Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes

NCT06706284 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: STUDY00000591R01DK140144-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Spinal Cord Injuries; Type 2 Diabetes

Keywords

Glucose regulation; Semaglutide; Ozempic; Glucagon- Like Peptide 1 (GLP-1)

Outcome Measures

Primary Outcomes (2)

• Glucose tolerance

  The change in the incremental AUC Glucose3h response to meal ingestion

  Baseline to 24 weeks

• Insulin action

  Liver, adipose tissue and muscle insulin sensitivity determined using a two-step euglycemic clamp.

  Baseline to 24 weeks

Study Arms (2)

SCI and T2DM Treatment Group

EXPERIMENTAL

Participants with spinal cord injury (SCI) and type 2 diabetes (T2DM) will be assigned to semaglutide weekly for 24 weeks. Semaglutide administration: once-weekly self-administration of SGT, titrated to a dose of 2 mg/week as per FDA approved guidelines. All subjects will be instructed how to inject and titrate up the dose.

Drug: Semaglutide Injectable Product

SCI and T2DM Placebo Group

PLACEBO COMPARATOR

Participants with spinal cord injury (SCI) and type 2 diabetes (T2DM) will be assigned to the placebo group and inject normal saline weekly for 24 weeks. All subjects in the placebo group will be instructed how to inject and titrate up the dose to mimic the semaglutide administration to a maximum dose of 2 mg in 12 weeks and then continue for remainder of study.

Other: Placebo

Interventions

Semaglutide Injectable Product DRUG

A GLP-1 inhibitor used to control T2DM

Also known as: Ozempic

SCI and T2DM Treatment Group

Placebo OTHER

Saline 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.

Also known as: Saline solution

SCI and T2DM Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Diagnosed with T2DM with glucose control managed with diet and metformin monotherapy where no significant dose changes (increase or decrease ≥ 50%) have occurred in the three months prior to screening
• HbA1c 6.0-9.0% at screening
• BMI \> 22 kg/m2 at screening
• Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization, and must not be lactating
• Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

You may not qualify if:

• 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
• Significant anemia (hemoglobin\<11g/dL)
• History of gastric outlet obstruction or chronic diarrhea
• History of a chronic neurological illness other than SCI (i.e.; MS, etc)
• Any subject who has received any of the following medications within the specified time-frame prior to the start of the study
• Herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within a year prior to the start of the study
• Pioglitazone, SGLT2 or DPPIV inhibitors, GLP-1RA within the last 60 days at the time of screening
• Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, acetaminophen
• Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening.
• Acute or chronic pancreatitis
• Significant hepatic disease (except for metabolic dysfunction-associated steatohepatitis \[MASH\] or metabolic dysfunction-associated steatotic liver disease \[MASLD\]) without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
• Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN) Alanine transaminase (ALT) ≥ 3 × ULN Total bilirubin ≥ 2 × ULN

Sponsors & Collaborators

• Marzieh Salehi: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University Health - Texas Diabetic Institute

San Antonio, Texas, 78207, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Diabetes Mellitus, Type 2

Interventions

semaglutide; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Marzieh Salehi, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marzieh Salehi, MD

CONTACT

210-567-6691; salehi@uthscsa.edu

Andrea Hansis-Diarte, MPh

CONTACT

210 567 3208; hansisdiarte@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to the treatment assignment. The study team will be unblinded. The investigators will deliver the treatment assignments to the hospital pharmacist as they occur.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Division of Diabetes/ Medicine, University of Texas Health Science Center at San Antonio

Model Details: Controlled 2 arm assignment study. The investigators will stochastically match the patient characteristics between the two arms using for a 2:1 design in terms of level of gender (male, female), level of injury (tetraplegia, paraplegia), dichotomized baseline HbA1c (above or below 7.5%), dichotomized age (above or below a median age for this population) and dichotomized BMI (above or below a median BMI for this population)

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: April 11, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study data will be shared as summary results on ClinicalTrials.gov a year after the primary completion date and full results will be shared at study end after data has been analyzed and published in a peer review journal.
• Access Criteria: The scientific data generated from this study will be shared in the Texas Digital Library

Locations

US (2)