Type 2 Diabetes MellitusPhase 3VIVIDNCT02561078
An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus
A Phase 3 study testing Human regular U-500 insulin (CSII) and Human regular U-500 insulin (MDI) in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 57 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Human regular U-500 insulin (CSII) and Human regular U-500 insulin (MDI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 57 sitesin 2 countries
- Study dates
- 20 Oct 2015to 9 May 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus (T2DM).
- Current TDD >200 but ≤600 units of non U-500R insulin (MDI or CSII) and/or U-500R by MDI with syringe and vial for ≥3 months at entry.
- If TDD of U-500R and other insulins are combined, then insulin other than U-500R not to exceed 25% of TDD.
- HbA1c ≥7.5% and ≤12.0%.
- Body mass index ≥25 but ≤50 kilograms per meter squared.
- Have a history of stable body weight.
- Concomitant antihyperglycemic agent (AHA) therapy may include metformin (MET), dipeptidyl peptidase-4 inhibitors and/or pioglitazone.
- Approximately 64 to 96 subjects using glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors will be enrolled in Study Group B.
Who cannot join
- Diagnosed with type 1 diabetes mellitus (T1DM) or other types of diabetes apart from T2DM.
- Have obvious clinical or radiographic signs or symptoms of liver disease (except nonalcoholic fatty liver disease), cirrhosis, acute or chronic hepatitis, or alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) levels ≥2.5X upper limit of normal (ULN), alkaline phosphatase ≥2X ULN or total bilirubin ≥2X ULN.
- Have chronic kidney disease Stage 4 and higher or history of renal transplantation.
- Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to screening.
- Have received U-500R insulin by CSII in the 3 months prior to screening.
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
Show all 14Show fewer
- Are taking chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy.
- Have an irregular sleep/wake cycle.
- Have used any weight loss drugs in the 3 months prior to screening.
- Have a history of bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve.
- Have a history of an active or untreated malignancy, or in remission from a clinically significant malignancy during the last 5 years before screening.
- Significant hearing loss and/or vision impairment deemed by the investigator to interfere with the safe use of OmniPod U-500 system.
- Have cardiac disease with functional status that is New York Heart Association (NYHA) Class III or IV per New York Heart Association Cardiac Disease Functional Classification or have congestive heart failure requiring pharmacologic treatment.
- Are women breastfeeding or pregnant, or intend to become pregnant during the course of the study; are men who intend to impregnate their partners; or are sexually active of procreation potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United States52 sites
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
Texas Diabetes and Endocrinology-Austin South
Austin, Texas, 78749
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133
Billings Clinic Research Center
Billings, Montana, 59101
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, 48302
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37411
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
John Muir Physician Network Clinical Research Center
Concord, California, 94520
ALL Medical Research, LLC
Cooper City, Florida, 33024
Midwest CRC
Crystal Lake, Illinois, 60012
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
Iderc, P.L.C.
Des Moines, Iowa, 50314
Dr. Larry Stonesifer
Federal Way, Washington, 98003
Valley Endocrine, Fresno
Fresno, California, 93720
Physicians East
Greenville, North Carolina, 27834
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
East Coast Institute For Research, LLC
Jacksonville, Florida, 32216
JCMG Clinical Research
Jefferson City, Missouri, 65109
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
Diabetes and Endocrine Associates
La Mesa, California, 91942
First Valley Medical Group
Lancaster, California, 93534
Palm Research Center
Las Vegas, Nevada, 89128
Palm Research Center
Las Vegas, Nevada, 89148
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503
Adult Endocrinology Consultants, P.C.
Livonia, Michigan, 48154
East Coast Institute For Research, LLC
Macon, Georgia, 31210
Internal Medicine Center LLC
Mobile, Alabama, 36608
The Arthritis & Diabetes Clinic Inc.
Monroe, Louisiana, 71203
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03063
Vanderbilt Univeristy School of Medicine
Nashville, Tennessee, 37232
North Shore Diabetes and Endocrine Assoc
New Hyde Park, New York, 11040
Suncoast Clinical Research
New Port Richey, Florida, 34652
Pacific Research Partners, LLC
Oakland, California, 94607
University of Oklahoma Health Sciences Center-Tulsa
Oklahoma City, Oklahoma, 73104
Diabetes and Endocrinology Associates
Omaha, Nebraska, 68114
Endocrine Metabolic Associates, P.C.
Philadelphia, Pennsylvania, 19114
Partners in Nephrology & Endocrinology
Pittsburgh, Pennsylvania, 15224
Portland Diabetes & Endocrine Center
Portland, Oregon, 97210
Rainier Clinical Research Center
Renton, Washington, 98057
Inland Empire Liver Foundation
Rialto, California, 92377
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804
NorCal Endocrinology and Internal Medicine - Roseville
Roseville, California, 95661
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, 78681
NorCal Endocrinology and Internal Medicine - Roseville
San Ramon, California, 94583
Advanced Research Institute
South Ogden, Utah, 84405
Northside Internal Medicine
Spokane, Washington, 99208
HSHS Medical Group Diabetes Research
Springfield, Illinois, 62711
Olive View Medical Center
Sylmar, California, 91342
Multicare Health System
Tacoma, Washington, 98405
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606
Sudhir Bansal M.D. Inc.
Warwick, Rhode Island, 02886
Metabolic Research Institute Inc.
West Palm Beach, Florida, 33401
Puerto Rico5 sites
Dr Altagracia Aurora Alcantara Gonzalez
Bayamón, 00956
Manati Center for Clinical Research Inc
Manati, 00674
Endocrine Lipid Diabetes Research Institute
Ponce, 00717
American Telemedicine Center
San Juan, 00917
Martha Gomez Cuellar M.D.
San Juan, 00921
About this study
Official title: Safety and Efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Human regular U-500 insulin (CSII), Human regular U-500 insulin (MDI)
- Keywords
- insulin pumps, concentrated insulin, OmniPod
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human regular U-500 insulin (CSII)Drug
Also called LY041001
Administered SC
Human regular U-500 insulin (MDI)Drug
Also called LY041001
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Human regular U-500 insulin administered by CSII | Experimental | Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in. Receives: Drug: Human regular U-500 insulin (CSII) |
| Human regular U-500 insulin administered by MDI | Active comparator | Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks. Receives: Drug: Human regular U-500 insulin (MDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.
Measured: Baseline, 26 Weeks
Secondary outcomes (8)
Change From Baseline in Fasting Plasma Glucose (FPG)
Fasting plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.
Measured: Baseline, 26 Weeks
Percentage of Participants With HbA1c <7.0%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Longitudinal logistic regression was used to model the likelihood of having hbA1c<7.0% at Week 26 with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.
Measured: 26 Weeks
Percentage of Participants With HbA1c <7.5%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Longitudinal logistic regression was used to model the likelihood of having hbA1c<7.5% at Week 26 with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.
Measured: 26 Weeks
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, Bed Time and 03:00 AM hours. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction.
Measured: Baseline, 26 Weeks
Change From Baseline in Total Daily Dose (TDD)
Baseline TDD was defined as the last prestudy insulin TDD prior to randomization to receiving the first dose of U-500 insulin post randomization. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction.
Measured: Baseline, 26 Weeks
Percentage of Participants With Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)
The percentage of participants with hypoglycemic episodes (documented hypoglycemia) was calculated by dividing the number of participants with at least 1 hypoglycemic episode (documented hypoglycemia) over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. Logistic regression was used to estimate the odds ratio between the two treatments of at least 1 hypoglycemic episode (documented hypoglycemia) over 26 week treatment period adjusted for baseline documented hypoglycemia rate, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, time and treatment by time interaction.
Measured: 26 Weeks
Rate of Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)
Documented Hypoglycemic episodes with blood glucose<=70mg/dL was used in this outcome measure. Hypoglycemia rate (documented hypoglycemia) per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia (documented hypoglycemia) was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline documented hypoglycemia rate, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, with log of exposure in days divided by 30 as the offset, treatment, visit, and visit by treatment interaction.
Measured: Baseline to 26 Weeks
Change From Baseline in Body Weight
Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, GLP-1 or SGLT2 use, U-500R at entry, baseline HbA1C group, treatment, treatment by time interaction.
Measured: Baseline, 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study start20 Oct 2015
- Primary completion9 May 2017
- Study completion9 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Insulet Corporation
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561078
- Sponsor's protocol ID
- 14902
- Other IDs
- B5K-MC-IBHD
- Acronym
- VIVID
- Status last verified
- Aug 2018
- First submitted
- 23 Sep 2015
- Last updated
- 20 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial
- ClinicalTrials.gov ID
- NCT02561078
- Acronym / sponsor ID
- VIVID / 14902
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- insulin pumps, concentrated insulin, OmniPod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Insulet Corporation
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Posted 20 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human regular U-500 insulin administered by CSII | Experimental | Drug: Human regular U-500 insulin (CSII)Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in. |
| Human regular U-500 insulin administered by MDI | Active comparator | Drug: Human regular U-500 insulin (MDI)Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with type 2 diabetes mellitus (T2DM).
- Current TDD >200 but ≤600 units of non U-500R insulin (MDI or CSII) and/or U-500R by MDI with syringe and vial for ≥3 months at entry.
- HbA1c ≥7.5% and ≤12.0%.
- Body mass index ≥25 but ≤50 kilograms per meter squared.
- Have a history of stable body weight.
Key exclusion criteria (14 listed)
- Diagnosed with type 1 diabetes mellitus (T1DM) or other types of diabetes apart from T2DM.
- Have obvious clinical or radiographic signs or symptoms of liver disease (except nonalcoholic fatty liver disease), cirrhosis, acute or chronic hepatitis, or alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) levels ≥2.5X upper limit of normal (ULN), alkaline phosphatase ≥2X ULN or total bilirubin ≥2X ULN.
- Have chronic kidney disease Stage 4 and higher or history of renal transplantation.
- Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to screening.
- Have received U-500R insulin by CSII in the 3 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human regular U-500 insulin (CSII)Also: LY041001Administered SC | Drug | Human regular U-500 insulin administered by CSII |
| Human regular U-500 insulin (MDI)Also: LY041001Administered SC | Drug | Human regular U-500 insulin administered by MDI |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 26 Weeks
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.
8 secondary outcomes
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline, 26 Weeks
Percentage of Participants With HbA1c <7.0%
Time frame: 26 Weeks
Percentage of Participants With HbA1c <7.5%
Time frame: 26 Weeks
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Time frame: Baseline, 26 Weeks
Change From Baseline in Total Daily Dose (TDD)
Time frame: Baseline, 26 Weeks
Percentage of Participants With Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)
Time frame: 26 Weeks
Rate of Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)
Time frame: Baseline to 26 Weeks
Change From Baseline in Body Weight
Time frame: Baseline, 26 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes MellitusLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human regular U-500 insulin (CSII) and Human regular U-500 insulin (MDI) in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 57 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020; AzTrials last refreshed its copy on 30 Oct 2026.