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Glucagon-like peptide-1 (GLP-1) receptor agonist
The Effects of Liraglutide on Sudomotor Function and Inflammation in Type 2 Diabetes
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
All Individual Drugs Already Approved
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 Dysfunction
- Hyperhidrosis
- Diabetic Neuropathy
- Autonomic Nervous System Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
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 moreSide effects data
From 2014 Phase 4 trial • 368 Patients • NCT0200868215%
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
74 Previous Clinical Trials
15,987 Total Patients Enrolled
Aaron Vinik, MD, PhDPrincipal InvestigatorEastern Virginia Medical School