| Trial ID: | L6102 |
| Source ID: | NCT06739122
|
| Associated Drug: |
Dulaglutide
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| Title: |
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
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| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Dulaglutide
|
| Outcome Measures: |
Primary: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration, 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, Baseline through Week 26 | Secondary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide, Predose through Week 30|PK: Maximum Observed Concentration (Cmax) of Dulaglutide, Predose through Week 30|Change from Baseline in Hemoglobin A1c (HbA1c), Baseline, Week 26|Percent Change from Baseline in Body Weight, Baseline, Week 26|Change from Baseline in Total Cholesterol, Baseline, Week 26|Change from Baseline in the EQ-5D-Y-5L, Baseline, Week 26|Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B), Baseline, Week 26
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
CHILD
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| Phases: |
PHASE3
|
| Enrollment: |
55
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2025-01-10
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| Completion Date: |
2026-07
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| Results First Posted: |
|
| Last Update Posted: |
2025-02-26
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| Locations: |
D&H National Research Centers, Inc, Miami, Florida, 33155, United States|D&H Tamarac Research Center, LLC, Tamarac, Florida, 33321, United States|Centricity Research Columbus Endocrinology, Columbus, Georgia, 31904, United States
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| URL: |
https://clinicaltrials.gov/show/NCT06739122
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