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GLP-1 Receptor Agonist
Dulaglutide for Type 2 Diabetes
Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of >85th percentile
Be younger than 18 years old
Must not have
Have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin within 90 days prior to screening
Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 26
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
"This trial is looking at different doses of dulaglutide in children with Type 2 Diabetes to see how well they work. The study will take around 8 months to complete."
Who is the study for?
This trial is for children with Type 2 Diabetes. The study will last approximately 8 months, but specific eligibility criteria are not provided.
What is being tested?
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.
What are the potential side effects?
While the exact side effects for this trial aren't listed, common ones for Dulaglutide may include nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 50 kg and my BMI is above the 85th percentile.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have taken diabetes medication other than metformin or basal insulin in the last 3 months.
Select...
I or my family have a history of MTC or MEN2.
Select...
I've had a severe low blood sugar episode or didn't notice my low blood sugar at least once in the last 6 months.
Select...
I have had chronic pancreatitis or issues with my gallbladder.
Select...
I have had diabetic ketoacidosis or hyperosmolar syndrome after being diagnosed with Type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DulaglutideExperimental Treatment1 Intervention
Participants will receive dulaglutide subcutaneously (SC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dulaglutide
2020
Completed Phase 4
~6610
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,329 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,786 Total Patients Enrolled