Semaglutide for Type 2 Diabetes and Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Marzieh Salehi, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

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

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the drug Semaglutide for Type 2 Diabetes and Spinal Cord Injury?

Research shows that Semaglutide, a drug that helps control blood sugar levels, is effective in reducing body weight and improving blood sugar control in people with type 2 diabetes. Additionally, preliminary observations suggest it may also help reduce body weight and improve blood sugar control in individuals with spinal cord injury. ^{1 2 3 4 5}

Is semaglutide safe for humans?

Semaglutide, used under names like Rybelsus, Ozempic, and Wegovy, has been tested in many people with type 2 diabetes and is generally considered safe. It has a similar safety profile to other drugs in its class and does not increase heart-related risks compared to a placebo. ^{1 3 4 6 7}

How is the drug semaglutide unique for treating type 2 diabetes and spinal cord injury?

Semaglutide is unique because it is a once-weekly injection that not only helps control blood sugar levels in type 2 diabetes but also aids in weight loss, which can be beneficial for individuals with spinal cord injury who are overweight or obese. Its mechanism as a glucagon-like peptide-1 (GLP-1) receptor agonist helps improve glycemic control and reduce body weight more effectively than some other diabetes treatments. ^{1 8 9 10 11}

Research Team

Marzieh Salehi, MD, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Semaglutide (GLP-1R Agonist)

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.

Participant Groups

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 Canada, Japan for the following indications:

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

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+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

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]

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]

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]

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 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]

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]

References

1. England 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. [2023]

2. England 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. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

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

4. Japan pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]

7. United States 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

GREATER COMBINED REDUCTIONS IN HbA1C ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. [2022]

10. England 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. [2020]

11. Belgium pubmed.ncbi.nlm.nih.gov

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