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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBGC | Other Identifier | Eli Lilly and Company | |
| 2016-000361-22 | EudraCT Number |
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The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/0.75 milligram (mg) Dulaglutide | Experimental | Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE). |
|
| 0.75 mg Dulaglutide | Experimental | Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE. |
|
| 1.5 mg Dulaglutide | Experimental | Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline). | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Individual Doses) at Week 26 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39963952 | Derived | Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2. | |
| 35658022 | Derived | Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Perez M, Bismuth E, Dib S, Cho JI, Cox D; AWARD-PEDS Investigators. Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. N Engl J Med. 2022 Aug 4;387(5):433-443. doi: 10.1056/NEJMoa2204601. Epub 2022 Jun 4. |
| Label | URL |
|---|---|
| A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS) | View source |
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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 and approval of the indication studied in the US and European Union (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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/0.75 Milligram (mg) Dulaglutide | Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the open Label Extension (OLE). |
| FG001 | 0.75 mg Dulaglutide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2020 | Apr 11, 2022 |
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| Placebo | Drug | Administered SC |
|
| Baseline, Week 26 |
| Change From Baseline in Fasting Blood Glucose (FBG) at Week 26 | Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group [ less than (<) 8%, greater than or equal to (>=) 8%).](streamdown:incomplete-link) | Baseline, Week 26 |
| Percentage of Participants With HbA1c ≤7.0% | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. | Week 26 |
| Change From Baseline in Body Mass Index (BMI) at Week 26 | BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (< 8%, >= 8%). | Baseline, Week 26 |
| Percentage of Participants With Self-Reported Events of Hypoglycemia | Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose <54mg/dL. | Week 26 |
| Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia | Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized. | Week 26 |
| Number of Participants With Adjudicated Pancreatitis | The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Week 26 |
| Change From Baseline in Pancreatic Enzymes at Week 26 | Serum Amylase (total and pancreas-derived) and lipase concentrations were measured. | Baseline, Week 26 |
| Number of Participants With Thyroid Treatment-Emergent Adverse Events | Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized. | Week 26 |
| Change From Baseline in Serum Calcitonin at Week 26 | Change from Baseline in Serum Calcitonin was evaluated. | Baseline, Week 26 |
| Percentage of Participants With Allergic, Hypersensitivity Reactions | The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Week 26 |
| Percentage of Participants With Injection Site Reactions | The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Week 26 |
| Number of Participants With Anti-Dulaglutide Antibodies | Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. | Baseline through Week 56 |
| Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss) | PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9. | Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit |
| PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss] | PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9. | Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Advanced Research Center | Anaheim | California | 92805 | United States |
| Division of Endocrinology, Diabetes, and Metabolism | Los Angeles | California | 90027 | United States |
| Childrens Hospital of Orange County | Orange | California | 92868 | United States |
| Center of Excellence in Diabetes & Endocrinology | Sacramento | California | 95821 | United States |
| Rady Childrens Hospital - San Diego | San Diego | California | 92123 | United States |
| JC Cabaccan | San Jose | California | 95148 | United States |
| Touro University | Vallejo | California | 94592 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Florida Center for Endocrinology & Metabolism | Orlando | Florida | 32803 | United States |
| St. Luke's Regional Medical Center | Boise | Idaho | 83712 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808-4124 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| ECU Pediatric Specialty Care | Greenville | North Carolina | 27834 | United States |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Seattle Children's Hospital Research Foundation | Seattle | Washington | 98105 | United States |
| Multicare Health System | Tacoma | Washington | 98405 | United States |
| CAMC Institute | Charleston | West Virginia | 25302 | United States |
| Instituto Estadual de Diabetes e Endocrinologia | Rio de Janeiro | Rio de Janeiro | 20211-340 | Brazil |
| Centro de Pesquisas em Diabetes | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Instituto da Criança com Diabetes | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Hospital PUC-CAMPINAS | Campinas | São Paulo | 13034-685 | Brazil |
| Hospital das Clinicas da FMRP | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| CPCLIN | São Paulo | São Paulo | 01228-200 | Brazil |
| Hospital da Clinicas da Faculdade de Medicina da USP | São Paulo | São Paulo | 05403-000 | Brazil |
| UNIFESP - Escola Paulista de Medicina | São Paulo | 04022-001 | Brazil |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| Hopital Robert Debre | Paris | 75019 | France |
| Praxis Dr. med. Landers | Mayen | Rhineland-Palatinate | 56727 | Germany |
| Zentrum für klinische Studien | Sankt Ingbert | Saarland | 66386 | Germany |
| RED-Institut GmbH | Oldenburg in Holstein | Schleswig-Holstein | 23758 | Germany |
| Heim Pal Gyermekkorhaz | Budapest | 1089 | Hungary |
| Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre | Ahmedabad | Gujarat | 380007 | India |
| Manipal Hospital | Bangalore | Karmnataka | 560017 | India |
| M S Ramaiah Medical College Hospital | Bangalore | Karnataka | 560054 | India |
| Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | 411004 | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Post Graduate Institute of Medical Education & Research | Chandigarh | Punjab | 160012 | India |
| Banaras Hindu University - BHU | Varanasi | Uttar Pradesh | 221005 | India |
| Park Clinic | Kolkata | West Bengal | 700017 | India |
| Apollo Gleneagles Hospitals Kolkata | Kolkata | West Bengal | 700054 | India |
| Health Pharma Professional Research, S.A. de C.V. | Mexico City | Federal District | 03810 | Mexico |
| Centro de Inv. Medica de Occidente, SC | Zapopan | Jalisco | 45116 | Mexico |
| Centro Medico San Francisco | Monterrey | Nuevo León | 64710 | Mexico |
| Cli-nica Hospital Cemain | Tampico | Tamaulipas | 89249 | Mexico |
| Hospital Angeles Puebla | Puebla City | 72190 | Mexico |
| Arke Estudios Clinicos S.A. de C.V. | Veracruz | 91910 | Mexico |
| Centro de Diabetes y Endocrinologia Pediatrica de PR | Bayamón | PR | 00959 | Puerto Rico |
| King Saud University Hospital | Riyadh | 11472 | Saudi Arabia |
| King Salman bin Abdulaziz Hospital - Diabetic Center | Riyadh | 12769 | Saudi Arabia |
| Ankara University Medicine Hospital | Ankara | Mamak | 06100 | Turkey (Türkiye) |
| Sami Ulus Education & Research Hospital | Ankara | 06080 | Turkey (Türkiye) |
| Duzce University Medical Faculty | Düzce | 81620 | Turkey (Türkiye) |
| Ondokuz Mayis University Medical Faculty | Samsun | 55139 | Turkey (Türkiye) |
| Alder Hey Children's Hospital | Liverpool | Lancashire | L14 5AB | United Kingdom |
| St James's University Hospital | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE. |
| FG002 | 1.5 mg Dulaglutide | Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open Label Extension (OLE) |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/0.75 mg Dulaglutide | Participants received placebo administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the OLE. |
| BG001 | 0.75 mg Dulaglutide | Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE. |
| BG002 | 1.5 mg Dulaglutide | Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Percentage of Hemoglobin A1c (HbA1c) at Baseline | Mean | Standard Deviation | Percentage of HbA1c |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline). | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c. | Posted | Least Squares Mean | Standard Error | percentage of HbA1C | Baseline, Week 26 |
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| Secondary | Change From Baseline in HbA1c (Individual Doses) at Week 26 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline). | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 26 |
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| Secondary | Change From Baseline in Fasting Blood Glucose (FBG) at Week 26 | Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group [ less than (<) 8%, greater than or equal to (>=) 8%).](streamdown:incomplete-link) | All randomized participants who received at least one dose of study drug and had evaluable fasting blood glucose data. Only pre-rescue measurements were used. | Posted | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | Baseline, Week 26 |
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| Secondary | Percentage of Participants With HbA1c ≤7.0% | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. | All randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline HbA1c. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Change From Baseline in Body Mass Index (BMI) at Week 26 | BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (< 8%, >= 8%). | All randomized participants who received at least one dose of study drug and had evaluable BMI data. | Posted | Least Squares Mean | Standard Error | kilograms/square meter (kg/m^2) | Baseline, Week 26 |
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| Secondary | Percentage of Participants With Self-Reported Events of Hypoglycemia | Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose <54mg/dL. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia | Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Number of Participants With Adjudicated Pancreatitis | The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Week 26 |
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| Secondary | Change From Baseline in Pancreatic Enzymes at Week 26 | Serum Amylase (total and pancreas-derived) and lipase concentrations were measured. | All randomized participants who received at least one dose of study drug and had evaluable pancreatic enzymes data. | Posted | Mean | Standard Deviation | Units/Liter (U/L) | Baseline, Week 26 |
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| Secondary | Number of Participants With Thyroid Treatment-Emergent Adverse Events | Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized. | All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Week 26 |
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| Secondary | Change From Baseline in Serum Calcitonin at Week 26 | Change from Baseline in Serum Calcitonin was evaluated. | All randomized participants who received at least one dose of study drug and had evaluable serum calcitonin data. | Posted | Mean | Standard Deviation | nanograms per liter (ng/L) | Baseline, Week 26 |
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| Secondary | Percentage of Participants With Allergic, Hypersensitivity Reactions | The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants With Injection Site Reactions | The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Number of Participants With Anti-Dulaglutide Antibodies | Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. | All randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result. | Posted | Number | participants | Baseline through Week 56 |
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| Secondary | Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss) | PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | 95% Confidence Interval | nanograms per milliliter (ng/mL) | Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss] | PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | 95% Confidence Interval | nanogram*hour per milliliter (ng*h/ mL) | Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit |
|
|
Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo: Double-Blind Period | Participants received placebo administered SC for 26 weeks. | 0 | 51 | 3 | 51 | 26 | 51 |
| EG001 | 0.75 mg Dulaglutide: Double-Blind Period | Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks. | 0 | 51 | 1 | 51 | 25 | 51 |
| EG002 | 1.5 mg Dulaglutide: Double-Blind Period | Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks. | 0 | 52 | 1 | 52 | 28 | 52 |
| EG003 | Placebo/0.75 mg Dulaglutide: Open Label Extension (OLE) | Participants who had received placebo during the double-blind period were given 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period. | 0 | 47 | 0 | 47 | 18 | 47 |
| EG004 | 0.75 mg Dulaglutide: OLE | Participants received 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period. | 0 | 49 | 1 | 49 | 16 | 49 |
| EG005 | 1.5 mg Dulaglutide: OLE | Participants received 1.5 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period. | 0 | 50 | 2 | 50 | 20 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right ventricular failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nonalcoholic fatty liver disease | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2021 | Apr 11, 2022 | SAP_001.pdf |
| 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
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| France |
|
| Germany |
|
| India |
|
| Mexico |
|
| Puerto Rico |
|
| Saudi Arabia |
|
| Turkey |
|
| United Kingdom |
|
| United States |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| OG003 | Pooled Dulaglutide | Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks. |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|