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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tulane University Health Sciences Center; Tulane University School of Medicine
• Collaborator: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.