Exercise + Liraglutide for Type 2 Diabetes

(ZQL007 Trial)

Overseen By Linda Jahn, RN, MEd

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Virginia

Must be taking: Oral hypoglycemics

Must not be taking: Insulin

Disqualifiers: Smoking, Hypertension, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and muscle capillary blood volume, improves vascular function in the larger conduit vessels, and enhances insulin's metabolic action in humans with Type 2 diabetes. Subjects will be randomized to one of the three groups: exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 16 weeks of intervention.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable dose of your medications for more than 4 months.

Is the combination of exercise and liraglutide safe for humans?

Liraglutide, used for type 2 diabetes and weight management, is generally safe with a low risk of low blood sugar and common side effects like nausea, which usually decrease over time. It is approved for use with diet and exercise, and safety has been demonstrated in controlled trials for obesity and diabetes. ^{1 2 3 4 5}

How does the treatment of exercise combined with the drug liraglutide differ from other treatments for type 2 diabetes?

This treatment is unique because it combines exercise with liraglutide, a drug that not only helps control blood sugar levels but also promotes weight loss and improves pancreatic function. Liraglutide is administered as a daily injection and is known for its low risk of causing low blood sugar, making it a safer option for some patients compared to other diabetes medications. ^{2 4 5 6 7}

What data supports the effectiveness of the drug liraglutide for managing type 2 diabetes?

Liraglutide, when used with diet and exercise, has been shown to improve blood sugar control and promote weight loss in people with type 2 diabetes. It is effective in reducing hemoglobin A1c levels and is generally well tolerated, with common side effects like nausea decreasing over time. ^{1 2 3 4 5}

Who Is on the Research Team?

Zhenqi Liu, MD

Principal Investigator

University of Virginia, Department of Endocrinoolgy

Are You a Good Fit for This Trial?

This trial is for adults aged 21-60 with Type 2 diabetes who have an A1C level of ≤8.5% and haven't used GLP-1RA or DPP4I medications. Participants should be on a stable dose of oral diabetes drugs for over four months, not taking insulin, non-smokers, with controlled blood pressure and BMI under 35. They must not have certain heart, lung, liver or kidney diseases, specific family cancer histories, vascular diseases or be pregnant.

Inclusion Criteria

I am between 21 and 60 years old.

I have been on the same dose of my medications for over 4 months.

Your A1C level is lower than 8.5%.

Exclusion Criteria

My family has a history of thyroid cancer or genetic syndromes affecting multiple glands.

My BMI is over 35.

I have a history of heart, lung, liver, or kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either exercise training, liraglutide treatment, or a combination of both for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Liraglutide

Trial Overview The study aims to see if exercise alone, the drug Liraglutide alone, or both combined can improve blood vessel function and insulin sensitivity in people with Type 2 diabetes. Participants will be randomly assigned to one of three groups and evaluated before and after the 16-week intervention period.

How Is the Trial Designed?

Group I: Liraglutide alone Experimental Treatment 1 Intervention

16 weeks of treatment

Group II: Exercise Alone Experimental Treatment 1 Intervention

16 weeks of treatment

Group III: Exercise + Liraglutide Experimental Treatment 2 Interventions

16 weeks of treatment

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Liraglutide (Victoza®) is an effective treatment for adults with type 2 diabetes, showing greater improvements in blood sugar control compared to placebo and other diabetes medications in multiple phase III trials.

It is generally well tolerated with a low risk of hypoglycemia, though common side effects include mild to moderate gastrointestinal issues like nausea and diarrhea, which tend to decrease over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide: a review of its use in the management of type 2 diabetes mellitus. Perry, CM.[2021]

Liraglutide is an effective treatment for type 2 diabetes, reducing hemoglobin A1c levels by 0.8% to 1.5%, and is safe for patients at risk of hypoglycemia due to its low incidence of this side effect.

It is particularly beneficial for overweight or obese patients, as it not only helps control blood sugar but also promotes weight loss of about 2%-4% of initial body weight, although nausea can occur but is typically manageable with careful dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pearls for initiating and utilizing liraglutide in patients with type 2 diabetes. Gross, B.[2015]

Liraglutide (Victoza) significantly improves glycaemic control in adults with type 2 diabetes, outperforming both placebo and other medications like rosiglitazone and insulin glargine in phase III studies.

It is generally well tolerated, with weight loss benefits and a low risk of hypoglycaemia, although gastrointestinal side effects like nausea are common but tend to decrease over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide: a review of its use in type 2 diabetes mellitus. Croom, KF., McCormack, PL.[2021]

Liraglutide, approved for Type 2 diabetes and chronic weight management, works by increasing insulin secretion and decreasing appetite, which helps promote weight loss.

Recent findings suggest that liraglutide may also protect against prediabetes and prevent bone loss by enhancing bone formation after weight loss, highlighting its broader health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide for Type 2 diabetes and obesity: a 2015 update. Iepsen, EW., Torekov, SS., Holst, JJ.[2015]

Liraglutide, now available at a higher dose of 3.0 mg for treating obesity, has been shown to effectively control appetite and promote weight loss when combined with diet and exercise, based on results from the SCALE studies.

The drug is already established for managing type 2 diabetes at lower doses, and its mechanism of action includes effects on the endocrine pancreas and appetite regulation in the hypothalamus, indicating a dual benefit for patients with obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[LIRAGUTIDE AT A DOSE OF 3.0 MG (SAXENDA): NEW INDICATION FOR THE TREATMENT OF OBESITY]. Scheen, AJ.[2016]

Liraglutide is an FDA-approved GLP-1 receptor agonist for treating type 2 diabetes, administered via subcutaneous injection, and can be used alone or with certain oral medications like metformin or glimepiride.

It is important to note that liraglutide is not recommended as a first-line treatment and is not approved for use in combination with insulin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide (Victoza) for type 2 diabetes. [2015]

Liraglutide is an effective treatment for type 2 diabetes, showing greater improvement in glycemic control compared to other incretin-based therapies, with sustained benefits observed over a period of up to 2 years.

The medication is generally well tolerated, with a low risk of hypoglycemia and mild to moderate gastrointestinal side effects that decrease with continued use, while also offering additional benefits like weight reduction and improved beta-cell function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide in type 2 diabetes mellitus. Baruah, MP., Chaudhury, T., Sethi, BK., et al.[2018]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Liraglutide: a review of its use in the management of type 2 diabetes mellitus. [2021]

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

Clinical pearls for initiating and utilizing liraglutide in patients with type 2 diabetes. [2015]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Liraglutide: a review of its use in type 2 diabetes mellitus. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Liraglutide for Type 2 diabetes and obesity: a 2015 update. [2015]

5. Belgium pubmed.ncbi.nlm.nih.gov

[LIRAGUTIDE AT A DOSE OF 3.0 MG (SAXENDA): NEW INDICATION FOR THE TREATMENT OF OBESITY]. [2016]

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

Liraglutide (Victoza) for type 2 diabetes. [2015]

7. India pubmed.ncbi.nlm.nih.gov

Liraglutide in type 2 diabetes mellitus. [2018]