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NCT Number: NCT06739122

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulaglutide

Drug

Administered SC

Other names: LY2189265

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline through Week 26

    A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide

    Time frame: Predose through Week 30

  2. PK: Maximum Observed Concentration (Cmax) of Dulaglutide

    Time frame: Predose through Week 30

  3. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 26

  4. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 26

  5. Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 26

  6. Change from Baseline in the EQ-5D-Y-5L

    Time frame: Baseline, Week 26

  7. Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)

    Time frame: Baseline, Week 26

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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