Clinical trial NCT06739122: A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 55
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Week 26
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide
timeFrame: Predose through Week 30
measure: PK: Maximum Observed Concentration (Cmax) of Dulaglutide
timeFrame: Predose through Week 30
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 26
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 26
measure: Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 26
measure: Change from Baseline in the EQ-5D-Y-5L
timeFrame: Baseline, Week 26
measure: Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Childrens Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Division of Endocrinology, Diabetes, and Metabolism
state: California
city: Los Angeles
country: United States
facility: UCLA Mattel Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Yale Diabetes Research
state: Connecticut
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Nemours Children's Health
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers, Inc
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Tamarac
country: United States
facility: D&H Tamarac Research Center, LLC
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Endocrinology
state: Georgia
city: Boise
country: United States
facility: St. Luke's Children's Endocrinology and Diabetes
state: Idaho
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Louisville
country: United States
facility: Norton Children's Endocrinology
state: Kentucky
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
city: Buffalo
country: United States
facility: WBMD Pediatrics
state: New York
city: Hyde Park
country: United States
facility: Cohen Children's Medical Center Division of Pediatric Endocrinology
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: UNC Children's Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Childrens Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Childrens Outpatient Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Columbia
country: United States
facility: Prisma Health Pediatric Endocrinology
state: South Carolina
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: