| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26, Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Week 26 relative to Baseline. Mixed model for repeated measures (MMRM) was used for the analysis., Baseline and Week 26 | Secondary: Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52, Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Weeks 12, 18, 39 and 52 relative to Baseline. MMRM was used for the analysis., Baseline and Weeks 12, 18, 39 and 52|Percentage of Participants With Clinically Significant Physical Examination Findings, Physical examination included examination of the following body systems: (1) respiratory system; (2) cardiovascular system; (3) nervous system (4) dermatologic system; and (5) gastrointestinal system. A summarized data for the above body systems was reported for participants with clinically significant findings., From Day 1 to end of treatment period (up to 52 weeks)|Percentage of Participants With Abnormal Vital Signs Values, Vital signs included body temperature (oral or tympanic measurement), respiratory rate, blood pressure \[systolic blood pressure (SBP) and diastolic blood pressure (DBP)\] resting more than 5 minutes, and pulse (beats per minute). Data for participants with abnormal vital signs was reported. The percentage of participants are calculated based on the participants with non-missing data at that time-point., From Day 1 to end of treatment period (up to 52 weeks)|Percentage of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings, Week 26 and 52|Percentage of Participants With Treatment-emergent Adverse Events (TEAE), An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment., From the study start up to end of the study (up to 54 weeks)|Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions, The percentage of participants are calculated based on the participants with non-missing data at that time-point., From Day 1 to end of treatment period (up to 52 weeks)|Percentage of Participants With Hypoglycemia, Mild to moderate hypoglycemia (abnormal low blood sugar) was defined as blood glucose less than (\<) 60 milligram per deciliter (mg/dL) (3.33 millimole per liter \[mmol/L\]) in the presence of symptoms, or blood glucose \<50 mg/dL (2.78 mmol/L) with or without symptoms. Severe hypoglycemia was defined as any episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, associated with a documented blood glucose \<60 mg/dL (3.33 mmol/L) (unless the clinical situation makes obtaining a blood glucose difficult \[example, it involves coma or seizure\])., From Day 1 to end of treatment period (up to 52 weeks)|Percentage of Participants With Abnormal Safety Laboratory Findings, The percentage of participants with any abnormal standard safety laboratory values (hematology, serum chemistry, and urinalysis) were collected throughout study. Abnormal values for hematology included hematocrit (percentage of hematocrit \[%\]), hemoglobin (grams per liter \[g/L\]), erythrocyte mean corpuscular volume (MCV)(femtoliter \[fL\]), erythrocytes (10\^12/L), and leukocytes (10\^9/L). Abnormal values for serum chemistry included for alanine aminotransferase (units per liter \[U/L\]), aspartate aminotransferase (U/L), cholesterol (millimoles per liter \[mmol/L\]), gamma glutamyl transferase (U/L), glucose (mmol/L): \< 2.8 mmol/L, potassium (mmol/L), sodium (mmol/L), and triglycerides (mmol/L). ULN is upper limit of normal and LLN is lower limit of normal., From Day 1 to end of treatment period (up to 52 weeks)|Change From Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52, Biomarkers of bone turnover are bone-specific alkaline phosphatase to assess changes in bone formation and C-terminal telopeptide (CTX) to assess changes in bone resorption., Baseline, Weeks 26 and 52|Change From Baseline in CD26 (CD4+T Cells) Surface Antigen Levels at Weeks 26 and 52, Baseline, Weeks 26 and 52|Change From Baseline in CD26 (CD8+T Cells) Surface Antigen Levels at Weeks 26 and 52, Baseline, Weeks 26 and 52
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| Locations: |
Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, 72202, United States|Children's Hospital Los Angeles, Los Angeles, California, 90027, United States|Sherif Khamis, Palmdale, California, 93550, United States|Lucile Packard Children's Hospital at Stanford University, Palo Alto, California, 94304, United States|Touro University California, Vallejo, California, 94592, United States|Yale New Haven Hospital, New Haven, Connecticut, 06511, United States|Children's National Health System, Washington, District of Columbia, 20010, United States|University of Florida, Gainesville, Florida, 32610, United States|Nemours Childrens Specialty Care - Jacksonville, Jacksonville, Florida, 32207, United States|Baptist Diabetes Associates Research, Miami, Florida, 33156, United States|University of South Florida/USF Health, Tampa, Florida, 33612, United States|Endocrine Consultants Research, Columbus, Georgia, 31904, United States|Endocrine Consultants Research - Oak Hill Court, Newnan, Georgia, 30265, United States|Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, 60611, United States|Indiana University, Indianapolis, Indiana, 46202, United States|University of Iowa, Iowa City, Iowa, 52242, United States|University of Kentucky Health Care, Lexington, Kentucky, 40504, United States|Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States|Ochsner Baptist Medical Center, New Orleans, Louisiana, 70115, United States|University of Minnesota Masonic Children's Hospital - Pediatric Specialty Care Discovery Clinic, Minneapolis, Minnesota, 55454, United States|Gulfside Clinical Research, Gulfport, Mississippi, 39501, United States|Saint Louis University, Saint Louis, Missouri, 63104, United States|Horizon View Medical Center, Las Vegas, Nevada, 89149, United States|Saint Joseph's Regional Medical Center - Paterson, Paterson, New Jersey, 07503, United States|University of Rochester, Rochester, New York, 14642, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Greenville Health System - Patewood, Greenville, South Carolina, 29615, United States|Monument Health Clinical Research, Rapid City, South Dakota, 57701, United States|UT Le Bonheur Pediatric Specialists, Memphis, Tennessee, 38105, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75235, United States|Baylor College of Medicine Advanced Liver Therapies, Houston, Texas, 77030, United States|University of Virginia, Charlottesville, Virginia, 22908, United States|Seattle Children's Hospital, Seattle, Washington, 98003, United States|Multicare Health System Institute for Research and Innovation, Tacoma, Washington, 98405, United States|Instituto de Estudos e Pesquisas Clinicas do Ceara, Fortaleza, Ceara, 60160-230, Brazil|Hospital Universitario Joao de Barros Barreto, Belem, Para, 66073-005, Brazil|Instituto da Crianca com Diabetes, Porto Alegre, RIO Grande DO SUL, 91350-250, Brazil|Hospital Sirio Libanes, Sao Paulo, 01308-050, Brazil|The Chaim Sheba Medical Center, Ramat Gan, Tel Aviv, 52621, Israel|Hadassah University Hospital Mount Scopus, Jerusalem, 9765422, Israel|Clalit Medical Center, Tel Aviv, 6203854, Israel|Ospedale Policlinico SS Annunziata, Chieti, 66100, Italy|Azienda Ospedaliera Universitaria Federico II, Napoli, 80131, Italy|Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, Italy|Ospedale Pediatrico Bambino Gesu, Roma, 146, Italy|Centro de Atencion e Investigacion en Factores de Riesgo Cardiovascular Omega (Clinica Omega), Ciudad de Mexico, Distrito Federal, 6700, Mexico|Instituto Nacional de Pediatria, Mexico, Distrito Federal, 14530, Mexico|Mentrials, SA de CV, Mexico, Distrito Federal, 6400, Mexico|Endo Clinic, Guadalajara, Jalisco, 44130, Mexico|Desarrollo Etico en Investigacion Clinica, Guadalajara, Jalisco, 44500, Mexico|Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V., Zapopan, Jalisco, 45030, Mexico|IECSI-Centro Medico y de Investigacion Clinica, Monterrey, Nuevo LEON, 64310, Mexico|Centro Integral Medico Sjr, San Juan del Rio, Queretaro, 76800, Mexico|Ono Consultoria Medica Integral, Aguascalientes, 20129, Mexico|Centro de Investigacion Cardiometabolica de Aguascalientes, Aguascalientes, Mexico|EL CIELO Medical Center, Puebla, 72160, Mexico|Specjalistyczna Praktyka Lekarska ASPIRO, Wroclaw, Dolnoslaskie, 50-341, Poland|Twoja Przychodnia - Centrum Medyczne Nowa Sol, Nowa Sol, Lubuskie, 67-100, Poland|Holmed, Warszawa, Mazowieckie, 01-494, Poland|MedPolonia, Poznan, Wielkopolskie, 60-693, Poland|Sonomed, Szczecin, Zachodniopomorskie, 71-685, Poland|Saint Petersburg State Pediatric Medical Academy, Saint-Petersburg, Saint Petersburg, 194100, Russian Federation|Republican Children's Clinical Hospital-Izhevsk, Izhevsk, Udmurtia, 426009, Russian Federation|Kuzbass Regional Clinical Hospital n.a. S.V. Belyaev, Kemerovo, 650066, Russian Federation|Novosibirsk State Medical University, Novosibirsk, 630087, Russian Federation|Omsk Regional Children's Hospital, Omsk, 644001, Russian Federation|Siberian State Medical University, Tomsk, 634050, Russian Federation
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