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Type 2 Diabetes MellitusPhase 3SOTA-GLIMNCT03332771

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

A Phase 3 study testing Sotagliflozin (SAR439954), Glimepiride and Metformin in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 142 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sotagliflozin (SAR439954), Glimepiride and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
954 participants
Where
142 sitesin 4 countries
Study dates
1 Dec 2017to 6 Sep 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with Type 2 Diabetes (T2D) treated with metformin at a stable dose ≥1500 milligrams per day (mg/day) or maximum tolerated dose (documented) for at least 12 weeks prior to Screening Visit; in case of documented lack of tolerance, metformin dose <1500 mg/day is acceptable, and the dose should be stable for at least 12 weeks prior to Screening Visit.
  • Participants has given written informed consent to participate in the study in accordance with local regulations.

Who cannot join

  • Age <18 years at the Screening Visit or <legal age of majority, whichever is greater.
  • Type 1 diabetes mellitus.
  • HbA1c, HbA1c <7.0% or HbA1c >10% at Screening.
  • Fasting Plasma Glucose (FPG) >15 millimoles per liter (mmol/L) (>270 milligram per deciliter [mg/dL]) measured by the central laboratory at Screening (Visit 1) and confirmed by a repeat test (>15 mmol/L [>270 mg/dL]) before randomization.
  • Body mass index ≤20 or >45 kilogram per meter square (kg/m^2) at Screening.
  • Pregnant (confirmed by pregnancy test at the Screening) or breast-feeding women.
Show all 26Show fewer
  • Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy (see Appendix A) during the study.
  • Previous use of any antidiabetic drug other than Metformin within 12 weeks preceding the Screening Visit.
  • Use of a selective Sodium-glucose co-transporter-2 (SGLT2) inhibitor (e.g., Canagliflozin, Dapagliflozin, or Empagliflozin) within 3 months prior to the Screening visit.
  • Use of systemic glucocorticoids (excluding topical, or ophthalmic application, intra-articular, nasal spray or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
  • Previous insulin use >1 month (at any time, except for treatment of gestational diabetes).
  • History of prior gastric surgical procedure, including gastric banding, or inflammatory bowel disease within 3 years prior to the Screening Visit.
  • Difficulty swallowing such that the participants cannot take the investigational medicinal product (IMP).
  • History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
  • Mean of 3 separate blood pressure measurements >180 millimeter of mercury (mmHg) (SBP) or >100 mmHg (DBP).
  • History of hypertensive emergency within 12 weeks prior to Screening.
  • Participants who have previously been randomized in any clinical trial of Sotagliflozin/LX4211.
  • Participants with severe renal disease as defined by an estimated glomerular filtration rate (eGFR) of <30 milliliter per minute per meter square (mL/min/1.73 m^2) at Screening, based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation (or according to the renal function restrictions of metformin use defined in the local approved label).
  • Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease that, according to Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
  • Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN).
  • Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome).
  • Participants who have taken other investigational drugs within 12 weeks or 5 half-lives from Screening whichever is longer.
  • Participants unwilling or unable to perform self-monitoring blood glucose (SMBG), complete the participant diary, or comply with study visits and other study procedures as required per protocol.
  • Participants with contraindication to glimepiride as per local labelling.
  • Participants with contraindication to metformin as per local labelling.
  • The above information is not intended to contain all considerations relevant to a Participants potential participation in a clinical trial.

Trial locations and contacts

142 sites in 4 countries.

142 sites in 4 countries

United States115 sites

  • Investigational Site Number 8407050

    Albuquerque, New Mexico, 87106

  • Investigational Site Number 8407051

    Anaheim, California, 92801-2417

  • Investigational Site Number 8407026

    Austin, Texas, 78735-8982

  • Investigational Site Number 8407085

    Baltimore, Maryland, 21237

  • Investigational Site Number 8407029

    Beaumont, Texas, 77702

  • Investigational Site Number 8407104

    Beaver, Pennsylvania, 15009-1957

  • Investigational Site Number 8407040

    Birmingham, Alabama, 35205

  • Investigational Site Number 8407048

    Birmingham, Alabama, 35233-2110

  • Investigational Site Number 8407074

    Bradenton, Florida, 34201

  • Investigational Site Number 8407054

    Bridgeton, Missouri, 63044

  • Investigational Site Number 8407065

    Canoga Park, California, 91301

  • Investigational Site Number 8407078

    Carmichael, California, 95608

  • Investigational Site Number 8407070

    Carrollton, Texas, 75010

  • Investigational Site Number 8407016

    Charleston, South Carolina, 29407

  • Investigational Site Number 8407017

    Chicago, Illinois, 60607

  • Investigational Site Number 8407099

    Cincinnati, Ohio, 45245

  • Investigational Site Number 8407027

    Clearwater, Florida, 33761

  • Investigational Site Number 8407063

    Clinton, Utah, 84015

  • Investigational Site Number 8407045

    Colorado Springs, Colorado, 80920-8075

  • Investigational Site Number 8407103

    Cooper City, Florida, 33024

  • Investigational Site Number 8407021

    Coral Gables, Florida, 33134

  • Investigational Site Number 8407102

    Corpus Christi, Texas, 78414-4173

  • Investigational Site Number 8407023

    Dallas, Texas, 75230

  • Investigational Site Number 8407111

    Dallas, Texas, 75231

  • Investigational Site Number 8407089

    Downey, California, 90242

  • Investigational Site Number 8407018

    Elgin, Illinois, 60124

  • Investigational Site Number 8407068

    Eugene, Oregon, 97404

  • Investigational Site Number 8407013

    Fort Worth, Texas, 76164

  • Investigational Site Number 8407011

    Gold River, California, 95670

  • Investigational Site Number 8407044

    Greenbrae, California, 94904

  • Investigational Site Number 8407020

    Greensboro, North Carolina, 27408

  • Investigational Site Number 8407071

    Greer, South Carolina, 29651-1817

  • Investigational Site Number 8407046

    Gurnee, Illinois, 60031

  • Investigational Site Number 8407025

    Hatboro, Pennsylvania, 19040-2045

  • Investigational Site Number 8407055

    Holladay, Utah, 84117-7054

  • Investigational Site Number 8407080

    Houston, Texas, 77040

  • Investigational Site Number 8407088

    Houston, Texas, 77095-2856

  • Investigational Site Number 8407006

    Huntington Park, California, 90255-2911

  • Investigational Site Number 8407014

    Jefferson City, Tennessee, 37760

  • Investigational Site Number 8407090

    Katy, Texas, 77450

  • Investigational Site Number 8407002

    Knoxville, Tennessee, 37938

  • Investigational Site Number 8407060

    Lake Charles, Louisiana, 70601

  • Investigational Site Number 8407062

    Lake Worth, Florida, 33467

  • Investigational Site Number 8407042

    Lampasas, Texas, 76550-1820

  • Investigational Site Number 8407053

    Lansdale, Pennsylvania, 19446-1002

  • Investigational Site Number 8407108

    Las Vegas, Nevada, 89106-4132

  • Investigational Site Number 8407037

    Lemon Grove, California, 91945

  • Investigational Site Number 8407114

    Lenoir, North Carolina, 28645-8981

  • Investigational Site Number 8407043

    Lexington, Kentucky, 40503-2517

  • Investigational Site Number 8407087

    Lexington, Kentucky, 40503

  • Investigational Site Number 8407035

    Little Rock, Arkansas, 72211

  • Investigational Site Number 8407100

    Lomita, California, 90717

  • Investigational Site Number 8407033

    Long Beach, California, 90806

  • Investigational Site Number 8407019

    Los Angeles, California, 90057-3507

  • Investigational Site Number 8407067

    Lufkin, Texas, 75904

  • Investigational Site Number 8407118

    Lufkin, Texas, 75904

  • Investigational Site Number 8407081

    Lyndhurst, Ohio, 44124-2467

  • Investigational Site Number 8407124

    Manassas, Virginia, 20110-4421

  • Investigational Site Number 8407059

    McAllen, Texas, 78504

  • Investigational Site Number 8407056

    Memphis, Tennessee, 38163

  • Investigational Site Number 8407012

    Mesquite, Texas, 75149

  • Investigational Site Number 8407015

    Morehead City, North Carolina, 28557

  • Investigational Site Number 8407022

    Mt. Pleasant, South Carolina, 29464

  • Investigational Site Number 8407031

    Mt. Pleasant, South Carolina, 29464

  • Investigational Site Number 8407058

    New Orleans, Louisiana, 70119

  • Investigational Site Number 8407009

    New Orleans, Louisiana, 70124

  • Investigational Site Number 8407116

    New York, New York, 10016-6402

  • Investigational Site Number 8407086

    New York, New York, 10029

  • Investigational Site Number 8407122

    New York, New York, 10036

  • Investigational Site Number 8407049

    Norfolk, Nebraska, 68701

  • Investigational Site Number 8407057

    Norman, Oklahoma, 73069

  • Investigational Site Number 8407098

    Northridge, California, 91325-5409

  • Investigational Site Number 8407094

    Norwalk, California, 90650

  • Investigational Site Number 8407121

    Ocoee, Florida, 34761

  • Investigational Site Number 8407097

    Ogden, Utah, 84405

  • Investigational Site Number 8407073

    Oklahoma City, Oklahoma, 73104-3252

  • Investigational Site Number 8407110

    Olive Branch, Mississippi, 38654

  • Investigational Site Number 8407039

    Omaha, Nebraska, 68114

  • Investigational Site Number 8407024

    Orlando, Florida, 32825-4454

  • Investigational Site Number 8407038

    Palmetto Bay, Florida, 33157-5503

  • Investigational Site Number 8407061

    Papillion, Nebraska, 68046-3136

  • Investigational Site Number 8407093

    Pembroke Pines, Florida, 33026-3924

  • Investigational Site Number 8407007

    Plano, Texas, 75075

  • Investigational Site Number 8407106

    Pomona, California, 91766

  • Investigational Site Number 8407096

    Rancho Cucamonga, California, 91730

  • Investigational Site Number 8407028

    Renton, Washington, 98055

  • Investigational Site Number 8407105

    Richmond, Virginia, 23249-0001

  • Investigational Site Number 8407001

    Rockville, Maryland, 20852

  • Investigational Site Number 8407036

    Sacramento, California, 95821

  • Investigational Site Number 8407030

    Salisbury, North Carolina, 28144-2742

  • Investigational Site Number 8407072

    Salt Lake City, Utah, 84102-1553

  • Investigational Site Number 8407005

    San Antonio, Texas, 78218

  • Investigational Site Number 8407064

    San Antonio, Texas, 78229-3818

  • Investigational Site Number 8407010

    Schertz, Texas, 78154

  • Investigational Site Number 8407076

    Splendora, Texas, 77372

  • Investigational Site Number 8407107

    Spring Hill, Florida, 34609

  • Investigational Site Number 8407119

    Springfield, Illinois, 62711

  • Investigational Site Number 8407091

    Tampa, Florida, 33619

  • Investigational Site Number 8407113

    Tampa, Florida, 33634

  • Investigational Site Number 8407084

    Tarzana, California, 91356-3551

  • Investigational Site Number 8407095

    Topeka, Kansas, 66606-2806

  • Investigational Site Number 8407069

    Troy, Michigan, 48098-6334

  • Investigational Site Number 8407034

    Upland, California, 91786-4070

  • Investigational Site Number 8407032

    Van Nuys, California, 91405

  • Investigational Site Number 8407004

    Walnut Creek, California, 94598

  • Investigational Site Number 8407075

    Waterloo, Iowa, 50702

  • Investigational Site Number 8407120

    West Des Moines, Iowa, 50265

  • Investigational Site Number 8407092

    West Palm Beach, Florida, 33401

  • Investigational Site Number 8407123

    West Seneca, New York, 14224

  • Investigational Site Number 8407083

    Wichita, Kansas, 67205-1138

  • Investigational Site Number 8407117

    Wildomar, California, 92595

  • Investigational Site Number 8407041

    Wilmington, North Carolina, 28401-6638

  • Investigational Site Number 8407101

    Winston-Salem, North Carolina, 27103

  • Investigational Site Number 8407115

    Winter Haven, Florida, 33880

  • Investigational Site Number 8407079

    Zachary, Louisiana, 70791-4010

Other trials in United States

Slovakia10 sites

  • Investigational Site Number 7037004

    Bardejov, 085 01

  • Investigational Site Number 7037008

    Bratislava, 831 06

  • Investigational Site Number 7037007

    Bratislava, 85101

  • Investigational Site Number 7037005

    Košice, 4014

  • Investigational Site Number 7037002

    Levice, 934 01

  • Investigational Site Number 7037010

    Nitra, 94901

  • Investigational Site Number 7037009

    Rožňava, 048 01

  • Investigational Site Number 7037001

    Sabinov, 08301

  • Investigational Site Number 7037003

    Trnava, 91701

  • Investigational Site Number 7037006

    Vrútky, 038 61

Other trials in Slovakia

Bulgaria9 sites

  • Investigational Site Number 1007002

    Gabrovo, 5300

  • Investigational Site Number 1007008

    Plovdiv, 4000

  • Investigational Site Number 1007003

    Plovdiv, 4002

  • Investigational Site Number 1007001

    Rousse, 7003

  • Investigational Site Number 1007004

    Smolyan, 4700

  • Investigational Site Number 1007009

    Sofia, 1632

  • Investigational Site Number 1007005

    Stara Zagora, 6000

  • Investigational Site Number 1007006

    Stara Zagora, 6000

  • Investigational Site Number 1007007

    Varna, 9000

Other trials in Bulgaria

Hungary8 sites

  • Investigational Site Number 3487005

    Balatonfüred, 8230

  • Investigational Site Number 3487001

    Budapest, 1033

  • Investigational Site Number 3487010

    Budapest, 1134

  • Investigational Site Number 3487006

    Debrecen, 4025

  • Investigational Site Number 3487008

    Debrecen, 4032

  • Investigational Site Number 3487002

    Kecskemét, 6000

  • Investigational Site Number 3487004

    Nyíregyháza, 4400

  • Investigational Site Number 3487007

    Nyíregyháza, 4405

Other trials in Hungary

About this study

Official title: A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy

Primary Objective:

To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin.

Read more

Secondary Objectives:

To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter [mg/dL]).

  • To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants.
  • To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c.
  • To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
  • To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
  • To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.
Read the detailed description

Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period, and a 2-week post-treatment Follow-up period to collect safety information.

Being tested
Sotagliflozin (SAR439954), Glimepiride, Metformin, Placebo
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.

  • Sotagliflozin (SAR439954)Drug

    Pharmaceutical form: tablet

    Route of administration: oral

  • GlimepirideDrug

    Pharmaceutical form: capsule

    Route of administration: oral

  • MetforminDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • PlaceboDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • PlaceboDrug

    Pharmaceutical form: capsule

    Route of administration: oral

Study groups in NCT03332771
Study groupRoleWhat they receive
Sotagliflozin 400 mgExperimentalFollowing a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Receives: Drug: Sotagliflozin (SAR439954); Drug: Metformin; Drug: Placebo
Sotagliflozin 200 mgExperimentalFollowing a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Receives: Drug: Sotagliflozin (SAR439954); Drug: Metformin; Drug: Placebo
GlimepirideActive comparatorFollowing a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Receives: Drug: Glimepiride; Drug: Metformin; Drug: Placebo
PlaceboPlacebo comparatorFollowing a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
Receives: Drug: Metformin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Hemoglobin A1c at Week 52

    An analysis of covariance (ANCOVA) model was used for the analysis.

    Measured: Baseline, Week 52

Secondary outcomes (6)

  1. Change From Baseline in Hemoglobin A1c at Week 26

    An ANCOVA model was used for the analysis.

    Measured: Baseline, Week 26

  2. Change From Baseline in Body Weight at Week 26 and 52

    An ANCOVA model was used for the analysis.

    Measured: Baseline, Week 26, Week 52

  3. Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12

    An ANCOVA model was used for the analysis.

    Measured: Baseline, Week 12

  4. Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12

    An ANCOVA model was used for the analysis.

    Measured: Baseline, Week 12

  5. Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event

    Documented symptomatic hypoglycemia includes the typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L).

    Measured: Up to Week 52

  6. Percentage of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start1 Dec 2017
  3. Primary completion6 Aug 2019
  4. Study completion6 Sep 2019

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
954 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03332771
Sponsor's protocol ID
EFC14838
Other IDs
2016-001801-17, U1111-1190-7596, 2016
Acronym
SOTA-GLIM
Status last verified
Apr 2021
First submitted
2 Nov 2017
Last updated
11 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin (SAR439954), Glimepiride and Metformin in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 142 sites in 4 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 2 inclusion and 26 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Slovakia, Bulgaria, Hungary. 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. Some participants in this study may receive a placebo. 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 11 May 2021). 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 at Week 52 (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03332771.

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 11 May 2021.

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