To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study

NCT02299388 | Completed Phase 4 Results DMC

• 1 other identifier: 523963-1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are conducting this research to study the effect of Liraglutide on blood pressure. Several studies have shown increased cardiovascular complications and deaths in diabetics with hypertension. The importance of blood pressure control in diabetes has been shown in many clinical trials. No drug already approved for treating Type 2 Diabetes Mellitus is known to reduce blood pressure along with improving diabetes. However, prior research studies with liraglutide have suggested that treatment with liraglutide improves blood pressure. This effect is seen very quickly and even prior to any weight loss. The mechanism behind this effect is yet to be determined.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent; Hypertensive Disease

Keywords

Type 2 Diabetes Mellitus; Hypertension; ambulatory blood pressure monitoring; Endothelial Dysfunction; Pulse pressure; Renin-angiotensin system; heart rate variability

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.

  To determine whether Liraglutide lowers systolic BP through the day compared to placebo in patients with T2DM who are not on any anti-hypertensive medications or whose BP medications are unchanged over the study period of 8 weeks.

  Baseline and 8 Weeks

Secondary Outcomes (1)

• Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.

  Baseline and 8 Weeks

Other Outcomes (5)

• Change in Endothelial Function. (Using Endo PAT)

  Baseline and 8 Weeks

• Change in Autonomic Function (Heart Rate Variability Using Endo PAT.)

  Baseline and 8 Weeks

• Change in Renin-Angiotensin System (Plasma Renin and Aldosterone Levels and Urine Angiotensinogen Levels)

  Baseline and 8 Weeks

Study Arms (2)

Liraglutide

ACTIVE COMPARATOR

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Drug: Liraglutide or Placebo

Placebo

PLACEBO COMPARATOR

All subjects will be advised a low sodium diet. This will be a placebo controlled, double blind and randomized trial of effects of Liraglutide on systolic BP control. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval. Each subject will be asked to keep a log of activities throughout the day.

Drug: Liraglutide or Placebo

Interventions

Liraglutide or Placebo DRUG

All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.

Also known as: Victoza

Liraglutide; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes, as an adjunct to diet and exercise to improve glycemic control (as per approved label.
• HbA1c\>7% and ≤10.5% at randomization.
• Men and women of 18-75 years of age.
• Women of childbearing potential must agree to use contraception or must not otherwise be at risk of becoming pregnant. A urine pregnancy test will be done at the time of screening and then every 4 weeks for the duration of 8 weeks. If positive, this will be confirmed with a serum pregnancy test which if positive, appropriate action will be taken as outlined in the detailed protocol.
• Blood pressure≥ 130/80 mm Hg and ≤160/100mmHg on stable treatment (no change in anti hypertensive treatment for 3 months prior to screening) or no treatment. No change in treatment for BP over 8 weeks of the study will be allowed.
• Patient understands the study procedures, alternative treatments are available, and the risks involved with the study, and voluntarily agree to participate by providing written informed consent.

You may not qualify if:

• \. Type 1 diabetes and/or history of ketoacidosis determined by medical history.
• \. History of severe diabetic or autonomic neuropathy, gastroparesis or limb ulceration or amputation.
• \. Therapy with DPP-4 inhibitor, or GLP -1 analog or receptor agonist in the past 6 months.
• \. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
• \. Patients on corticosteroids within 3 months or recurrent continuous corticosteroid treatment (\>2 weeks).
• \. Use of weight loss drugs within 3 months of screening or weight loss of ≥10 % in the last 6 months.
• \. Surgery in the past 30 days prior to screening and/or any serious or chronic illness within 6 months or anticipated surgery during the trial period.
• \. Serum creatinine \>1.4mg/dL (women)/\>1.5mg/dL (men). 9. Serum Triglyceride Level \>500 mg/dL. 10. History of pancreatitis. 11. History of drug or alcohol abuse. 12. Poor mental function or any reason to expect patient difficulty in complying with study requirements.
• \. Contraindications to Liraglutide: Personal or family history of medullary thyroid cancer or MEN-2 syndrome 14. Known or suspected allergy to Liraglutide. 15. Diagnosed Secondary hypertension.

Sponsors & Collaborators

• Tulane University School of Medicine: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Tulane University Health Science Center, Tidewater building and Tulane Hospital and Clinics

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Tina Thethi
• Organization: Tulane University

tthethi@tulane.edu

504-988-5044

Study Officials

• Tina Thethi, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: November 24, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 27, 2021
• Results First Posted: May 8, 2019

Record last verified: 2021-01

Locations

US (1)