Sponsor study identifier
interventional
44
1 country
1
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
February 2, 2018
Actual (reported)February 8, 2018
Actual (reported)April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Sudomotor Function
Changes in peripheral autonomic function using sudorimetry (Sudoscan) after 1 year of treatment.
One Year
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
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
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
Strelitz Diabetes Center
Norfolk, Virginia, 23510, United States
Aaron Vinik, MD, PhD
Eastern Virginia Medical School
First Submitted
February 2, 2018
First Posted
February 8, 2018
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
Contact the study team to confirm eligibility.
April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 11, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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