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Dulaglutide for Pediatric Type 2 Diabetes

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

Recruiting Phase 3 Interventional Study
Type 2 Diabetes
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
10 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
55 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for children with Type 2 diabetes to test different doses of a medication called dulaglutide. Participation will last about 8 months and requires being treated with certain diabetes medications.

Are You a Good Fit for This Trial?
Must be taking MetforminBasal insulin
Rules you out Type 1 diabetesDiabetic ketoacidosisHyperosmolar syndromeSevere hypoglycemiaHypoglycemic unawarenessMedullary thyroid carcinomaMultiple endocrine neoplasia syndrome type 2Pancreatitis

You may be able to join if

  • I have been diagnosed with Type 2 diabetes
  • I weigh at least 50 kilograms
  • I follow a diet and exercise plan
  • I have been taking metformin or basal insulin for at least 8 weeks
  • My metformin or basal insulin dose has been stable for at least 8 weeks
  • I have a Body Mass Index (BMI) over the 85th percentile

You may not be able to join if

  • I have Type 1 diabetes
  • I have had severe low blood sugar or not realized I had low blood sugar in the last 6 months
  • I have a personal or family history of certain thyroid cancers
  • I have had pancreatitis or gallbladder disease
  • I have had diabetic ketoacidosis or hyperosmolar syndrome since my diabetes diagnosis
  • I have taken any weight loss medications in the last 8 weeks
  • I have received any glucose-lowering agents other than metformin, basal insulin, or dulaglutide in the last 8 weeks

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

Trial Locations

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Eligibility Criteria
Inclusion Criteria: * Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening. * Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile Exclusion…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT

NCT ID: NCT06739122 Source: ClinicalTrials.gov