RightFit
RecruitingPhase 3

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

A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests 3.0 mg and 4.5 mg doses of dulaglutide in children and teens with Type 2 diabetes. It aims to learn about more dosing options. Taking part lasts about 8 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Type 2 diabetes treated with diet, exercise, and metformin, basal insulin (long-acting insulin), or both.
  • Have used the same dose of metformin and/or basal insulin for at least 8 weeks before screening.
  • Weigh at least 50 kilograms (about 110 pounds).
  • Have a body mass index (BMI), a measure of weight compared with height, above the 85th percentile.

Who can't join

  • Have Type 1 diabetes.
  • Used blood sugar-lowering drugs other than metformin, basal insulin, or dulaglutide within 8 weeks before screening.
  • Had diabetic ketoacidosis (dangerous acid buildup in the blood) or hyperosmolar syndrome (very high blood sugar with severe fluid loss) after the Type 2 diabetes diagnosis.
  • Had severe low blood sugar, or low blood sugar without noticing warning signs, at least once in the past 6 months.
  • You or a family member have had medullary thyroid carcinoma (a type of thyroid cancer) or MEN2 (a condition that can cause tumors in hormone-making glands).
  • Have had long-lasting, repeated, or unexplained pancreatitis (swelling of the pancreas), or have known gallbladder disease.
  • Used prescription or over-the-counter medicines that promote weight loss within 8 weeks before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 Criteria: * Have Type 1 diabetes * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening * After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome * Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening

Study sites (41)

AR

AZ

CA

CO

CT

DC

FL

GA

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics · Atlanta, GA 30329Daniel Hsia · Principal investigatorMore trials in Atlanta
  • Centricity Research Columbus Endocrinology · Columbus, GA 31904Steven Leichter · Principal investigatorMore trials in Columbus

IA

ID

IL

IN

KY

MD

MS

NC

NM

NY

OH

OK

PA

SC

TX

UT

WA

WI