Dulaglutide for Type 2 Diabetes

Recruiting at 32 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must be taking: Metformin, Basal insulin

Must not be taking: Weight loss drugs

Disqualifiers: Type 1 diabetes, Severe hypoglycemia, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different doses of dulaglutide for children and teens with Type 2 Diabetes. The goal is to determine how well these doses manage blood sugar levels when combined with diet, exercise, and a stable dose of metformin or basal insulin. The trial seeks participants who have Type 2 Diabetes, follow a stable diabetes treatment plan, and have a body weight over 50 kilograms with a BMI above the 85th percentile. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for Type 2 Diabetes.

Will I have to stop taking my current medications?

You can continue taking metformin and/or basal insulin as long as your dose has been stable for at least 8 weeks before the trial. However, you should not have taken any other glucose-lowering medications or weight loss drugs in the 90 days before the trial.

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

Research has shown that dulaglutide, a medication for type 2 diabetes, is generally well-tolerated. Studies have found that the most common side effects include nausea, diarrhea, and occasional stomach pain, affecting about 11.8% of users. Less common issues include fatigue and minor reactions at the injection site, impacting around 8.9% of participants. Although dulaglutide is already approved for adults with type 2 diabetes, this trial examines new doses for children. The existing approval for adults suggests the treatment is considered safe, offering some reassurance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Dulaglutide is unique because it is a once-weekly injection that helps manage Type 2 Diabetes by mimicking a hormone called GLP-1, which lowers blood sugar levels and can aid in weight loss. Unlike many existing treatments that require daily administration, dulaglutide offers convenience and potentially better adherence for patients. Researchers are excited about its dual benefits for glucose control and weight management, which are crucial for individuals with Type 2 Diabetes.

What is the effectiveness track record for dulaglutide in treating Type 2 Diabetes?

Studies have shown that dulaglutide effectively lowers blood sugar levels in people with Type 2 Diabetes. It reduces HbA1c, a measure of long-term blood sugar levels, and also lowers fasting blood sugar. Research indicates that dulaglutide can aid in weight loss and is considered safe based on existing knowledge. When compared directly to other treatments like insulin, dulaglutide often performs better at reducing blood sugar and lowering the risk of low blood sugar (hypoglycemia). For young people, dulaglutide has proven more effective than a placebo in lowering glycated hemoglobin, an important marker of blood sugar control. ^{3 6 7 8 9}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for children with Type 2 Diabetes. The study will last approximately 8 months, but specific eligibility criteria are not provided.

Inclusion Criteria

I manage my Type 2 diabetes with diet, exercise, and stable doses of metformin or insulin.

I weigh at least 50 kg and my BMI is above the 85th percentile.

Exclusion Criteria

I have taken diabetes medication other than metformin or basal insulin in the last 3 months.

I have had chronic pancreatitis or issues with my gallbladder.

I have not used weight loss drugs in the last 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dulaglutide subcutaneously for Type 2 Diabetes management

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dulaglutide

Trial Overview The study is testing two higher doses of Dulaglutide (3.0 mg and 4.5 mg) to see how well they work in young patients with Type 2 Diabetes.

How Is the Trial Designed?

Group I: Dulaglutide Experimental Treatment 1 Intervention

Participants will receive dulaglutide subcutaneously (SC)

Dulaglutide is already approved in United States, European Union for the following indications:

Approved in United States as Trulicity for:

• Type 2 diabetes mellitus
• Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors

Approved in European Union as Trulicity for:

• Type 2 diabetes mellitus
• Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Dulaglutide (Trulicity) is a once-weekly GLP-1 agonist that has been approved for the treatment of type 2 diabetes, providing a convenient dosing schedule for patients.

As the third GLP-1 agonist available, dulaglutide offers an effective option for managing blood sugar levels in individuals with type 2 diabetes, contributing to improved glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulaglutide (Trulicity): The Third Once-Weekly GLP-1 Agonist. Smith, LL., Mosley, JF., Parke, C., et al.[2020]

Tofacitinib is the first targeted synthetic DMARD approved for rheumatoid arthritis, functioning as a Janus kinase (JAK) inhibitor that reduces T-cell activation and inflammation, leading to decreased joint damage.

The safety and efficacy of tofacitinib have been evaluated in six phase 3 trials, demonstrating its effectiveness as a treatment option for RA, either alone or in combination with other non-biologic DMARDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis. Lundquist, LM., Cole, SW., Sikes, ML.[2022]

Dulaglutide (Trulicity™) is a long-acting GLP-1 receptor agonist specifically designed for treating type 2 diabetes, demonstrating a novel mechanism of action by mimicking the effects of the GLP-1 hormone.

The drug has received approval for subcutaneous use in the US and is recommended for approval in the EU, indicating its efficacy and safety profile in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulaglutide: first global approval. Sanford, M.[2021]

Dulaglutide (Trulicity™) is an effective once-weekly treatment for type 2 diabetes, showing significant improvements in glycemic control compared to oral metformin and non-inferiority to daily liraglutide in trials lasting up to 104 weeks.

It is generally well tolerated with a low risk of hypoglycemia, although gastrointestinal side effects like nausea and diarrhea are common; it also helps with weight loss, particularly at the higher dose of 1.5 mg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulaglutide: A Review in Type 2 Diabetes. Burness, CB., Scott, LJ.[2015]

Dulaglutide (Trulicity®) is an effective once-weekly treatment for type 2 diabetes, showing greater glucose-lowering effects compared to metformin, sitagliptin, exenatide, and insulin glargine in Phase III clinical trials involving various patient backgrounds.

It is considered non-inferior to liraglutide, another GLP-1 receptor agonist, and is currently reimbursed in Belgium for patients who have not achieved adequate control with dual oral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dulaglutide (Trulicity®), a new once-weekly agonist of glucagon-like peptide-1 receptors for type 2 diabetes]. Scheen, AJ.[2016]

Tofacitinib is effective in treating rheumatoid arthritis, showing significantly higher response rates (ACR20 and ACR50) compared to placebo in a review of 8 clinical trials involving 3,791 patients, with effects maintained up to 24 weeks.

While tofacitinib is generally well tolerated, it can lead to changes in blood counts and liver function, indicating the need for regular monitoring of these parameters during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systematic review and meta-analysis. He, Y., Wong, AY., Chan, EW., et al.[2023]

Everolimus, a proliferation-signal inhibitor, shows potential as a treatment option for rheumatoid arthritis patients who cannot use newer biologic agents, offering a convenient once-daily oral dosing schedule.

Further research is needed to confirm the effectiveness and safety profile of everolimus in modifying the disease and to understand its potential advantages over traditional oral DMARDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for everolimus in the treatment of RA? Olsen, NJ.[2021]

Tofacitinib, a Janus kinase inhibitor, was successfully used to induce remission in a middle-aged woman with postpartum type II refractory coeliac disease (RCD) after she failed multiple other treatments.

This case represents the first documented instance of RCD remission in response to tofacitinib, suggesting it may be a promising new treatment option for this serious condition associated with high mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful novel use of tofacitinib for type II refractory coeliac disease. Grewal, JK., Kassardjian, A., Weiss, GA.[2022]

Disease-modifying anti-rheumatic drugs (DMARDs) are crucial in treating rheumatoid arthritis as they can modify the disease course and sometimes induce clinical remission, unlike traditional symptomatic drugs that only relieve pain and inflammation.

The review highlights the historical development of various DMARDs, including methotrexate and combination therapies, which have evolved from a progressive treatment approach to more aggressive strategies involving multiple drugs to enhance efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A short history of anti-rheumatic therapy - VI. Rheumatoid arthritis drugs]. Pasero, G., Marson, P.[2019]

Dulaglutide (Trulicity®) is an effective once-weekly treatment for adults with type 2 diabetes, showing good tolerance and efficacy both as a standalone therapy and in combination with other diabetes medications, even in high-risk patients.

In the REWIND trial, dulaglutide significantly reduced the risk of major adverse cardiac events over a median follow-up of 5.4 years, highlighting its cardiovascular benefits alongside glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulaglutide: A Review in Type 2 Diabetes. Scott, LJ.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7324465/

Real-World Effectiveness of Dulaglutide in Patients with ... Studies consistently demonstrated that dulaglutide improved glycemic control by reducing HbA1c levels from pre-treatment. Furthermore, treatment ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589936824000161

Comparative efficacy and safety of weekly dulaglutide ... Dulaglutide, particularly at higher doses, demonstrates superior efficacy in lowering hemoglobin A1C and reducing hypoglycemia risk compared to Icodec insulin.

3. e-dmj.org e-dmj.org/journal/view.php?number=2809

Safety and Effectiveness of Dulaglutide in the Treatment ... Dulaglutide resulted in reductions in HbA1c, fasting blood glucose, and body weight. • Adverse events were consistent with the known safety ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14823

The Real‐World Observational Prospective Study of Health ... In the real-world setting, dulaglutide and liraglutide cohorts achieved good persistence with similarly improved glycaemic control that was ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2204601

Once-Weekly Dulaglutide for the Treatment of Youths with ... Results from this double-blind, randomized, phase 3 trial showed that dulaglutide treatment was superior to placebo in reducing the glycated hemoglobin level ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7896253/

Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus ... To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.

7. mayoclinic.org mayoclinic.org/drugs-supplements/dulaglutide-subcutaneous-route/description/drg-20122526

Dulaglutide (subcutaneous route) - Side effects & dosage Dulaglutide injection is used to treat type 2 diabetes mellitus. ... Safety and efficacy have not been established. Geriatric. Appropriate ...

8. trulicity.lilly.com trulicity.lilly.com/how-to-use/side-effects

Side Effects of Trulicity (dulaglutide) & How to Manage Them The most common adverse reactions experienced with Trulicity are nausea, diarrhea, vomiting, abdominal pain, decreased appetite, indigestion and fatigue.

9. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/t/trulicityinj.pdf

New Zealand Data sheet 1. Trulicity (dulaglutide 1.5 mg/0.5 ... These studies were designed to assess safety and efficacy in patients across different stages of the type 2 diabetes mellitus treatment ...