CompletedPhase 4

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

United States11 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and 8 Weeks

Trial details

NCT IDNCT02299388

SponsorTulane University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11

Results submitted2018-04-26

View on ClinicalTrials.gov More Diabetes Mellitus, Non-Insulin-Dependent trials