The Effects of Liraglutide on Sudomotor Function and Inflammation in Type 2 Diabetes
1 other identifier
interventional
44
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 2, 2018
CompletedFirst Posted
Study publicly available on registry
February 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedFebruary 11, 2019
February 1, 2019
3.9 years
February 2, 2018
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Sudomotor Function
Changes in peripheral autonomic function using sudorimetry (Sudoscan) after 1 year of treatment.
One Year
Secondary Outcomes (4)
Inflammatory Markers C-Reactive Protein (CRP)
One year
Inflammatory Markers IL-1β
One Year
Inflammatory Markers IL6
One Year
Inflammatory Markers Tumor Necrosis factor α (TNF α)
One Year
Study Arms (2)
Placebo
PLACEBO COMPARATORSame 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
Liraglutide 6 mg Solution for Injection
EXPERIMENTALAfter 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
Interventions
Eligibility Criteria
You may qualify if:
- established type 2 diabetes (diabetes duration of \>6 months and \<10 years).
- Age 18-80 years
- HbA1c at screening ≤ 10%
- Subjects on stable (≥3 months prior to Screening) Standard of Care background diabetic therapy. Diabetic treatment regimens include diet and exercise alone or in association with oral anti-diabetic drugs (monotherapy or combinations) and/or long-acting insulin.
You may not qualify if:
- Presence of type 1 diabetes mellitus (defined as C-peptide \<1 ng /ml, \<35y and prone to ketoacidosis)
- Treatment with rapid-acting or short-acting insulin within the last 3 months
- Proliferative retinopathy or maculopathy requiring acute treatment
- Impaired renal function , defined as serum creatinine ≥ 125 µmol/L (≥1.4 mg/dL) for males and ≥ 110 µmol/L (≥1.24 mg/dL) for females
- Impaired liver function, defined as aspartate transaminase (AST) or alanine transaminase (ALT), ≥ 2.5 times the upper limit of normal
- Presence of clinically significant peripheral or autonomic neuropathy that is clearly of non-diabetic origin
- Uncontrolled treated/untreated hypertension (systolic blood pressure (BP) ≥180 or diastolic blood pressure (BP) ≥100 at screening)
- Subjects known to be Hepatitis B surface antigen or Hepatitis C antibody positive with active hepatitis.
- Active infection (e.g., human immunodeficiency virus (HIV), hepatitis), or a history of severe infection during the 30 days prior to screening
- Evidence of immunocompromised status, including but not limited to individuals who have undergone organ transplantation, who are known to be HIV positive, or who are taking immunosuppressive drugs or chronic systemic corticosteroid treatment.
- Major surgical procedure during the 30 days prior to screening
- Diagnosis and/or treatment of malignancy (except for basal cell or squamous cell skin cancer, in-situ carcinoma of the cervix, or in-situ prostate cancer) within the past 5 years
- Known clinically significant gastric emptying abnormality (e.g. severe gastroparesis), or history of gastric bypass (bariatric) surgery
- Thyroid stimulating hormone (TSH) outside of normal limits at screening, or presence of a thyroid nodule detected on physical examination that has not been fully evaluated
- Thyroid hormone therapy that has not been stable for ≥6 weeks prior to Screening
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Strelitz Diabetes Center
Norfolk, Virginia, 23510, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron Vinik, MD, PhD
Eastern Virginia Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine/Pathology/Neurobiology Director of Research & Neuroendocrine Unit
Study Record Dates
First Submitted
February 2, 2018
First Posted
February 8, 2018
Study Start
May 1, 2016
Primary Completion
April 1, 2020
Study Completion
August 1, 2020
Last Updated
February 11, 2019
Record last verified: 2019-02