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Diabetes Mellitus, Type 2Phase 3NCT01128894

A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

A Phase 3 study testing albiglutide and liraglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 173 sites in 8 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

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
albiglutide and liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
841 participants
Where
173 sitesin 8 countries
Study dates
May 2010to Sep 2011
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

  • Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
  • BMI >/=20kg/m2 and </=45 kg/m2
  • Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
  • HbA1c between 7.0% and 10.0%, inclusive
  • Female subjects of childbearing potential must be practicing adequate contraception.

Who cannot join

  • History of cancer
  • History of treated diabetic gastroparesis
  • Current biliary disease or history of pancreatitis
  • History of significant GI surgery
  • Recent clinically significant cardiovascular and/or cerebrovascular disease
  • Hypertension
Show all 15Show fewer
  • History of human immunodeficiency virus infection
  • History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
  • History of alcohol or substance abuse
  • Female subject is pregnant, lactating, or <6 weeks postpartum
  • Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
  • History of type 1 diabetes mellitus
  • Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
  • Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
  • History or family history of thyroid disease

Trial locations and contacts

173 sites in 8 countries.

173 sites in 8 countries

United States129 sites

  • GSK Investigational Site

    Arlington, Texas, 76012

  • GSK Investigational Site

    Atlanta, Georgia, 30309

  • GSK Investigational Site

    Atlanta, Georgia, 30312

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Bloomfield Hills, Michigan, 48302

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Bountiful, Utah, 84010

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Burke, Virginia, 22015

  • GSK Investigational Site

    Burlington, North Carolina, 27215

  • GSK Investigational Site

    Canal Fulton, Ohio, 44614

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Chula Vista, California, 91910

  • GSK Investigational Site

    Clarksville, Tennessee, 37043

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Cleveland, Ohio, 44122

  • GSK Investigational Site

    Cocoa, Florida, 32927

  • GSK Investigational Site

    Columbus, Ohio, 43213

  • GSK Investigational Site

    Corpus Christi, Texas, 78404

  • GSK Investigational Site

    Council Bluffs, Iowa, 51501

  • GSK Investigational Site

    Covington, Louisiana, 70433

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Dallas, Texas, 75251

  • GSK Investigational Site

    Dayton, Ohio, 45439

  • GSK Investigational Site

    Dearborn, Michigan, 48124

  • GSK Investigational Site

    Detroit, Michigan, 48235

  • GSK Investigational Site

    Downington, Pennsylvania, 19335

  • GSK Investigational Site

    Draper, Utah, 84020

  • GSK Investigational Site

    Dubuque, Iowa, 52001

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Elizabeth, New Jersey, 07202

  • GSK Investigational Site

    Escondido, California, 92026

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gallipolis, Ohio, 45631

  • GSK Investigational Site

    Gilbert, Arizona, 85295

  • GSK Investigational Site

    Greensboro, North Carolina, 27405

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Haddon Heights, New Jersey, 08035

  • GSK Investigational Site

    Haverhill, Massachusetts, 01830

  • GSK Investigational Site

    Honolulu, Hawaii, 96814

  • GSK Investigational Site

    Houston, Texas, 77036

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Houston, Texas, 77088

  • GSK Investigational Site

    Huntington Beach, California, 92648

  • GSK Investigational Site

    Hurst, Texas, 76054

  • GSK Investigational Site

    Idaho Falls, Idaho, 83404

  • GSK Investigational Site

    Indio, California, 92201

  • GSK Investigational Site

    Irvine, California, 92618

  • GSK Investigational Site

    Kalamazoo, Michigan, 49009

  • GSK Investigational Site

    Kalamazoo, Michigan, 49048

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Katy, Texas, 77450

  • GSK Investigational Site

    Kettering, Ohio, 45429

  • GSK Investigational Site

    La Grange, Illinois, 60525

  • GSK Investigational Site

    Las Vegas, Nevada, 89102

  • GSK Investigational Site

    Las Vegas, Nevada, 89103

  • GSK Investigational Site

    Lenoir, North Carolina, 28645

  • GSK Investigational Site

    Lexington, Kentucky, 40504

  • GSK Investigational Site

    Lincoln, Nebraska, 68516

  • GSK Investigational Site

    Los Angeles, California, 90017

  • GSK Investigational Site

    Los Angeles, California, 90022

  • GSK Investigational Site

    Manassas, Virginia, 20110

  • GSK Investigational Site

    Memphis, Tennessee, 38125

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Midland, Texas, 79707

  • GSK Investigational Site

    Minneapolis, Minnesota, 55430

  • GSK Investigational Site

    Mission Viejo, California, 92691

  • GSK Investigational Site

    Morehead City, North Carolina, 28557

  • GSK Investigational Site

    Murrells Inlet, South Carolina, 29576

  • GSK Investigational Site

    North Massapequa, New York, 11758

  • GSK Investigational Site

    North Miami, Florida, 33161

  • GSK Investigational Site

    North Richland Hills, Texas, 76180

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Orlando, Florida, 32822

  • GSK Investigational Site

    Paducah, Kentucky, 42003

  • GSK Investigational Site

    Palm Desert, California, 92260

  • GSK Investigational Site

    Pembroke Pines, Florida, 33026

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Picayune, Mississippi, 39466

  • GSK Investigational Site

    Portland, Oregon, 97239

  • GSK Investigational Site

    Richmond, Virginia, 23225

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Roswell, Georgia, 30076

  • GSK Investigational Site

    Saint Clair Shores, Michigan, 48081

  • GSK Investigational Site

    Salem, Virginia, 24153

  • GSK Investigational Site

    San Antonio, Texas, 78215

  • GSK Investigational Site

    San Antonio, Texas, 78217

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78237

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    Satna Monica, California, 90404

  • GSK Investigational Site

    Schertz, Texas, 78154

  • GSK Investigational Site

    Searcy, Arkansas, 72143

  • GSK Investigational Site

    Shelby, North Carolina, 28150

  • GSK Investigational Site

    Shreveport, Louisiana, 71101

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    Spokane, Washington, 99208

  • GSK Investigational Site

    Spokane, Washington, 99216

  • GSK Investigational Site

    Spring Valley, California, 91978

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    St. Petersburg, Florida, 33709

  • GSK Investigational Site

    Staten Island, New York, 10301

  • GSK Investigational Site

    Stone Mountain, Georgia, 30088

  • GSK Investigational Site

    Sugarland, Texas, 77479

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Tarzana, California, 91356

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tullahoma, Tennessee, 37398

  • GSK Investigational Site

    Tustin, California, 92780

  • GSK Investigational Site

    Valparaiso, Indiana, 46383

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    West Hills, California, 91307

  • GSK Investigational Site

    West Jordan, Utah, 84088

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Winter Park, Florida, 32789

  • GSK Investigational Site

    Winter Park, Florida, 32792

Other trials in United States

Australia9 sites

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Fremantle, Western Australia, 6160

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2606

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Heidelberg, Victoria, 3081

  • GSK Investigational Site

    Herston, Queensland, 4029

  • GSK Investigational Site

    Ringwood East, Victoria, 3135

  • GSK Investigational Site

    St Leonards, New South Wales, 2065

Other trials in Australia

Peru7 sites

  • GSK Investigational Site

    Callao, Lima, Callao 2

  • GSK Investigational Site

    Huacho, Lima region

  • GSK Investigational Site

    Ica, Ica, 11

  • GSK Investigational Site

    Lima, Lima Province, 01

  • GSK Investigational Site

    Lima, Lima Province, 17

  • GSK Investigational Site

    Lima, Lima 1

  • GSK Investigational Site

    Piura, Piura

Other trials in Peru

South Korea7 sites

  • GSK Investigational Site

    Goyang, 414410

  • GSK Investigational Site

    Seongnam-si, 463-707

  • GSK Investigational Site

    Seongnam-si, 463712

  • GSK Investigational Site

    Seoul, 135720

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 139-872

Other trials in South Korea

Philippines6 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Iloilo City, 5000

  • GSK Investigational Site

    Makati City, 1218

  • GSK Investigational Site

    Marikina City, 1810

  • GSK Investigational Site

    Pasay, 1300

  • GSK Investigational Site

    Pasig, 1600

Other trials in Philippines

Spain6 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alicante, 03114

  • GSK Investigational Site

    Majadahonda (Madrid), 28222

  • GSK Investigational Site

    Modulo H, 07120

  • GSK Investigational Site

    Sabadell, 08208

  • GSK Investigational Site

    Torrevieja (Alicante), 03186

Other trials in Spain

United Kingdom5 sites

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Hertfordshire

  • GSK Investigational Site

    Livingston, EH54 6PP

  • GSK Investigational Site

    London, London, SE1 9RT

  • GSK Investigational Site

    Swansea, SA6 6NL

Other trials in United Kingdom

Israel4 sites

  • GSK Investigational Site

    Beersheba, 84101

  • GSK Investigational Site

    Haifa, 35251

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Nahariya, 22100

Other trials in Israel

About this study

Official title: A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Read the detailed description

This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.

Being tested
albiglutide, liraglutide
Keywords
GSK716155, liraglutide, albiglutide, open-label
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.

  • albiglutideBiological

    albiglutide weekly subcutaneous injection

  • liraglutideDrug

    liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

Study groups in NCT01128894
Study groupRoleWhat they receive
albiglutideExperimentalweekly albiglutide subcutaneous injection
Receives: Biological: albiglutide
liraglutideActive comparatorliraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Receives: Drug: liraglutide

What is being measured

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

  1. Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

    Measured: Baseline and Week 32

Secondary outcomes (6)

  1. Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.

    Measured: Baseline, Weeks 4, 6, 12, 18 and 26

  2. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32

    The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.

    Measured: Baseline and Week 32

  3. Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26

    The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.

    Measured: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26

  4. Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32

    Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

    Measured: Week 32

  5. Time to Hyperglycemia Rescue at Week 32

    Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and <Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- >= Week 12 and <Week 26, or HbA1c ≥8.5% >= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.

    Measured: Week 32

  6. Mean Change From Baseline in Body Weight at Week 32

    The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.

    Measured: Baseline and Week 32

Timeline

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

  1. First posted24 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2011
  4. Study completionSep 2011

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
None (open label)
Enrolment
841 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01128894
Sponsor's protocol ID
114179
Status last verified
Jan 2017
First submitted
29 Apr 2010
Last updated
23 Feb 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Pratley RE, Nauck MA, Barnett AH, Feinglos MN, Ovalle F, Harman-Boehm I, Ye J, Scott R, Johnson S, Stewart M, Rosenstock J; HARMONY 7 study group. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol. 2014 Apr;2(4):289-297. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6.

    PubMed 24703047

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing albiglutide and liraglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 173 sites in 8 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 5 inclusion and 15 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United States, Australia, Peru, South Korea, Philippines and 3 more countries. 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 2014). 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?

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32 (time frame: Baseline and Week 32). 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 NCT01128894, which also lists 1 linked publication.

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 23 Feb 2017.

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