Liraglutide for Diabetes

Overseen By Adrian Vella, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Insulin

Must not be taking: GLP-1 receptor agonists

Disqualifiers: Age, HbA1c, Pregnancy, Surgery, Illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of liraglutide, a medication, for people with diabetes. Researchers aim to determine if this treatment can help control blood sugar levels in individuals with both type 1 and type 2 diabetes. Participants will receive either liraglutide or a placebo, which is a harmless substance resembling the real medicine. Individuals with type 1 or type 2 diabetes who use insulin might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important diabetes research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have used GLP-1 receptor agonists in the past year, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that liraglutide lowered systolic blood pressure and reduced episodes of very low blood sugar in people with type 1 diabetes. Another study showed that adding liraglutide to insulin treatment improved blood sugar control, as measured by HbA1c levels. It also reduced the total amount of insulin needed and led to weight loss in these patients.

For those with type 2 diabetes, research suggests liraglutide might lower the risk of major heart problems and death. One study showed that fewer people died in the liraglutide group compared to those who took a placebo. Another study found that people taking liraglutide experienced fewer episodes of very low blood sugar than those on a placebo.

These studies suggest that liraglutide is generally well-tolerated and may offer safety benefits for people with both type 1 and type 2 diabetes. ^{1 2 3 4 5}

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

Researchers are excited about Liraglutide for diabetes because it offers a new approach compared to standard treatments like insulin and metformin. Unlike these common treatments, Liraglutide is a GLP-1 receptor agonist, which means it mimics a hormone that helps regulate blood sugar levels by enhancing insulin secretion, slowing gastric emptying, and reducing appetite. This multi-faceted mechanism not only helps control blood sugar but may also support weight loss, which is particularly beneficial for individuals with type 2 diabetes. Additionally, Liraglutide is administered via a simple daily injection, offering a straightforward routine for patients.

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

This trial will evaluate liraglutide's effectiveness for both type 1 and type 2 diabetes. Participants in the liraglutide arms will self-administer 0.6mg liraglutide syringes daily. Studies have shown that liraglutide can help control blood sugar, reduce body weight, and lower insulin needs in people with type 1 diabetes. It also helps lower blood pressure, which is important for preventing complications. For type 2 diabetes, liraglutide is known to lower blood sugar levels and aid in weight loss. Additionally, it can reduce the risk of heart problems, making it a strong option for managing diabetes. ^{1 3 4 6 7}

Who Is on the Research Team?

Adrian Vella, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 or Type 2 Diabetes who are interested in how different treatments affect their insulin-producing cells. Specific eligibility criteria were not provided, so participants should inquire about detailed requirements.

Inclusion Criteria

I have diabetes and am treated with insulin.

Exclusion Criteria

HbA1c > 10.0%

I am younger than 25 or older than 70.

I am not pregnant at the time of joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or 0.6mg Liraglutide daily for 30 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liraglutide

Trial Overview The study tests the effects of a GLP-1 receptor agonist (Liraglutide Pen Injector) versus saline injections on the function of insulin-producing cells in diabetic patients. It aims to understand if and how these treatments alter islet GLP-1 levels differently in Type 1 and Type 2 Diabetes.

How Is the Trial Designed?

Group I: Type 1 diabetes - Liraglutide arm Active Control 1 Intervention

Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase

Group II: Type 2 diabetes - Liraglutide arm Active Control 1 Intervention

Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase

Group III: Type 1 diabetes - Placebo arm Placebo Group 1 Intervention

Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase

Group IV: Type 2 diabetes - Placebo arm Placebo Group 1 Intervention

Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01612468

NCT01612468 | Liraglutide in Type 1 Diabetes Several studies have shown that liraglutide lowers systolic blood pressure. Dysregulation increases the risk of microvascular complications in type 1 diabetes ...

2. diabetesjournals.org diabetesjournals.org/care/article/38/12/2250/28919/Twelve-Week-Treatment-With-Liraglutide-as-Add-on

Twelve-Week Treatment With Liraglutide as Add-on to Insulin ... Liraglutide significantly reduces body weight and insulin requirements but has no additional effect on HbA1c in normal-weight patients with type 1 diabetes ...

3. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(15)00436-2/abstract

Efficacy and safety of liraglutide for overweight adult ... Liraglutide was associated with reductions in hypoglycaemic events, bolus and total insulin dose, and bodyweight, and increased heart rate.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1411892

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in ... In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9292057/

Efficacy and safety of liraglutide in type 1 diabetes by ... The ADJUNCT trials confirmed that liraglutide as an adjunct to insulin improved glycaemic control, and reduced body weight and exogenous insulin requirements.

6. diabetesjournals.org diabetesjournals.org/care/article/39/10/1702/162/Efficacy-and-Safety-of-Liraglutide-Added-to

Efficacy and Safety of Liraglutide Added to Insulin Treatment ... Liraglutide added to insulin therapy reduced HbA1c levels, total insulin dose, and body weight in a population that was generally representative ...

7. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15889

Liraglutide enhances insulin secretion and prolongs the ... Liraglutide enhances insulin secretion and prolongs the remission period in adults with newly diagnosed type 1 diabetes (the NewLira study)