Semaglutide for Type 2 Diabetes

(GLOW Trial)

Overseen By Jaafer Zaino

Age: 65+

Sex: Female

Trial Phase: Phase 3

Sponsor: Emory University

Must be taking: GLP-1 receptor agonists

Must not be taking: GIP analogues, Pioglitazones, DPP-4 inhibitors

Disqualifiers: Type 1 diabetes, Osteoporosis, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to learn how GLP-1 receptor agonist therapy affects muscle and bone health in older females over age 65 with type 2 diabetes.

The main question it aims to answer is whether or not 6 months of GLP-1 RA therapy affects muscle strength.

Participants will:

* Receive GLP-1 RA therapy as part of their routine clinical care

* Complete muscle strength assessments (hand grip strength, Timed Up and Go test)

* Provide blood samples for bone turnover markers

* Undergo bone mineral density testing

Who Is on the Research Team?

Thaer Idrees, MD, FSSCI

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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

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.

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

How Is the Trial Designed?

Group I: Type 2 Diabetics on Semaglutide Experimental Treatment 1 Intervention

Participants will receive a GLP-1 receptor agonist (GLP-1 RA) prescribed as part of their routine clinical care. Dosing will follow standard clinical practice and will be titrated to each participant's maximum tolerated dose. The study will observe metabolic, musculoskeletal, and functional changes associated with ongoing GLP-1 RA therapy over a 6-month period.

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+