Semaglutide for Type 2 Diabetes and Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Andrea Hansis-Diarte, MPh

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Marzieh Salehi

Must be taking: Metformin

Must not be taking: Steroids, Glucose altering, others

Disqualifiers: Chronic neurological illness, Renal impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether semaglutide, a diabetes medication, can effectively help people with both type 2 diabetes and a spinal cord injury (SCI) control their blood sugar levels. Participants will receive either semaglutide or a placebo (a substance with no active medicine) to compare the effects. The trial aims to determine if semaglutide can improve diabetes management for those with SCI, a group at higher risk for diabetes. Individuals who have had a spinal cord injury for more than a year and are managing type 2 diabetes with diet and metformin might be suitable candidates. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that participants manage their glucose levels with diet and metformin only, without significant dose changes in the three months prior to screening. If you are taking other glucose-altering medications, steroids, or certain weight control drugs, you may need to stop them before joining the study.

What is the safety track record for semaglutide?

Research has shown that semaglutide, a drug for diabetes, is generally well-tolerated. In past studies, participants who took semaglutide once a week for 26 weeks experienced improvements in body composition and blood sugar levels. This suggests that most people can handle the treatment well.

However, some considerations are necessary. One report found that semaglutide might increase the likelihood of needing additional surgeries after certain back procedures. This is important to consider if related health issues are present.

Overall, semaglutide is widely used and has received FDA approval for treating type 2 diabetes, indicating its safety for intended uses. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Semaglutide is unique because it not only targets type 2 diabetes but also holds promise for individuals with spinal cord injuries. Unlike standard diabetes treatments that primarily focus on insulin regulation, semaglutide is a GLP-1 receptor agonist, which means it mimics a natural hormone that increases insulin secretion and reduces appetite. This dual action can be particularly beneficial for managing blood sugar levels and weight, both of which are crucial for type 2 diabetes management. Researchers are excited about semaglutide because its once-weekly injection offers convenience and improved adherence compared to daily medications, and its potential effects on nerve health could provide additional benefits for those with spinal cord injuries.

What evidence suggests that semaglutide might be an effective treatment for type 2 diabetes in individuals with spinal cord injury?

Research shows that semaglutide, which participants in this trial may receive, effectively manages type 2 diabetes by controlling blood sugar levels and supporting weight loss. In earlier studies, patients using semaglutide for 26 weeks experienced improved body composition and better blood sugar control. This medication mimics a hormone in the body that regulates insulin, crucial for maintaining healthy blood sugar levels. While its effectiveness for people with spinal cord injuries remains uncertain, semaglutide is already approved and effective for treating type 2 diabetes in the general population. ^{1 2 3 4 6}

Who Is on the Research Team?

Marzieh Salehi, MD, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with spinal cord injury (C2-L2, Asia Impairment Scale A-D), type 2 diabetes managed with diet/metformin, and a BMI over 22. They must be at least one year post-injury and not on certain medications or have conditions like severe allergies, significant anemia, liver disease, recent heart issues, or history of cancer within the last five years.

Inclusion Criteria

My spinal cord injury is between C2 and L2 and is classified as A, B, C, or D.

HbA1c 6.0-9.0% at screening

Provision of signed and dated written informed consent prior to any study specific procedures

Exclusion Criteria

My kidney function is low, with an eGFR below 45 mL/min.

Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, acetaminophen

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a mixed meal tolerance test and a glucose clamp study to assess baseline glucose response and insulin sensitivity

1-2 weeks

2 visits (in-person)

Treatment

Participants are randomized to receive either semaglutide or placebo for 24 weeks, with regular phone calls and in-person visits for monitoring

24 weeks

7-9 visits (in-person), 9-10 visits (phone)

Follow-up

Participants repeat meal and glucose studies to assess changes in glucose tolerance and insulin sensitivity after treatment

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The study tests semaglutide's effectiveness in controlling blood sugar levels in those with spinal cord injuries who also have type 2 diabetes. Participants will either receive semaglutide injections or a placebo to compare outcomes related to glucose control and weight loss.

How Is the Trial Designed?

Group I: SCI and T2DM Treatment Group Experimental Treatment 1 Intervention

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.

Group II: SCI and T2DM Placebo Group Placebo Group 1 Intervention

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.

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Marzieh Salehi

Lead Sponsor

Trials

1

Recruited

50+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

Semaglutide, a long-acting GLP-1 receptor agonist, has been shown to significantly reduce HbA1c, fasting plasma glucose, body weight, and blood pressure in over 9,000 patients with type 2 diabetes, demonstrating greater efficacy than other GLP-1RAs.

While semaglutide has a low risk of hypoglycemia, it is associated with gastrointestinal side effects, and there is a warning regarding an increased risk of diabetes-related retinopathy in patients with preexisting conditions, necessitating further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical potential of treatment with semaglutide in type 2 diabetes patients. Røder, ME.[2020]

In a post hoc analysis of 5,119 subjects from the SUSTAIN clinical trials, semaglutide (0.5 and 1.0 mg) led to significantly higher rates of achieving both ≥1.0% HbA1c reduction and ≥5.0% weight loss compared to other diabetes treatments, with rates ranging from 25% to 59% for semaglutide versus 2% to 23% for comparators.

Semaglutide was well tolerated and exhibited a safety profile similar to other GLP-1 receptor agonists, indicating it is a safe and effective option for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GREATER COMBINED REDUCTIONS IN HbA1C ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Rodbard, HW., Bellary, S., Hramiak, I., et al.[2022]

Semaglutide, a GLP-1 receptor agonist with a long half-life, effectively promotes insulin secretion in a glucose-dependent manner, making it a valuable treatment for type 2 diabetes, approved for use worldwide and in Japan since 2018.

Oral semaglutide (Rybelsus®) is the first GLP-1 receptor agonist available in pill form, showing continuous benefits in glycemic control for patients with type 2 diabetes across various stages, as demonstrated in multiple global clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist]. Miyasaka, K.[2022]

In a study involving 452 patients with type 2 diabetes, once-weekly semaglutide significantly reduced HbA1c levels by an average of 0.9 percentage points and body weight by 4.3 kg over approximately 30 weeks.

Nearly half of the patients (46.9%) achieved an HbA1c of less than 7.0%, and no new safety concerns were reported, indicating that semaglutide is both effective and safe for use in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of once-weekly semaglutide in patients with type 2 diabetes in routine clinical practice: Results from the SURE Canada multicentre, prospective, observational study. Yale, JF., Catarig, AM., Grau, K., et al.[2022]

In a phase 3a trial involving 1089 participants, semaglutide significantly reduced HbA1c levels more than insulin glargine, achieving reductions of 1.21% and 1.64% for 0.5 mg and 1.0 mg doses, respectively, compared to 0.83% with insulin glargine.

Semaglutide also led to weight loss (3.47 kg and 5.17 kg for the two doses) while insulin glargine resulted in weight gain (1.15 kg), and semaglutide was associated with fewer hypoglycaemic episodes, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Aroda, VR., Bain, SC., Cariou, B., et al.[2022]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

In a study of 5 individuals with spinal cord injury, those treated with semaglutide for 26 weeks experienced significant reductions in body weight, fat mass, and visceral fat, indicating improved body composition.

Participants receiving semaglutide also showed improvements in glycemic control, with decreases in fasting plasma glucose and HbA1c levels, suggesting a lower risk of cardiometabolic diseases compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary observations on the administration of a glucagon-like peptide-1 receptor agonist on body weight and select carbohydrate endpoints in persons with spinal cord injury: A controlled case series. Cirnigliaro, CM., La Fountaine, MF., Sauer, SJ., et al.[2023]

In a trial involving 302 patients with inadequately controlled type 2 diabetes, adding semaglutide to SGLT-2 inhibitor therapy resulted in significant reductions in HbA1c levels (-1.42%) and body weight (-3.81 kg) compared to placebo, indicating improved glycemic control and weight management.

Semaglutide was generally well tolerated, although gastrointestinal adverse events were more common in the semaglutide group (37.3%) compared to placebo (13.2%), with a low incidence of serious adverse events and no reported deaths during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. Zinman, B., Bhosekar, V., Busch, R., et al.[2020]

Oral semaglutide significantly reduced HbA1c levels by 1.0 to 1.5% and body weight by 2.2 to 5.0 kg in patients with type 2 diabetes, regardless of their background medications, indicating its broad efficacy across different treatment regimens.

The safety profile of oral semaglutide was consistent across various background medication subgroups, with no significant increase in adverse events, making it a suitable option for patients using other glucose-lowering agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Pratley, RE., Crowley, MJ., Gislum, M., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03292315

Once Weekly GLP-1 in Persons With Spinal Cord Injury Chronic spinal cord injury (SCI) results in adverse soft tissue body composition changes and an extremely sedentary lifestyle. These abrupt changes often ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218576/

Preliminary observations on the administration of a glucagon ... Administration of semaglutide for 26 weeks resulted in favorable changes in body composition and glycemic control, suggesting a reduced risk for the development ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06706284/glycemic-and-weight-loss-effects-of-glp-1r-agonist-therapy-in-subjects-with-spinal-cord-injury-and-type-2-diabetes

Glycemic and Weight Loss Effects of GLP-1R Agonist ... 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)

4. withpower.com withpower.com/trial/phase-4-weight-loss-2025-e5ad5

Semaglutide for Type 2 Diabetes and Spinal Cord Injury Trial Overview The study tests semaglutide's effectiveness in controlling blood sugar levels in those with spinal cord injuries who also have type 2 diabetes.

5. reporter.nih.gov reporter.nih.gov/project-details/11179324

Project Details Our preliminary data demonstrate that patients with SCI are treated with GLP-1RA at a 10-times lower rate than AB population. The cause for this health ...

6. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/42/1/article-p1.xml

Semaglutide exposure and its association with adverse ... Semaglutide exposure appears to be associated with a higher likelihood of additional lumbar fusion surgeries within 1 year post-TLIF.