Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMarzieh Salehi
About this trial
It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subjects aged 18-70 years (inclusive) at screening
More than one year after spinal cord injury
Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D.
Provision of signed and dated written informed consent prior to any study specific procedures
Disqualifiers
History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures.
Any subject who has received another investigational product as part of a clinical study within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening
Taking mirabegron or other glucose altering medications
Taking steroids within the past 1 year
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide Injectable Product
DrugA GLP-1 inhibitor used to control T2DM
Placebo
Other interventionSaline solution will be administered with the same frequency as semaglutide and participants will be instructed how to use the saline in the same manner as the active drug group.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SCI and T2DM Treatment GroupExperimental treatment 1 intervention
Group B: SCI and T2DM Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Glucose tolerance
The change in the incremental AUC Glucose3h response to meal ingestion
Time frame
Baseline to 24 weeks2
Insulin action
Liver, adipose tissue and muscle insulin sensitivity determined using a two-step euglycemic clamp.
Time frame
Baseline to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marzieh Salehi
Lead sponsor
The University of Texas Health Science Center at San Antonio
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov