chufangao/CTO huggingface dataset:
Clinical trial NCT04437368: EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
Official title: EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Acronym: EXPLORE
Sponsor: Gyroscope Therapeutics Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.
Enrollment: 98.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-07-14
Primary completion date: 2024-04-05
Completion date: 2024-04-05
Clinical trial NCT04382755: Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure
Official title: A Prospective Randomized Open-label Interventional Study to Investigate the Efficacy of Complement C5 Inhibition With Zilucoplan® in Improving Oxygenation and Short-and Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure
Acronym: ZILU-COV
Sponsor: University Hospital, Ghent (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 81.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-22
Primary completion date: 2020-12-29
Completion date: 2021-04-09
Plan to share individual participant data: NO
Clinical trial NCT02411786: A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF
Official title: A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD), With or Without Granulocyte Macrophage Colony-Stimulating Factor Adjuvant, in Patients With Metastatic Prostate Cancer
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-08-24
Primary completion date: 2019-05-01
Completion date: 2020-11-28
Clinical trial NCT02597153: Phase II Clinical Study of PLM60 for the Treatment of Cutaneous T Cell Lymphomas
Official title: A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Cutaneous T Cell Lymphomas
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Just one subject enrolled in this trial during one and a half years.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-10-31
Primary completion date: 2017-10-31
Completion date: 2020-10-31
Clinical trial NCT03652974: Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
Official title: Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
Sponsor: Shanghai Mental Health Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 145.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-09-06
Primary completion date: 2021-08-30
Completion date: 2021-08-30
Plan to share individual participant data: NO
Clinical trial NCT03861988: Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Official title: Double-blind Trial of Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-08-22
Primary completion date: 2022-09-22
Completion date: 2022-09-27
Plan to share individual participant data: NO
IPD sharing description: No current plan to share data.
Clinical trial NCT03371173: ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)
Official title: A Pilot Study to Explore Preliminary Safety, Tolerability and Efficacy of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Pulmonary Hypertension and Iron Deficiency Anemia
Acronym: ORION-PH-1
Sponsor: Hannover Medical School (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-27
Primary completion date: 2020-03-19
Completion date: 2020-03-19
Clinical trial NCT03187691: Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia
Official title: An Open Label Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous (AML) and Lymphoblastic Leukaemia (ALL)
Sponsor: Matinas BioPharma Nanotechnologies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Protocol redundancy
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-08-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT05540665: Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy and Safety of Daxdilimab in Adult Participants With Active Proliferative Lupus Nephritis
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 19.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-04-26
Primary completion date: 2024-01-04
Completion date: 2024-01-04
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT04679350: Efficacy and Safety of hzVSFv13 in Patients With COVID-19 Pneumonia
Official title: A Multi Center, Randomized, Double-blind, Parallel Design, Phase 2 Study to Evaluate the Efficacy and Safety of hzVSFv13 Compared to Standard of Care After Intravenous(IV) Administration With Add-on Standard of Care in COVID-19 Moderate to Severe Patients
Sponsor: ImmuneMed, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A new study combining Phase III clinical trials has been planned.
Enrollment: 1.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-03-18
Primary completion date: 2022-11-30
Completion date: 2022-12-30
Plan to share individual participant data: NO
Clinical trial NCT03401229: Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis
Acronym: OSTRO
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 413.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-15
Primary completion date: 2020-07-31
Completion date: 2020-07-31
Baseline population: Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment.
Limitations and caveats: During COVID-19 pandemic, for ongoing patients, patient dosing, scheduled visits, and nasal endoscopies are inevitable impacted. Week 40 was made as the primary timepoint to mitigate the impact of COVID disruptions on the primary endpoint.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03222089: Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC
Official title: FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer: a Phase II Trial by the FNF Team.
Sponsor: Fujian Cancer Hospital (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Another study enrolling the similar group of patient are ongoing
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-20
Primary completion date: 2019-07-20
Completion date: 2020-07-20
Plan to share individual participant data: NO
Clinical trial NCT04092179: Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers
Official title: Phase Ib/II Study of IDH2 Inhibitor Enasidenib in Combination With BCL2 Inhibitor Venetoclax in Patients With IDH2-Mutated Myeloid Malignancies (ENAVEN-AML)
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Insufficient Funding
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-05
Primary completion date: 2023-10-26
Completion date: 2023-10-26
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04189263: BREADS: Breast Adjuvant Diet Study
Official title: IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low participant compliance, slow recruitment
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-04
Primary completion date: 2023-03-30
Completion date: 2023-03-30
Plan to share individual participant data: NO
Clinical trial NCT04843722: COVID-19 Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines
Official title: Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use
Sponsor: ImmunityBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The sponsor has changed the development plans which is not for safety reasons.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-31
Primary completion date: 2022-03-31
Completion date: 2022-08-31
Plan to share individual participant data: NO
Clinical trial NCT04589949: Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study)
Official title: Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study)
Acronym: CoV-Early
Sponsor: Erasmus Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: vaccination uptake 80% in the target population/new COVID variant
Enrollment: 420.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-12
Primary completion date: 2021-10-01
Completion date: 2022-03-01
Clinical trial NCT04006925: Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
Official title: Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-10
Primary completion date: 2022-02-01
Completion date: 2022-02-01
Plan to share individual participant data: NO
Clinical trial NCT05022303: AT1001 for the Treatment of COVID-19 Related MIS-C
Official title: A Phase 2a (Proof of Concept), Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AT1001 for the Treatment of COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C)
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Decline in MISC cases
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-01
Primary completion date: 2024-05-15
Completion date: 2024-05-15
Plan to share individual participant data: NO
Clinical trial NCT04167995: Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder
Official title: Assessment of Probiotic Strain Lactobacillus Acidophilus LB Supplementation as Adjunctive Management of Attention-deficit Hyperactivity Disorder in Children and Adolescents: a Randomized Controlled Clinical Trial
Acronym: ADHD
Sponsor: Ain Shams University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-09
Primary completion date: 2020-11-09
Completion date: 2021-10-30
Plan to share individual participant data: NO
Clinical trial NCT03526874: Occipital Blocks for Acute Migraine
Official title: Occipital Nerve Blocks for Acute Treatment of Pediatric Migraine
Sponsor: Children's Hospital of Philadelphia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 63.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-03
Primary completion date: 2023-03-10
Completion date: 2023-03-10
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03944473: Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
Official title: Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries
Acronym: Sugammadex
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Stopped before IRB approval
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-20
Primary completion date: 2020-07-20
Completion date: 2020-07-20
Plan to share individual participant data: NO
Clinical trial NCT03589794: rCSP/AP10-602 [GLA-LSQ] Vaccine Trial
Official title: A Phase I Challenge Study to Evaluate Safety, Immunogenicity, and Efficacy of a Malaria Vaccine (rCSP Adjuvanted With AP 10-602 [GLA-LSQ]), in Healthy Adults
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 65.0 (ACTUAL)
Number of arms: 7.0
Start date: 2018-12-21
Primary completion date: 2022-07-05
Completion date: 2022-07-05
Clinical trial NCT03283150: Deep Brain Stimulation (DBS) Sedation
Official title: Effects of Anesthesia Drugs on Neuronal Activity in the Basal Ganglia and Thalamus During Deep Brain Stimulation Electrode Implantation Surgery
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to a decrease in scheduled study-eligible patients, we terminated the study prematurely
Enrollment: 20.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-12-01
Primary completion date: 2022-01-20
Completion date: 2022-01-20
Baseline population: No subjects were accrued to the baseline propofol and dexmedetomidine groups. The study was stopped early due to COVID decreasing participant flow and the frequency of the surgery dropping due to surgeon loss.
Clinical trial NCT03315130: Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia Gravis
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-10-11
Primary completion date: 2018-12-10
Completion date: 2020-11-19
Baseline population: Intent-to-Treat (ITT) population included all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT05349617: Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years
Official title: A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age
Sponsor: Bavarian Nordic (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 413.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-12
Primary completion date: 2023-06-19
Completion date: 2023-08-08
Clinical trial NCT06048770: A Study of RBI-4000 in Healthy Participants
Official title: A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of RBI-4000 in Healthy Volunteers
Sponsor: Replicate Bioscience (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic business decision (not related to safety, efficacy, or quality)
Enrollment: 89.0 (ACTUAL)
Number of arms: 5.0
Start date: 2023-09-01
Primary completion date: 2024-07-31
Completion date: 2024-07-31
Plan to share individual participant data: NO
Clinical trial NCT04039477: A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP
Official title: A Phase 2 Randomized, Dose-blind, Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP)
Acronym: MARINA
Sponsor: Kezar Life Sciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Clinical trial activity slowdown due to COVID-19 pandemic, high screen fail rate, and lack of enrollment led to the decision to withdraw the MARINA study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-31
Primary completion date: 2020-08-05
Completion date: 2020-08-05
Plan to share individual participant data: NO
Clinical trial NCT05096208: Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN HEALTHY ADULTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1028.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-21
Primary completion date: 2022-04-04
Completion date: 2022-04-04
Baseline population: Safety population included all randomized participants who received study intervention.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05517837: A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants
Official title: A Phase 1, Randomized, Multi-Part, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986421 in Healthy Participants
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Adverse change in the risk/benefit.
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-13
Primary completion date: 2023-07-14
Completion date: 2023-07-14
Plan to share individual participant data: NO
IPD sharing description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Clinical trial NCT04795531: A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)
Official title: A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.
Acronym: ONWARDS 3
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 588.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-24
Primary completion date: 2022-06-23
Completion date: 2022-06-23
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com