Status:
COMPLETED
To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
Lead Sponsor:
Tulane University School of Medicine
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Non-Insulin-Dependent
Hypertensive Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 hype...
Detailed Description
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 hype...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Type 1 diabetes and/or history of ketoacidosis determined by medical history.
- 2\. History of severe diabetic or autonomic neuropathy, gastroparesis or limb ulceration or amputation.
- 3\. Therapy with DPP-4 inhibitor, or GLP -1 analog or receptor agonist in the past 6 months.
- 4\. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
- 5\. Patients on corticosteroids within 3 months or recurrent continuous corticosteroid treatment (\>2 weeks).
- 6\. Use of weight loss drugs within 3 months of screening or weight loss of ≥10 % in the last 6 months.
- 7\. 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.
- 8\. 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.
- 13\. 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02299388
Start Date
October 1 2014
End Date
December 1 2016
Last Update
January 27 2021
Active Locations (1)
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1
Tulane University Health Science Center, Tidewater building and Tulane Hospital and Clinics
New Orleans, Louisiana, United States, 70112