Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBGS | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dulaglutide | Experimental | Participants will receive dulaglutide subcutaneously (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85724 | United States |
Not provided
| Label | URL |
|---|---|
| A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants with Type 2 Diabetes Mellitus (AWARD-PEDS PLUS) | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Arkansas Childrens Hospital | Recruiting | Little Rock | Arkansas | 72202-3500 | United States |
|
| Division of Endocrinology, Diabetes, and Metabolism | Recruiting | Los Angeles | California | 90027 | United States |
|
| UCLA Mattel Children's Hospital | Recruiting | Los Angeles | California | 90095 | United States |
|
| University of California, San Francisco | Recruiting | San Francisco | California | 94158 | United States |
|
| Children's Hospital of Colorado | Not yet recruiting | Denver | Colorado | 80045 | United States |
|
| Yale Diabetes Research | Recruiting | New Haven | Connecticut | 06511 | United States |
|
| Emerson Clinical Research Institute | Recruiting | Washington D.C. | District of Columbia | 20009 | United States |
|
| Children's National Medical Center | Not yet recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| Nemours Children's Health | Recruiting | Jacksonville | Florida | 32207 | United States |
|
| D&H National Research Centers, Inc | Recruiting | Miami | Florida | 33155 | United States |
|
| AdventHealth Orlando | Recruiting | Orlando | Florida | 32803 | United States |
|
| D&H Tamarac Research Center, LLC | Recruiting | Tamarac | Florida | 33321 | United States |
|
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
|
| Children's Healthcare of Atlanta - Center for Advanced Pediatrics | Recruiting | Atlanta | Georgia | 30329 | United States |
|
| Centricity Research Columbus Endocrinology | Recruiting | Columbus | Georgia | 31904 | United States |
|
| St. Luke's Children's Endocrinology and Diabetes | Recruiting | Boise | Idaho | 83712 | United States |
|
| University of Illinois at Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
|
| Center for Diabetes and Metabolic Diseases Indiana University | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
|
| University of Iowa Stead Family Children's Hospitals | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| Norton Children's Endocrinology | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| Johns Hopkins University School of Medicine | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| University of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216 | United States |
|
| University of New Mexico Hospital | Recruiting | Albuquerque | New Mexico | 87106 | United States |
|
| WBMD Pediatrics | Recruiting | Buffalo | New York | 14203 | United States |
|
| Cohen Children's Medical Center Division of Pediatric Endocrinology | Recruiting | Hyde Park | New York | 11042 | United States |
|
| SUNY Upstate Medical University | Recruiting | Syracuse | New York | 13210 | United States |
|
| UNC Children's Hospital | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
|
| Childrens Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Cleveland Clinic Childrens Outpatient Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| St Christophers Hospital For Children | Recruiting | Philadelphia | Pennsylvania | 19134 | United States |
|
| Prisma Health Pediatric Endocrinology | Recruiting | Columbia | South Carolina | 29203 | United States |
|
| Prisma Health Midlands | Recruiting | Greenville | South Carolina | 29615 | United States |
|
| Research Institute of Dallas | Recruiting | Dallas | Texas | 75231 | United States |
|
| Texas Childrens Hospital | Recruiting | Houston | Texas | 77030 | United States |
|
| UT Health Houston | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
|
| Children's Wisconsin - Milwaukee Campus | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Not yet recruiting | Buenos Aires | C1425 | Argentina |
|
| Centro de Investigaciones Médicas Mar del Plata | Not yet recruiting | Mar del Plata | B7600FYK | Argentina |
|
| INECO Neurociencias Oroño | Not yet recruiting | Rosario | 2000 | Argentina |
|
| Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L | Not yet recruiting | San Miguel de Tucumán | T4000IHE | Argentina |
|
| Go Centro Medico San Nicolás | Not yet recruiting | San Nicolás | 2900 | Argentina |
|
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares | Not yet recruiting | Ciudad Madero | 89440 | Mexico |
|
| Hospital Angeles (HA) - Puebla | Not yet recruiting | Puebla City | 72190 | Mexico |
|
| Clínica Cemain | Not yet recruiting | Tampico | 89210 | Mexico |
|
| Innovacion y Desarrollo de Estrategias en Salud SA de CV | Not yet recruiting | Tlalpan | 14090 | Mexico |
|
| Arké SMO S.A de C.V | Not yet recruiting | Veracruz | 91910 | Mexico |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555680 | dulaglutide |
Not provided
Not provided
Not provided