Primary outcomeMean· Baseline and 8 Weeks
Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.
| Group | Value (mm/Hg) |
|---|---|
| Liraglutide | -4.88 |
| Placebo | -5.45 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataTo Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
NCTNCT02299388 (opens ClinicalTrials.gov in a new tab)Other id523963-1
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 11 participants (actual)
- Sponsor
- Tulane University School of Medicine · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Oct 2014
- Primary completion
- Nov 2016
- Completion
- Dec 2016
- First posted
- 24 Nov 2014 (estimated)
- Last update posted
- 27 Jan 2021
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent · Hypertensive Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2014201520162017
- Ph 4
To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
NCT02299388Oct 2014 to Dec 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Liraglutide or PlaceboDrug
Arms2
Active comparator
Liraglutide
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.
Placebo comparator
Placebo
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.
Time frame · Baseline and 8 Weeks
Registry description
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.
Secondary outcomes(1)
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
Time frame · Baseline and 8 Weeks
Registry description
1. Change in mean arterial blood pressure and diastolic blood pressure from baseline to 8 weeks in the intent-to-treat (ITT) population. 2. Change in nocturnal BP: the absence of the nocturnal (between 23:00-06:00 hrs) decline in BP of \>/= 10% (defined as "non-dippers") and whether restoration occurs following Liraglutide therapy. 3. Change in pulse pressure: defined as the difference in systolic and diastolic BPs from baseline to week 8.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline and 8 Weeks
Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.
| Group | Value (mm/Hg) |
|---|---|
| Liraglutide | -4.4 |
| Placebo | -5.4 |
Other pre specified outcome· Baseline and 8 Weeks
Change in Endothelial Function. (Using Endo PAT)
| Group | Value |
|---|
Other pre specified outcome· Baseline and 8 Weeks
Change in Autonomic Function (Heart Rate Variability Using Endo PAT.)
| Group | Value |
|---|
Other pre specified outcome· Baseline and 8 Weeks
Change in Renin-Angiotensin System (Plasma Renin and Aldosterone Levels and Urine Angiotensinogen Levels)
| Group | Value |
|---|
Other pre specified outcome· Baseline and 8 Weeks
Change in Catecholamines (Collecting 24 Hrs Urine for Metanephrines and Catecholamines.)
| Group | Value |
|---|
Other pre specified outcome· Baseline and 8 Weeks
Change in Urinary Sodium Excretion
| Group | Value |
|---|
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LiraglutideAll 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. Liraglutide or Placebo: 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. | 0 / 6 | 0 / 6 | 0 / 6 |
| PlaceboAll 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. Liraglutide or Placebo: 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. | 0 / 5 | 0 / 5 | 0 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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