A Phase 2 interventional study of Liraglutide 6 mg Solution for Injection and Placebo in Autonomic Nervous System Diseases, Sweat Gland Diseases and Diabetic Neuropathy With Neurologic Complication, sponsored by Eastern Virginia Medical School. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Eastern Virginia Medical School · Phase 2, Interventional, and Prevention
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Among 49 studies in Autonomic Nervous System Diseases with a site in United States — 12 open to participants now, 16 under way, none of them phase 3. Autonomic Nervous System Diseases · United States.
Among the 49 studies in Autonomic Nervous System Diseases with a site in United States, this one is the 11th largest by planned enrollment of the 31 interventional ones that give a count, is one of 3 that started in 2016, is one of 3 in phase 2, and was the 24th registered.
108 studies on the registry are indexed under Autonomic Nervous System Diseases; 29 are open to participants now.
Browse Autonomic Nervous System Diseases studies →12 of the 49 studies in Autonomic Nervous System Diseases with a site in United States are open now. Recruiting first, the newest first:
Stephen G. Kaler · Sites in United States
Ages 7–17
VA Office of Research and Development · Sites in United States
Ages 22–88 · Healthy volunteers
Medical College of Wisconsin · Sites in United States
Ages 11–18 · Women only · Healthy volunteers
National Institute of Neurological Disorders and Stroke (NINDS) · Sites in United States
Ages 18–110
University of California, Los Angeles · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Autonomic Nervous System Diseases studies recruiting now, 6 (29%) set no upper age limit and 12 (57%) stop at 75 or younger; 6 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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49 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 9 · Phase 3 2 · Phase 4 1
First in 1994; this study’s year is marked. 3 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 44 is close to the median of 40 across 72 interventional studies indexed under Autonomic Nervous System Diseases.
Median enrollment 20 across the 31 interventional studies, 63 across the 18 observational. Of the 30 that completed or were terminated, 6 (20%) have results posted.
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None of the 49 has an industry lead sponsor. The 10 most frequent:
Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Eastern Virginia Medical School has 1 study filed under Autonomic Nervous System Diseases — fewer than ten, so there is no comparison to draw.
4 of the studies in Autonomic Nervous System Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01988883Vanderbilt University Medical CenterModafinil and Cognitive Function in POTS | 2026-12 |
| NCT05400174University of California, San DiegoBlood Pressure Effects on Cognition and Brain Blood Flow in PD | 2026-12-15 |
| NCT02725060Vanderbilt University Medical CenterAutoimmune Basis for Postural Tachycardia Syndrome | 2027-02 |
| NCT06419959VA Office of Research and DevelopmentNightWare and Cardiovascular Health in Veterans With PTSD | 2027-09-30 |
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Among the 49 studies in Autonomic Nervous System Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to conduct an interventional, one year, randomized, double blind, placebo-controlled trial with Liraglutide in patients with type 2 diabetes (diabetes duration of >6 months and \<10 years, HbA1c \<10%) to evaluate its effects on the peripheral autonomic nervous system, as well as inflammatory markers, and measures of oxidative and nitrosative stress.
The investigators propose to examine the effects of GLP-1 receptor agonist Liraglutide on autonomic sudomotor function and endothelial and neurovascular functions as well as markers of inflammation in patients with type 2 diabetes mellitus (T2DM). The primary objective will be changes in peripheral autonomic function using sudorimetry (Sudoscan) after 1 year of treatment.
The secondary objectives include changes on markers of inflammation and oxidative/nitrosative stress including C-reactive protein (CRP), interleukin 1 beta (IL-1β), Interleukin 6 (IL6), interleukin 12 (IL12), interleukin 10 (IL10), tumor necrosis factor α (TNF α), plasminogen activator Inhibitor 1 (PAI-1), superoxide dismutase (SOD), nitrotyrosine, carboxymethyl-lysine (CML), thiobarbituric acid reactive substances (TBARS), and asymmetric dimethylarginine (ADMA). Additional objectives include changes in neurovascular and endothelial function, measured by continuous Laser Doppler assessment of skin blood flow in response to different stimuli; and changes in sensory-motor peripheral nerve function, measured by clinical neuropathy scores (NSS \& NIS), quantitative sensory testing and nerve conduction testing.
The aim of this study is to capture patients early in the disease process, when autonomic dysfunction is still potentially reversible. Several studies have shown the presence of autonomic imbalance in the early stages of diabetes and even in the pre-diabetic state (impaired glucose tolerance, impaired fasting glucose, and metabolic syndrome). We hypothesize that by treating type 2 diabetic patients with Liraglutide early in the disease process (\<10 years of diagnosis), we will be able to improve peripheral autonomic imbalance, endothelial and neurovascular function, and reduce inflammation and oxidative/nitrosative stress. This will shed further insight into the mechanisms by which glucagon-like peptide-1 (GLP-1) exerts a neuroprotective role and improves the inflammatory process. The possibility of improving autonomic imbalance, endothelial function and inflammation may have important impact in the development of new potential therapeutic strategies to abrogate the microvascular complications of diabetes
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Same formulation as active medication minus the active ingredient. Patients will start with 0.1 mL of liraglutide placebo and will escalate the dose every week in 0.1 ml increments until the 0.3 ml dose is reached. Escalation will be done according to patients' tolerance and glucose control
Other: Placebo
After randomization, patients will undergo a treatment dose escalation phase. Liraglutide will be started at 0.6 mg SQ QD for 1 week, increased to 1.2 mg subcutaneous, per day (SQ, QD) for 1 week, and then increased and maintained on 1.8 mg SQ QD or maximally tolerated dose if self monitored blood glucose (SMBG) is at goal. Escalation will be done according to patients' tolerance and glucose control
Drug: Liraglutide 6 mg Solution for Injection
Sudomotor Function
Changes in peripheral autonomic function using sudorimetry (Sudoscan) after 1 year of treatment.
Time frame: One Year
Inflammatory Markers C-Reactive Protein (CRP)
Changes on markers of inflammation and oxidative/nitrosative stress including C-reactive protein (CRP)
Time frame: One year
Inflammatory Markers IL-1β
Changes on markers of inflammation and oxidative/nitrosative stress including IL-1β
Time frame: One Year
Inflammatory Markers IL6
Changes on markers of inflammation and oxidative/nitrosative stress including IL6
Time frame: One Year
Inflammatory Markers Tumor Necrosis factor α (TNF α)
Changes on markers of inflammation and oxidative/nitrosative stress including Tumor Necrosis factor α (TNF α)
Time frame: One Year
The record gives a start of May 2016, a primary completion of Apr 2020 and a completion of Aug 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liraglutide
Autonomic Nervous System Diseases →
Eastern Virginia Medical School