MedDataX Logo

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

NCT ID: NCT00763815

Last Updated: 2016-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function \[HOMA-beta\]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the schedule date of Week 76 visit (Visit 25) for the last randomized patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type 2

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hyperglycemia GLP-1 pioglitazone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lixisenatide

2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.

Group Type EXPERIMENTAL

Lixisenatide (AVE0010)

Intervention Type DRUG

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Pen auto-injector

Intervention Type DEVICE

Pioglitazone

Intervention Type DRUG

Dose to be kept stable.

Metformin

Intervention Type DRUG

Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Placebo

2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Pen auto-injector

Intervention Type DEVICE

Pioglitazone

Intervention Type DRUG

Dose to be kept stable.

Metformin

Intervention Type DRUG

Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lixisenatide (AVE0010)

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Intervention Type DRUG

Placebo

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Intervention Type DRUG

Pen auto-injector

Intervention Type DEVICE

Pioglitazone

Dose to be kept stable.

Intervention Type DRUG

Metformin

Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OptiClik®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone

Exclusion Criteria

* HbA1c less than (\<) 7 percent (%) or greater than (\>) 10% at screening
* At the time of screening age \<legal age of majority
* Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
* Type 1 diabetes mellitus
* Pioglitazone not at a stable dose of at least 30 milligram per day (mg/day) for at least 3 months prior to screening
* If treatment with metformin, no stable dose of at least 1.5 gram per day (g/day) for at least 3 months prior to screening visit
* FPG at screening \>250 milligram per deciliter (mg/dL) (\>13.9 millimole per liter \[mmol/L\])
* Body mass index less than or equal to (\<=) 20 kilogram per square meter (kg/m\^2)
* Weight change of more than 5 kg during the 3 months preceding the screening visit
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease
* History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
* Hemoglobinopathy or hemolytic anemia, or receipt of blood or plasma products within3 months prior to the time of screening
* History of myocardial infarction or stroke within the last 6 months prior to screening
* Known history of drug or alcohol abuse within 6 months prior to the time of screening
* Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
* Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure or diastolic blood pressure (DBP) \>180 millimeter of mercury (mmHg) or \>95 mmHg, respectively
* Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): \>2 times upper limit of normal (ULN) laboratory range; amylase and/or lipase: \>3 times ULN; total bilirubin: \>1.5 times ULN (except in case of Gilbert's syndrome); Hemoglobin \<11 gram/deciliter and/or neutrophils \<1500 per cubic millimeter (mm\^3) and/or platelets \<100 000/mm\^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb); positive serum pregnancy test in females of childbearing potential
* Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG), or vital signs at the time of screening that, in the judgment of the investigator or any sub-investigator, precludes safe completion of the study or constrains efficacy assessment
* Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements \[such as scheduled visits, being able to do self-injections\]; likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)
* Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin or pioglitazone (for example, sulfonylurea, alpha-glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, dipeptidyl peptidase-4 \[DPP-4\] inhibitors, insulin) within 3 months prior to the time of screening
* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening
* Use of any investigational drug within 3 months prior to study
* Any previous treatment with lixisenatide or participation in a previous study with lixisenatide
* Renal impairment defined with creatinine \>1.4 mg/dL in women and creatinine \>1.5 mg/dL in men (applicable only for patients with metformin treatment)
* Patients with cardiac failure or history of cardiac failure (New York Heart Association class I to IV)
* End-stage renal disease defined by a serum creatinine clearance of \<15 milliliter per minute (mL/min) (calculated by the Cockcroft and Gault formula) and/or patients on dialysis, if no treatment with metformin
* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
* Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example,exenatide, liraglutide) or to metacresol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanofi-Aventis Investigational Site Number 840723

Birmingham, Alabama, United States

Site Status

Sanofi-Aventis Investigational Site Number 840744

Birmingham, Alabama, United States

Site Status

Sanofi-Aventis Investigational Site Number 840867

Birmingham, Alabama, United States

Site Status

Sanofi-Aventis Investigational Site Number 840720

Birmingham, Alabama, United States

Site Status

Sanofi-Aventis Investigational Site Number 840855

Mobile, Alabama, United States

Site Status

Sanofi-Aventis Investigational Site Number 840863

Mobile, Alabama, United States

Site Status

Sanofi-Aventis Investigational Site Number 840775

Chandler, Arizona, United States

Site Status

Sanofi-Aventis Investigational Site Number 840722

Mesa, Arizona, United States

Site Status

Sanofi-Aventis Investigational Site Number 840769

Phoenix, Arizona, United States

Site Status

Sanofi-Aventis Investigational Site Number 840729

Harrisburg, Arkansas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840776

Mountain Home, Arkansas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840795

Artesia, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840782

Chino, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840785

Huntington Beach, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840858

La Jolla, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840784

Los Banos, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840773

Mission Hills, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840707

Mission Viejo, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840733

Northridge, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840864

Roseville, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840772

San Diego, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840743

San Mateo, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840721

Stockton, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840763

West Hills, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840872

Colorado Springs, Colorado, United States

Site Status

Sanofi-Aventis Investigational Site Number 840868

Colorado Springs, Colorado, United States

Site Status

Sanofi-Aventis Investigational Site Number 840727

Jacksonville, Florida, United States

Site Status

Sanofi-Aventis Investigational Site Number 840745

New Port Richey, Florida, United States

Site Status

Sanofi-Aventis Investigational Site Number 840761

Oviedo, Florida, United States

Site Status

Sanofi-Aventis Investigational Site Number 840799

Wellington, Florida, United States

Site Status

Sanofi-Aventis Investigational Site Number 840857

Augusta, Georgia, United States

Site Status

Sanofi-Aventis Investigational Site Number 840724

Idaho Falls, Idaho, United States

Site Status

Sanofi-Aventis Investigational Site Number 840791

Chicago, Illinois, United States

Site Status

Sanofi-Aventis Investigational Site Number 840738

Avon, Indiana, United States

Site Status

Sanofi-Aventis Investigational Site Number 840794

Indianapolis, Indiana, United States

Site Status

Sanofi-Aventis Investigational Site Number 840767

Kansas City, Kansas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840779

Lansing, Kansas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840739

Wichita, Kansas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840789

Lexington, Kentucky, United States

Site Status

Sanofi-Aventis Investigational Site Number 840850

Lexington, Kentucky, United States

Site Status

Sanofi-Aventis Investigational Site Number 840862

Baton Rouge, Louisiana, United States

Site Status

Sanofi-Aventis Investigational Site Number 840879

Shreveport, Louisiana, United States

Site Status

Sanofi-Aventis Investigational Site Number 840764

Hyattsville, Maryland, United States

Site Status

Sanofi-Aventis Investigational Site Number 840871

Rockville, Maryland, United States

Site Status

Sanofi-Aventis Investigational Site Number 840851

Russells Mills, Massachusetts, United States

Site Status

Sanofi-Aventis Investigational Site Number 840708

Kalamazoo, Michigan, United States

Site Status

Sanofi-Aventis Investigational Site Number 840774

Bloomington, Minnesota, United States

Site Status

Sanofi-Aventis Investigational Site Number 840704

Eagan, Minnesota, United States

Site Status

Sanofi-Aventis Investigational Site Number 840717

Picayune, Mississippi, United States

Site Status

Sanofi-Aventis Investigational Site Number 840765

St Louis, Missouri, United States

Site Status

Sanofi-Aventis Investigational Site Number 840875

Las Vegas, Nevada, United States

Site Status

Sanofi-Aventis Investigational Site Number 840866

Pahrump, Nevada, United States

Site Status

Sanofi-Aventis Investigational Site Number 840865

New York, New York, United States

Site Status

Sanofi-Aventis Investigational Site Number 840766

New York, New York, United States

Site Status

Sanofi-Aventis Investigational Site Number 840874

Staten Island, New York, United States

Site Status

Sanofi-Aventis Investigational Site Number 840762

West Seneca, New York, United States

Site Status

Sanofi-Aventis Investigational Site Number 840747

Burlington, North Carolina, United States

Site Status

Sanofi-Aventis Investigational Site Number 840760

Greensboro, North Carolina, United States

Site Status

Sanofi-Aventis Investigational Site Number 840712

High Point, North Carolina, United States

Site Status

Sanofi-Aventis Investigational Site Number 840780

Bismarck, North Dakota, United States

Site Status

Sanofi-Aventis Investigational Site Number 840877

Fargo, North Dakota, United States

Site Status

Sanofi-Aventis Investigational Site Number 840777

Athens, Ohio, United States

Site Status

Sanofi-Aventis Investigational Site Number 840741

Cleveland, Ohio, United States

Site Status

Sanofi-Aventis Investigational Site Number 840728

Dayton, Ohio, United States

Site Status

Sanofi-Aventis Investigational Site Number 840709

Mentor, Ohio, United States

Site Status

Sanofi-Aventis Investigational Site Number 840716

Norman, Oklahoma, United States

Site Status

Sanofi-Aventis Investigational Site Number 840701

Medford, Oregon, United States

Site Status

Sanofi-Aventis Investigational Site Number 840751

Beaver, Pennsylvania, United States

Site Status

Sanofi-Aventis Investigational Site Number 840798

Red Lion, Pennsylvania, United States

Site Status

Sanofi-Aventis Investigational Site Number 840792

Columbia, South Carolina, United States

Site Status

Sanofi-Aventis Investigational Site Number 840740

Simpsonville, South Carolina, United States

Site Status

Sanofi-Aventis Investigational Site Number 840726

Taylors, South Carolina, United States

Site Status

Sanofi-Aventis Investigational Site Number 840711

Bristol, Tennessee, United States

Site Status

Sanofi-Aventis Investigational Site Number 840853

Colleyville, Texas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840730

Houston, Texas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840854

San Antonio, Texas, United States

Site Status

Sanofi-Aventis Investigational Site Number 840796

Clinton, Utah, United States

Site Status

Sanofi-Aventis Investigational Site Number 840755

Salt Lake City, Utah, United States

Site Status

Sanofi-Aventis Investigational Site Number 840756

Salt Lake City, Utah, United States

Site Status

Sanofi-Aventis Investigational Site Number 840758

Salt Lake City, Utah, United States

Site Status

Sanofi-Aventis Investigational Site Number 840753

Norfolk, Virginia, United States

Site Status

Sanofi-Aventis Investigational Site Number 840770

Norfolk, Virginia, United States

Site Status

Sanofi-Aventis Investigational Site Number 840752

Richmond, Virginia, United States

Site Status

Sanofi-Aventis Investigational Site Number 840757

Virginia Beach, Virginia, United States

Site Status

Sanofi-Aventis Investigational Site Number 840735

Spokane, Washington, United States

Site Status

Sanofi-Aventis Investigational Site Number 040706

Graz, , Austria

Site Status

Sanofi-Aventis Investigational Site Number 040702

Vienna, , Austria

Site Status

Sanofi-Aventis Investigational Site Number 040704

Vienna, , Austria

Site Status

Sanofi-Aventis Investigational Site Number 040701

Vienna, , Austria

Site Status

Sanofi-Aventis Investigational Site Number 040705

Vienna, , Austria

Site Status

Sanofi-Aventis Investigational Site Number 040707

Wels, , Austria

Site Status

Sanofi-Aventis Investigational Site Number 124716

Greater Sudbury, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124710

London, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124712

Mirabel, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124705

Saint Romuald, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124703

Saskatoon, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124713

Scarborough, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124711

Sherbrooke, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124704

Smiths Falls, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124701

Thornhill, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 124708

Vancouver, , Canada

Site Status

Sanofi-Aventis Investigational Site Number 250704

Armentières, , France

Site Status

Sanofi-Aventis Investigational Site Number 250707

La Rochelle, , France

Site Status

Sanofi-Aventis Investigational Site Number 250705

Labarthe-sur-Lèze, , France

Site Status

Sanofi-Aventis Investigational Site Number 250702

Le Creusot, , France

Site Status

Sanofi-Aventis Investigational Site Number 250701

Strasbourg, , France

Site Status

Sanofi-Aventis Investigational Site Number 276708

Aßlar, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276704

Berlin, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276703

Künzing, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276706

Leipzig, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276707

Pirna, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276702

Sulzbach-Rosenberg, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 276701

Würzburg, , Germany

Site Status

Sanofi-Aventis Investigational Site Number 300705

Athens, , Greece

Site Status

Sanofi-Aventis Investigational Site Number 300703

Athens, , Greece

Site Status

Sanofi-Aventis Investigational Site Number 300704

Athens, , Greece

Site Status

Sanofi-Aventis Investigational Site Number 300701

Thessaloniki, , Greece

Site Status

Sanofi-Aventis Investigational Site Number 320702

Guatemala City, , Guatemala

Site Status

Sanofi-Aventis Investigational Site Number 320701

Guatemala City, , Guatemala

Site Status

Sanofi-Aventis Investigational Site Number 320703

Guatemala City, , Guatemala

Site Status

Sanofi-Aventis Investigational Site Number 320704

Guatemala City, , Guatemala

Site Status

Sanofi-Aventis Investigational Site Number 356701

Bangalore, , India

Site Status

Sanofi-Aventis Investigational Site Number 356703

Bangalore, , India

Site Status

Sanofi-Aventis Investigational Site Number 356702

Hyderabad, , India

Site Status

Sanofi-Aventis Investigational Site Number 356704

Nagpur, , India

Site Status

Sanofi-Aventis Investigational Site Number 484703

Mérida, , Mexico

Site Status

Sanofi-Aventis Investigational Site Number 484701

Tlalnepantla, , Mexico

Site Status

Sanofi-Aventis Investigational Site Number 484704

Zapopan, , Mexico

Site Status

Sanofi-Aventis Investigational Site Number 604703

Lima, , Peru

Site Status

Sanofi-Aventis Investigational Site Number 604701

Lima, , Peru

Site Status

Sanofi-Aventis Investigational Site Number 604702

Lima, , Peru

Site Status

Sanofi-Aventis Investigational Site Number 604705

Lima, , Peru

Site Status

Sanofi-Aventis Investigational Site Number 630714

Carolina, , Puerto Rico

Site Status

Sanofi-Aventis Investigational Site Number 630715

Carolina, , Puerto Rico

Site Status

Sanofi-Aventis Investigational Site Number 642711

Alba Iulia, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642702

Bacau, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642709

Baia Mare, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642701

Brasov, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642712

Bucharest, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642714

Bucharest, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642705

Constanța, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642707

Galati, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642703

Ploieşti, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642713

Reşiţa, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642708

Satu Mare, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642706

Târgu Mureş, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642715

Timișoara, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 642710

Timișoara, , Romania

Site Status

Sanofi-Aventis Investigational Site Number 792702

Erzurum, , Turkey (Türkiye)

Site Status

Sanofi-Aventis Investigational Site Number 792705

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Austria Canada France Germany Greece Guatemala India Mexico Peru Puerto Rico Romania Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013 Nov;15(11):1000-7. doi: 10.1111/dom.12121. Epub 2013 May 26.

Reference Type RESULT
PMID: 23627775 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT: 2007-005884-92

Identifier Type: -

Identifier Source: secondary_id

EFC6017

Identifier Type: -

Identifier Source: org_study_id