20 Participants NeededMy employer runs this trial

Semaglutide for Type 2 Diabetes

(GLOW Trial)

TI
JZ
Overseen ByJaafer Zaino
Age: 65+
Sex: Female
Trial Phase: Phase 3
Sponsor: Emory University
Must be taking: GLP-1 receptor agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a diabetes medication called semaglutide on muscle and bone health in older women with type 2 diabetes. Researchers aim to determine if using this treatment for six months can improve muscle strength. Participants will receive semaglutide as part of their regular care and will undergo tests such as hand grip strength assessments and bone scans. Women over 65 with type 2 diabetes who do not have osteoporosis or other serious health conditions may be eligible to join. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you've used certain diabetes medications like GLP-1RA, GIP analogues, pioglitazones, or DPP-4 inhibitors in the last 6 months. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study found semaglutide safe for people with type 2 diabetes, with most tolerating it well. Some experienced mild side effects like nausea and diarrhea, common with this type of treatment, while serious problems were rare.

Another study showed that semaglutide might slightly increase heart rate in about 16% of people over two years. However, it also reduces the risk of major heart issues, so the benefits often outweigh the risks.

Overall, semaglutide is considered safe for managing type 2 diabetes, as demonstrated by its FDA approval for this use. Participants in clinical trials have generally managed it well with standard medical advice.12345

Why do researchers think this study treatment might be promising for type 2 diabetes?

Semaglutide is unique because it is a GLP-1 receptor agonist, which offers a different approach compared to traditional type 2 diabetes treatments like metformin or sulfonylureas. Unlike these standard options, semaglutide not only helps in lowering blood sugar but also has been shown to aid in weight loss and improve heart health. Researchers are excited about semaglutide because it provides a dual benefit of managing blood sugar levels while also potentially reducing cardiovascular risks, which is a major concern for people with type 2 diabetes.

What evidence suggests that Semaglutide might be an effective treatment for type 2 diabetes?

Research has shown that semaglutide effectively manages type 2 diabetes and aids in weight loss. Many patients experience significant weight loss, with some losing more than 15% of their body weight. It also helps control blood sugar levels, with nearly half of the users reaching a healthy range. Additionally, semaglutide may reduce heart-related risks, which is crucial for people with diabetes. These benefits suggest that semaglutide could improve overall health and fitness, especially in older adults. Participants in this trial will receive semaglutide as part of their routine clinical care. The study will observe metabolic, musculoskeletal, and functional changes associated with ongoing therapy over a 6-month period.36789

Who Is on the Research Team?

TI

Thaer Idrees, MD, FSSCI

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for postmenopausal women aged 65 or older with type 2 diabetes, a BMI between 27 and 40, and no osteoporosis. Participants must be able to follow study procedures and not have certain medical conditions or treatments that could affect bone or muscle health.

Inclusion Criteria

Willingness and ability to comply with all study procedures, including fasting requirements
Able to provide informed consent and participate in all study assessments
Body Mass Index (BMI) between 27 kg/m² to 40 kg/m²
See 4 more

Exclusion Criteria

Presence of prosthesis or devices in the spine or hip
Inability to comply with the treatment protocol or understand the consent form
I have osteoporosis diagnosed in the past year or am taking osteoporosis medication.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLP-1 RA therapy as part of their routine clinical care for 6 months

6 months
Baseline, week 4, week 8, week 12, week 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide

Trial Overview

The study tests the effects of semaglutide (a GLP-1 RA therapy) over six months on muscle strength and bone health in older women with type 2 diabetes. Participants will receive the medication as part of their usual care while undergoing various assessments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Type 2 Diabetics on SemaglutideExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41093600/

a randomized pragmatic clinical trial

Semaglutide was associated with larger reductions in body weight at year 1 (-3.57% vs -1.91%; ETD (95% CI): -1.65% (-2.92% to -0.39%); p=0.010) ...

1733-P: Two-Year Real-World Effectiveness of Semaglutide in ...

Body weight reductions of ≥5%, ≥10%, ≥15%, and ≥20% from baseline at 2 years were observed in 90.5%, 69.8%, 46.9%, and 29.6% of patients, ...

Once-Weekly Semaglutide in Adults with Overweight or ...

Overall, 94.3% of the participants completed the trial, 91.2% had a body-weight assessment at week 68, and 81.1% adhered to treatment (Fig. S2).

Semaglutide - StatPearls - NCBI Bookshelf

The Rybelsus® tablet brand demonstrates efficacy in improving glycemic control in patients with type 2 diabetes mellitus (T2DM). Ozempic® ...

Semaglutide use in people with obesity and type 2 diabetes ...

The median endpoint for HbA1c was 7.10%, with 1310 participants (48.87% of individuals on semaglutide) achieving an HbA1c of less than 7%; 824 ...

Comparative Effectiveness and Safety of Oral Versus ... - PMC

Outcomes included changes in HbA1c, body weight, and treatment discontinuation due to adverse effects. Pooled analysis indicated that ...

Real‐world safety profile of once‐weekly semaglutide in ...

Additionally, a CV outcomes trial reported an increased heart rate of more than 10 bpm in 16% of patients after 2 years of OW semaglutide ...

NCT07046273 | Phase III Clinical Study on the Efficacy and ...

Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes · Study Overview · Contacts and ...

Chronic Weight Management Trial Results | Wegovy ...

Type 2 Diabetes: Wegovy® tablets have not been studied for weight reduction in adults with T2D and obesity or overweight. Administration of Wegovy ...