| Outcome Measures: |
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)., Baseline, Week 26 | 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)., 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%)., 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
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| Locations: |
University of Alabama Birmingham, Birmingham, Alabama, 35233, United States|University of Arizona, 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, 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|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|Instituto Estadual de Diabetes e Endocrinologia, Rio de Janeiro, RJ, 20211-340, Brazil|Hospital PUC-CAMPINAS, Campinas, Sao Paulo, 13034-685, Brazil|CPCLIN, São Paulo, SP, 01228-200, Brazil|Hospital da Clinicas da Faculdade de Medicina da USP, São Paulo, SP, 05403-000, Brazil|Hospital das Clinicas da FMRP, Ribeirão Preto, São Paulo, 14051-140, Brazil|UNIFESP - Escola Paulista de Medicina, São Paulo, 04022-001, Brazil|Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre, Le Kremlin Bicetre, 94275, France|Hopital Robert Debre, Paris, 75019, France|Praxis Dr. med. Landers, Mayen, Rheinland-Pfalz, 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|Sir Ganga Ram Hospital, New Delhi, Delhi, 110060, India|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|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 Leon, 64710, Mexico|Cli-nica Hospital Cemain, Tampico, Tamaulipas, 89249, Mexico|Hospital Angeles Puebla, Puebla, 72190, Mexico|Arke Estudios Clinicos S.A. de C.V., Veracruz, 91910, Mexico|Centro de Diabetes y Endocrinologia Pediatrica de PR, Bayamon, 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|Sami Ulus Education & Research Hospital, Ankara, 06080, Turkey|Duzce University Medical Faculty, Duzce, 81620, Turkey|Ondokuz Mayis University Medical Faculty, Samsun, 55139, Turkey|Alder Hey Children's Hospital, Liverpool, Lancashire, L14 5AB, United Kingdom|St James's University Hospital, Leeds, West Yorkshire, LS9 7TF, United Kingdom
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