The Effects of Liraglutide on Sudomotor Function and Inflammation in Type 2 Diabetes

Conditions

• Autonomic Nervous System Diseases
• Diabetic Neuropathy With Neurologic Complication
• Sweat Gland Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Liraglutide 6 mg Solution for Injection — DRUG
• Placebo — OTHER

Study Details

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.

Key Dates

Start date

May 31, 2016

Status verified

Feb 2019

Primary completion

Apr 30, 2020

Completion

Aug 31, 2020

Study Design

Enrollment

44 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: Placebo
  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
• Experimental: Liraglutide 6 mg Solution for Injection
  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

Primary Outcome Measure

Sudomotor Function [ Time Frame: One Year ]

Central Contacts

• Henri K Parson, PhD
  7574467976
  [email protected]
• Joshua F Edwards, MPH
  7574460335
  [email protected]

Locations (1)

Find similar trials in Norfolk, VA

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