Not currently recruiting at UCSF

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

a study on Diabetes Diabetes Type 2

Summary

Eligibility
for people ages 10-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Shylaja Sirinivasan
Headshot of Shylaja Sirinivasan
Shylaja Sirinivasan

Description

Summary

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.

Official Title

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

Keywords

Type 2 Diabetes, Diabetes Mellitus, Type 2 Diabetes Mellitus, Dulaglutide

Eligibility

You can join if…

Open to people ages 10-17

  • 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

You CAN'T join if...

  • Have Type 1 diabetes
  • Have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin 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

Locations

  • UCSF not yet accepting patients
    San Francisco California 94158 United States
  • Division of Endocrinology, Diabetes, and Metabolism not yet accepting patients
    Los Angeles California 90027 United States
  • Centricity Research Columbus Endocrinology accepting new patients
    Columbus Georgia 31904 United States
  • WBMD Pediatrics accepting new patients
    Buffalo New York 14203 United States

Lead Scientist at UCSF

  • Shylaja Sirinivasan
    I am a clinican-scientist and Assistant Professor of Pediatrics in the Division of Pediatric Endocrinology at UCSF. My clinical and scientific focus is on prediabetes and type 2 diabetes in youth. Specifically, I use pharmacologic and genetic approaches to evaluate pathophysiology and therapeutic strategies for youth with prediabetes and type 2 diabetes.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants with Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
ID
NCT06739122
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 55 study participants
Last Updated