chufangao/CTO huggingface dataset:
Clinical trial NCT04399551: A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
Official title: A Phase IIIb, Open-label, Hybrid Type III Trial Evaluating Implementation Strategies for Long-acting Cabotegravir Plus Long-acting Rilpivirine Every Two Months in HIV-1 Infected, Virologically Suppressed Adults in Select European Healthcare Settings
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 437.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-28
Primary completion date: 2022-03-07
Completion date: 2023-03-13
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT05787028: Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
Official title: Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
Acronym: AD16
Sponsor: South China Center For Innovative Pharmaceuticals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-30
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Clinical trial NCT04279938: A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL
Official title: A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL - REACH
Sponsor: Royal Marsden NHS Foundation Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Safety data on drug
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-30
Primary completion date: 2020-03-31
Completion date: 2021-01-31
Plan to share individual participant data: NO
Clinical trial NCT04139057: EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC
Official title: Single-Arm Trial of EBV-Specific TCR-T Cells With Anti-PD1 Auto-secreted Element in the Treatment of EBV-Positive Head and Neck Carcinoma
Sponsor: Xinqiao Hospital of Chongqing (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Scheduled Pause
Enrollment: 18.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2019-03-01
Primary completion date: 2024-12-01
Completion date: 2024-12-01
Plan to share individual participant data: NO
Clinical trial NCT04025177: Indomethacin PK-PD in Extremely Preterm Neonates
Official title: Pharmacokinetics and Pharmacodynamics of Indomethacin Used for PDA Treatment in Extremely Preterm Neonates <27 Weeks Gestational Age
Acronym: INDO
Sponsor: University of Manitoba (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Halted due to feasibility issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-31
Primary completion date: 2021-08-31
Completion date: 2022-02-28
Plan to share individual participant data: NO
Clinical trial NCT04399356: Niclosamide for Mild to Moderate COVID-19
Official title: Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Sponsor: Tufts Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 73.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2021-04-20
Completion date: 2021-08-19
Limitations and caveats: There was a precipitous and persistent decrease in the rate of COVID-19 diagnoses in spring and summer 2021 that decreased our enrollment pool. Additionally, as vaccination rates rose, our predetermined exclusion criteria of individuals vaccinated against SARS-CoV-2 limited those available for enrollment.
Clinical trial NCT05170789: Elotuzumab, Selinexor, and Dexamethasone for Relapsed Refractory Multiple Myeloma
Official title: A Phase II, Single-Arm, Study of Elotuzumab, Selinexor, and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma
Acronym: ESdRRMM
Sponsor: Tulane University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study collaborator -Karyopharm- is not doing Myeloma studies funding, so they let the study investigators know they are not funding the study anymore.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-04-27
Primary completion date: 2022-04-27
Completion date: 2022-04-27
Plan to share individual participant data: NO
Clinical trial NCT04614142: Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access
Official title: Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Single patient the protocol was written for consented to another study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-13
Primary completion date: 2021-08-04
Completion date: 2021-08-04
Plan to share individual participant data: NO
IPD sharing description: Data will not be shared outside of the research team.
Clinical trial NCT05920408: Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours
Official title: A Phase 1B/2A Study to Assess the Safety, Tolerability, Pharmacokinetic and Anti-tumoral Activity of EXS21546 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours
Sponsor: Exscientia AI Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Emerging data demonstrates challenge for EXS21546 to reach suitable therapeutic index.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-04-11
Primary completion date: 2023-09-27
Completion date: 2023-10-23
Plan to share individual participant data: NO
Clinical trial NCT04450394: A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Official title: A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 278.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-01
Primary completion date: 2021-10-08
Completion date: 2021-10-08
Baseline population: All randomized participants.
Limitations and caveats: The study was initially designed as 3 arms: LY3209590 Algorithm 1 (Paper), LY3209590 Algorithm 2 (Digital), and Insulin Degludec. However, it was amended to terminate the LY3209590 Algorithm 2 (Digital) arm during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses, but safety data was analysed and reported.
Plan to share individual participant data: YES
IPD sharing description: 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.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03826199: Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
Official title: Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)
Acronym: PrEP-PP
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Start date: 2019-08-23
Primary completion date: 2021-12-01
Completion date: 2023-09-30
Baseline population: 200 pregnant women enrolled in formative study and followed for 12 months postpartum
Clinical trial NCT03544099: Pembrolizumab for Nasopharyngeal Carcinoma Patients With Detectable Plasma Epstein-Barr Virus DNA
Official title: Pembrolizumab for Nasopharyngeal Carcinoma Patients With Detectable Plasma Epstein-Barr Virus DNA But Without Clinically Detectable Residual Diseases and/or Metastases After Curative Chemoradiation - A Single Arm Phase II Trial
Sponsor: National Health Research Institutes, Taiwan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Difficult to recruit Nasopharyngeal Carcinoma Patients With Detectable Plasma Epstein-Barr Virus DNA
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-07
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT03762447: A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
Official title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 138.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-10
Primary completion date: 2023-11-17
Completion date: 2023-11-17
Plan to share individual participant data: NO
Clinical trial NCT02520427: A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
Official title: A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Amgen strategic business decision to cancel following portfolio review, re-prioritization.
Enrollment: 95.0 (ACTUAL)
Number of arms: 5.0
Start date: 2015-08-31
Primary completion date: 2022-01-09
Completion date: 2022-01-09
Limitations and caveats: Group 5 dose-escalation cohort and dose-expansion cohorts were not enrolled in the study, due to the study terminating early.
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 NCT03826628: Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
Official title: A Phase 2/3, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Response Comparison of the Efficacy and Safety of a Topical Rapamycin Cream for the Treatment of Facial Angiofibromas (FA) Associated With Tuberous Sclerosis Complex (TSC) in Patients 6 Years of Age and Over
Sponsor: Dermatology Specialties Limited Partnership (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 107.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-28
Primary completion date: 2022-09-01
Completion date: 2022-09-01
Limitations and caveats: Covid-19 pandemic halted recruitment, leading to a smaller number of patients recruited than intended (107/120).
Plan to share individual participant data: NO
IPD sharing description: Individual Participant Data is not planned to be shared with other researchers
Clinical trial NCT02976701: Effect of DLBS1033 After Primary PCI in Patients With STE-ACS
Official title: The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention
Sponsor: Dexa Medica Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The investigational cases were no longer relevant considering the recent implementation of our current national healthcare system.
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2023-01-31
Completion date: 2023-03-31
Clinical trial NCT05205161: A Phase I/II Study of AZD0466 as Monotherapy or in Combination With Anticancer Agents in Advanced Non-Hodgkin Lymphoma
Official title: A Modular Phase I/II, Open-label, Dose Escalation and Expansion, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0466 as Monotherapy or in Combination With Anticancer Agents in Patients With Advanced Non-Hodgkin Lymphoma.
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to safety reasons.
Enrollment: 7.0 (ACTUAL)
Number of arms: 8.0
Start date: 2022-07-05
Primary completion date: 2023-08-17
Completion date: 2023-08-17
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 requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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 refer 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 patientlevel 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 NCT03689244: A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study With Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an add-on to Standard of Care Therapy in Subjects With Inoperable or Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension
Acronym: SELECT
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study did not demonstrate efficacy on the primary endpoint, PVR vs. placebo at wk 20 at a planned interim analysis.
Enrollment: 128.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-01-23
Primary completion date: 2022-06-07
Completion date: 2022-06-07
Limitations and caveats: Failure to meet success on the primary outcome measure led to termination of the study for futility and thus the pre-planned testing hierarchy was no longer applicable, and all efficacy analyses other than the primary endpoint (PVR) were exploratory.
Plan to share individual participant data: YES
IPD sharing description: Actelion is a Janssen pharmaceutical company of Johnson \& Johnson. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency.~As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT03263767: Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC
Official title: Phase II Study Testing Prophylaxis Feasibility of Graft Versus Host Disease With Only High Dose Cyclophosphamide Post-transplantation for Patients Eligible to a Reduced-intensity Conditioning Regiment Prior to Allogenic Transplantation With a Compatible Familial or Non-familial Donor.
Acronym: CYRIC
Sponsor: Nantes University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Security criteria (MTD)
Enrollment: 47.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-15
Primary completion date: 2021-10-21
Completion date: 2022-06-21
Plan to share individual participant data: NO
Clinical trial NCT04579133: Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy
Official title: Phase II Randomized Study of Neoadjuvant Durvalumab (MEDI4736) Alone Versus Durvalumab (MEDI4736) With Olaparib (AZD2281) in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy
Sponsor: Latin American Cooperative Oncology Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Not approved
Enrollment: 140.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-01
Primary completion date: 2021-03-01
Completion date: 2021-03-01
Clinical trial NCT04017832: A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes
Official title: China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
Acronym: PIONEER 12
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1441.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-29
Primary completion date: 2021-10-27
Completion date: 2021-10-27
Baseline population: Full analysis set (FAS) included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04086212: Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
Official title: Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.
Sponsor: Iperboreal Pharma Srl (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study never started
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-02
Primary completion date: 2022-12-31
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT02625610: Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
Official title: A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 499.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-24
Primary completion date: 2019-09-13
Completion date: 2021-06-03
Baseline population: Full analysis set included all randomized participants included in treatment arm to which they were randomized.
Clinical trial NCT04869943: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer
Official title: Randomized Crossover Ph3 to Evaluate Efficacy/Safety of Enobosarm Monotherapy vs Active Control for Treatment of AR+/ER+/HER2- MBC With AR Staining Previously Treated w/Nonsteroidal Aromatase Inhibitor, SERD & CDK 4/6 Inhibitor
Acronym: ARTEST
Sponsor: Veru Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-12
Primary completion date: 2024-01-09
Completion date: 2024-01-09
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03274804: Combined PD-1 and CCR5 Inhibition for the Treatment of Refractory Microsatellite Stable mCRC
Official title: A Phase I Trial of Combined PD-1 Inhibition (Pembrolizumab) and CCR5 Inhibition (Maraviroc) for the Treatment of Refractory Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)
Acronym: PICCASSO
Sponsor: University Hospital Heidelberg (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-01
Primary completion date: 2020-03-01
Completion date: 2020-03-01
Baseline population: The required parameters as defined in the inclusion and exclusion criteria are met by all patients.
Plan to share individual participant data: NO
Clinical trial NCT05463744: A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Official title: A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
Acronym: QWINT-5
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 692.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-12
Primary completion date: 2024-05-07
Completion date: 2024-05-07
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.