Semaglutide + Exercise for Type 2 Diabetes

(MOTIVATE Trial)

OG
Overseen ByOlivia Ghosh-Swaby, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 aims to determine how exercise and the diabetes medication semaglutide can enhance brain health and physical function in older adults with Type 2 diabetes. Researchers will assign participants to one of four groups, each testing different combinations of exercise and diabetes care, to identify the most effective approach. Ideal participants are those aged 65 and older with Type 2 diabetes who do not engage in regular resistance exercise more than once a week. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment can benefit a broader range of patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used a GLP-1 receptor agonist in the past 6 months. It's best to discuss your current medications with the trial team.

What is the safety track record for these treatments?

Studies have shown that semaglutide is generally well-tolerated in adults with Type 2 diabetes. Research indicates that the most common side effects include nausea, vomiting, diarrhea, and stomach pain. These side effects are usually mild and tend to decrease over time. No new safety concerns have emerged, suggesting that semaglutide is safe for long-term diabetes management.

When combined with exercise, semaglutide has not presented any unexpected safety issues. Those taking semaglutide should be aware that it might affect how they feel during exercise, with some reports of low blood sugar (hypoglycemia) in certain situations. However, moderate exercise like walking or light weightlifting remains recommended and safe for most people on semaglutide.

For those considering joining a trial with semaglutide and exercise, understanding these potential side effects can aid in making an informed decision. Always consult healthcare providers if any concerns arise.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about combining semaglutide with specific exercise regimens for Type 2 diabetes because it offers a novel approach to managing the condition. Unlike standard treatments that focus mainly on glucose-lowering medications like metformin or lifestyle changes, semaglutide is a GLP-1 receptor agonist that not only helps control blood sugar levels but also aids in weight loss. The study explores the effectiveness of pairing semaglutide with either resistance or balance-and-tone exercises, potentially enhancing the overall benefits of the treatment. This combination could lead to improved metabolic outcomes and provide a comprehensive strategy for managing diabetes beyond what current options offer.

What evidence suggests that this trial's treatments could be effective for Type 2 diabetes?

Research has shown that semaglutide effectively manages Type 2 diabetes. Studies have found that it lowers blood sugar levels and leads to significant weight loss. For example, participants taking semaglutide lost about 15% of their body weight over 68 weeks. It also benefits heart health by lowering cholesterol levels. In this trial, some participants will receive semaglutide combined with exercise, which may enhance these positive effects, improving both physical health and possibly brain health in older adults with Type 2 diabetes. Other participants will receive standard care combined with exercise, without semaglutide, to compare the outcomes.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older with type 2 diabetes (A1c ≥7%), who live in the community, are able to exercise safely, have good basic thinking skills, and can speak English. People can't join if they already exercise regularly, have dementia or serious mental illness, certain medical conditions, recent heart attack or stroke, severe nerve damage, or eye problems.

Inclusion Criteria

Informed consent obtained before any trial-related activities
Community-dwelling
Score >24/30 on the Mini-Mental State Exam (MMSE)
See 10 more

Exclusion Criteria

I am taking medications for mental health conditions other than depression.
Have engaged regularly (>1/week) in aerobic or resistance exercise within the past 6 months
Have a neurodegenerative disease (i.e., dementia) or psychiatric condition
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive supervised exercise sessions three times per week for 32 weeks, with some receiving weekly semaglutide injections for 16 weeks

32 weeks
3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Balance and Tone (BAT) Exercise
  • Moderate-Intensity Resistance Exercise
  • Semaglutide

Trial Overview

The study tests how supervised exercise programs and the diabetes medication semaglutide—alone or together—affect brain health and physical function in older adults with type 2 diabetes. Participants are randomly assigned to one of four groups: different types of exercise training, semaglutide treatment plus standard care.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Resistance Exercise + SemaglutideExperimental Treatment2 Interventions
Group II: Standard of Care + Resistance ExerciseActive Control1 Intervention
Group III: Semaglutide + Balance and Tone ExerciseActive Control2 Interventions
Group IV: Standard of Care + Balance and Tone ExerciseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials
270
Recruited
62,500+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39248157/

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

This real-world data analysis showed that semaglutide was well tolerated and that, for a large population, it effectively reduced BMI, body weight and HbA1c.

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).

a randomized pragmatic clinical trial

In SEPRA, greater improvement with semaglutide versus alternative treatment was observed on measures of glycemic control, body weight, and some ...

Pharmacoeconomic Review - Semaglutide (Wegovy) - NCBI

Treatment effectiveness for semaglutide was derived from the SELECT and SUSTAIN-6 trials and relates to temporary prediabetes reversal and changes in BMI, ...

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 ...

Semaglutide: Double-edged Sword with Risks and Benefits

Risk of stroke in patients with type 2 diabetes receiving semaglutide or a dipeptidyl peptidase-4 inhibitor: a real-world US claims database analysis.

Safety & Side Effects | Ozempic® (semaglutide) injection & ...

The most common adverse reactions reported in ≥5% of patients taking Ozempic® injection and Ozempic® tablets are nausea, vomiting, diarrhea, abdominal pain, ...

FDA's Concerns with Unapproved GLP-1 Drugs Used for ...

Dosing concerns with compounded semaglutide and tirzepatide. FDA received multiple reports of adverse events, some requiring hospitalization, ...

Semaglutide (subcutaneous route) - Side effects & dosage

Semaglutide injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control your blood sugar.

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39118222/

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

No new safety concerns were identified, highlighting that OW semaglutide is well tolerated by adults with T2D and in subpopulations in routine clinical ...