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Glucagon-like peptide-1 (GLP-1) receptor agonist

Liraglutide 6 mg Solution for Injection for Autonomic Nervous System Disorders

Phase 2
Waitlist Available
Led By Aaron Vinik, MD, PhD
Research Sponsored by Eastern Virginia Medical School
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Summary

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.

Eligible Conditions
  • Autonomic Nervous System Disorders
  • Hyperhidrosis
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sudomotor Function
Secondary study objectives
Inflammatory Markers C-Reactive Protein (CRP)
Inflammatory Markers IL-1β
Inflammatory Markers IL6
+1 more

Side effects data

From 2014 Phase 4 trial • 368 Patients • NCT02008682
15%
Nausea
11%
Decreased appetite
8%
Diarrhoea
6%
Lipase increased
1%
Diabetic ketoacidosis
1%
Sudden hearing loss
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liraglutide
Sitagliptin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Liraglutide 6 mg Solution for InjectionExperimental Treatment1 Intervention
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
Group II: PlaceboPlacebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

Eastern Virginia Medical SchoolLead Sponsor
72 Previous Clinical Trials
15,675 Total Patients Enrolled
Aaron Vinik, MD, PhDPrincipal InvestigatorEastern Virginia Medical School
~5 spots leftby Sep 2025
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