant patients or patients with one kidney

10. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L,
may be rechecked for suspected error in result)

11. Uncorrected sodium or volume depletion

12. Primary aldosteronism.

13. Hereditary fructose intolerance

14. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency

15. Congestive heart failure class III-IV according to criteria fron the New York Heart
Association.

16. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter
or other clinically relevant cardiac arrhythmias as determined by the Investigator.

17. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease,
aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

18. Patients whose diabetes has not been stable and controlled for at least the past 3
months as defined by an Glycosylated Hemoglobin A1c >=10% or fasting glucose greater
than 400 mg/dL.

19. Patients who have previously experienced symptoms characteristic of angioedema during
treatment with ACE inhibitors or angiotensin-II receptor antagonists

20. History of drug or alcohol dependency within 6 months prior to signing the informed
consent form

21. Concomitant administration of any medications known to affect blood pressure, except
medications allowed by the protocol

22. Any investigational drug therapy within 1 month of signing the informed consent

23. Known hypersensitivity to any component of the trial drugs (telmisartan,
hydrochlorothiazide, or placebo)

24. History of non-compliance or inability to comply with prescribed medications or
protocol procedures (less than 80% or more than 120%, especially during run-in).

25. Any other clinical condition which, in the opinion of the investigator, would not
allow safe completion of the protocol and safe administration of the trial medication



Age minimum: 25 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Obesity

Hypertension

Intervention(s)

Drug: Azilsartan 80 mg

Drug: Azilsartan 40 mg.

Primary Outcome(s)

Blood pressure [Time Frame: 12 weeks]

Secondary Outcome(s)

Insulin sensitivity and HbA1c level [Time Frame: 12 weeks]

Endothelial function [Time Frame: 12 weeks]

Effect of azilsartan on Inflammatory markers [Time Frame: 12 weeks]

Renal function improvement. [Time Frame: 12 weeks]

Secondary ID(s)

DI/12/404B/4/85

Source(s) of Monetary Support

Please refer to primary and secondary sponsors