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Type 1 Diabetes MellitusPhase 3NCT00920582

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

A Phase 3 study testing Teplizumab Herold Regimen, Teplizumab 33.3% Herold Regimen and Teplizumab Curtailed Herold Regimen in people with Type 1 Diabetes Mellitus, run by MacroGenics at 118 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes. Read more about this study

Who is it for?
Ages 8 to 35 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Teplizumab Herold Regimen, Teplizumab 33.3% Herold Regimen and Teplizumab Curtailed Herold Regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
254 participants
Where
118 sitesin 16 countries
Study dates
Sep 2009to Jul 2012
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 8 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Subjects 8-35 years old
  • Body weight > 36 Kg
  • Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria
  • Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes
  • Requires insulin for T1DM or has required insulin at some time between diagnosis and administration of study drug
  • Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable range of the assay) at screening
Show all 10Show fewer
  • Diagnosis of T1DM as evidenced by one positive result on testing for any of the following antibodies at screening:
  • Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
  • Glutamic acid decarboxylase (GAD) autoantibodies, or
  • Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive).

Who cannot join

  • Prior administration of a monoclonal antibody-within the 1 year before randomization
  • Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
  • Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
  • Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
  • Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
  • Current treatment with oral antidiabetic agents
Show all 11Show fewer
  • Evidence of active or latent tuberculosis
  • Vaccination with a live virus or organism within the 8 weeks before randomization continuing through Week 52 of the study.
  • Influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle.
  • Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle
  • Any infectious mononucleosis-like illness within the 6 months before randomization

Trial locations and contacts

118 sites in 16 countries.

118 sites in 16 countries

United States42 sites

  • Albany Medical College

    Albany, New York, 12208

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30309

  • St. Agnes Hospital

    Baltimore, Maryland, 21229

  • AM Diabetes & Endocrinology Center

    Bartlett, Tennessee, 38133

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37403

  • John H Stoger Jr. Hospital of Cook County, Cook County Hospital

    Chicago, Illinois, 60612

  • University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology

    Columbia, Missouri, 65212

  • Bassett Healthcare

    Cooperstown, New York, 13326

  • Clinical Innovations Inc. Research Facility

    Costa Mesa, California, 92626

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Alzohaili Medical Consultants

    Dearborn, Michigan, 48126

  • East Carolina University, Brody School of Medicine

    Greenville, North Carolina, 27834

  • GHS Pediatric Endocrinology

    Greenville, South Carolina, 29615

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Houston Center for Clinical Research

    Houston, Texas, 77081

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • University of Iowa Children's Hospital

    Iowa City, Iowa, 52242-1083

  • Medical & Surgical Clinic of Irving

    Irving, Texas, 75061

  • NEA Clinic

    Jonesboro, Arkansas, 72401

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72272

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • LeBonheur Children's Medical Center

    Memphis, Tennessee, 38103

  • Yale University

    New Haven, Connecticut, 06519

  • Christiana Care Research Institute

    Newark, Delaware, 19713

  • Endocrine Research Specialists

    Ogden, Utah, 84403

  • Diabetes Associates Medical Group, Inc

    Orange, California, 92868

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism

    Richmond, Virginia, 23219

  • Clinical Innovations, Inc.

    Riverside, California, 92506

  • Maryland Diabetes & Endocrine Associates

    Rockville, Maryland, 20852

  • Children's Hospitals and Clinics of Minnesota

    Saint Paul, Minnesota, 55102

  • InVisions Consultants, LLC

    San Antonio, Texas, 78217

  • Diabetes and Glandular Disease Research Associates, PA

    San Antonio, Texas, 78229

  • San Diego Clinical Trials

    San Diego, California, 92120

  • University of Washington

    Seattle, Washington, 98122

  • Ronald Chochinov Md Inc

    Ventura, California, 93003

  • Richard Hays, MD

    Wellington, Florida, 33414

  • Mid-America Diabetes Associates

    Wichita, Kansas, 67211

Other trials in United States

India16 sites

  • DHL Research Centre

    Ahmedabad, Gujarat, 380015

  • Bangalore Diabetes Centre

    Bangalore, Karnataka, 560043

  • Kalinga Hospital Limited

    Bhubaneswar, Odisha, 751023

  • Hormone Care & Research Center

    Ghaziabad, Uttar Pradesh, 201002

  • Medwin Hospitals

    Hyderabad, Andhra Pradesh, 500001

  • Fortis Escorts Hospital

    Jaipur, Rajasthan, 302017

  • B. P. Poddar Hospital & Medical Research Limited

    Kolkata, West Bengal, 700053

  • Apollo Glenagles Hospital

    Kolkata, West Bengal, 700054

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001

  • Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd.

    Madhya, Pradesh, 452001

  • Gandhi's Research Institute

    Nagpur, Maharashtra, 440010

  • Maulana Azad Medical College and Associated Hospitals

    New Delhi, National Capital Territory of Delhi, 110002

  • Grant Medical Foundation

    Pune, Maharashtra, 411001

  • KEM Hospital Research Center

    Pune, Maharashtra, 411011

  • Health & Research Centre

    Trivandrum, Kerala, 695011

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Germany8 sites

  • Diabetes-Klinik Bad Nauheim GmbH

    Bad Nauheim, 61231

  • Herz und Diabeteszentrum Nordrhein-Westfallen

    Bad Oeynhausen, 32545

  • Charite, Campus Benjamin Franklin

    Berlin, 12200

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 20225

  • Universitatsklinik Giessen

    Giessen, 35392

  • Asklepios Westklinikum Hamburg

    Hamburg, 22559

  • Kinderkrankenhaus auf der Bult

    Hanover, 30173

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

Other trials in Germany

Ukraine7 sites

  • Donetsk Regional Children Clinical Hospital

    Donetsk, 83052

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • Ivano-Frankivsk State Regional Pediatric Clinical Hospital

    Ivano-Frankivsk, 76014

  • Kharkiv Regional Clinical Children Hospital, Department of Endocrinology

    Kharkiv, 61093

  • Ukrainian Children Specialized Clinical Hospital

    Kyiv, 01135

  • Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine

    Kyiv, 04114

  • Regional Clinical Endocrinology Dispensary of MoH Ukraine

    Vinnitsa, 21010

Other trials in Ukraine

France6 sites

  • CHU de Besançon

    Besançon, 25030

  • CHU de Brest Hôpital de la Cavale Blanche

    Brest, 29609

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

  • CHU de Bordeaux

    Pessac, 33604

  • CHU de Reims

    Reims, 51092

  • Hôpitaux Universitaires de Strasbourg Hôpital Civil

    Strasbourg, 67091

Other trials in France

Poland6 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Wojewódzki Specjalistyczny Szpital Dzieciecy

    Kielce, 25-734

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4

    Lodz, 91-738

  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia

    Warsaw, 01-184

  • Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu

    Wroclaw, 50-376

Other trials in Poland

United Kingdom6 sites

  • University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,

    Bristol, BS1 3NY

  • Aintree University Hospitals NHS Foundation Trust

    Liverpool, L9 7AL

  • Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology

    London, SE1 9RT

  • Queens Medical Centre, Diabetes and Endocrinology Unit

    Nottingham, NG7 2UH

  • George Eliot Hospital NHS Trust

    Nuneaton, Warwickshire, CV10 7DJ

  • Sheffield Children's Hospital NHS Foundation Trust

    Sheffield, S10 2IH

Other trials in United Kingdom

Czechia5 sites

  • I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice

    Brno, 62500

  • Klinika deti a dorostu FN Kralovske Vinohrady

    Prague, 10034

  • Centrum diabetologie, Institut klinicke a experimentalni mediciny

    Prague, 14021

  • Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole

    Prague, 15006

  • Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z.

    Ústí nad Labem, 40113

Other trials in Czechia

Israel5 sites

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Mayer Children's Hospital of Haifa

    Haifa, 31096

  • The E. Wolfson Medical Center

    Holon, 58100

  • Schneider Children's Medical

    Petah Tikva, 49202

  • The Safra Children's Hospital, The Chaim Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

Finland3 sites

  • Kuopio University Hospital

    Kuopio, 70210

  • Central Hospital of Mikkeli

    Mikkeli, 50100

  • Oulu University Hospital

    Oulu, 90029

Other trials in Finland

Italy3 sites

  • Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,

    Modena, 41124

  • U.O. di Malattie del Metabolismo

    Pisa, 16132

  • U.O. di Malattie Metaboliche e Diabetologia

    Pisa, 56124

Other trials in Italy

Mexico3 sites

  • Medical Care & Research

    Mérida, Yucatán, 97070

  • Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.

    Mexico City, 11650

  • Hospital y Clinica OCA / Monterrey International Research Center

    Monterrey, Nuevo León, 64000

Other trials in Mexico

Romania3 sites

  • S.C. Minimed S.R.L.

    Bacau, 600164

  • Institutul National De Diabet, Nutritie si Boli Metabolice

    Bucharest, 020045

  • Spitalul Judetean de Urgenta Satu Mare

    Satu Mare, 440055

Other trials in Romania

Belgium2 sites

  • Cliniques du Sud Luxembourg - Vivalia

    Arlon, 6700

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerp, 2650

Other trials in Belgium

Spain2 sites

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, 28805

  • Hospital Dr. Josep Trueta

    Girona, 17007

Other trials in Spain

Netherlands1 site

  • Stichting Diabeter

    Rotterdam, 3011 TG

Other trials in Netherlands

About this study

Official title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

Being tested
Teplizumab Herold Regimen, Placebo, Teplizumab 33.3% Herold Regimen, Teplizumab Curtailed Herold Regimen
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teplizumab Herold RegimenBiological

    Also called MGA031

    Full dose of teplizumab IV for 14 days, repeated at Week 26

  • PlaceboDrug

    IV dosing daily for 14 days repeated at Week 26

  • Teplizumab 33.3% Herold RegimenBiological

    Also called MGA031

    One third full dose of teplizumab IV for 14 days, repeated at Week 26

  • Teplizumab Curtailed Herold RegimenBiological

    Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26

Study groups in NCT00920582
Study groupRoleWhat they receive
Herold RegimenExperimental14-day cycle of teplizumab consisting of daily IV doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, and 413 µg/m2 on Study Days 1-4, respectively, and one dose of 826 µg/m2 on each of Study Days 5-14. Repeat at Week 26
Receives: Biological: Teplizumab Herold Regimen
33.3% Herold RegimenExperimentalSubjects received a 14-day cycle of teplizumab consisting of daily IV doses of 17 µg/m2, 34 µg/m2, 68 µg/m2, and 136 µg/m2 on Study Days 1-4, respectively, and one dose of 273 µg/m2 on each of Study Days 5-14. Repeat at Week 26
Receives: Biological: Teplizumab 33.3% Herold Regimen
Curtailed Herold RegimenExperimentalSubjects received a 6 day cycle of teplizumab consisting of daily IV doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, and 413 µg/m2 on Study Days 1-4, respectively, and one dose of 826 µg/m2 on each of Study Days 5-6, followed by 8 days of IV placebo (Study Days 7-14). Repeat at Week 26
Receives: Biological: Teplizumab Curtailed Herold Regimen
PlaceboPlacebo comparator14-day cycle of placebo consisting of daily IV doses. Repeat at Week 26
Receives: Drug: Placebo

What is being measured

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

  1. Proportion of Subjects With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.

    Measured: 52 weeks after randomization

  2. Mean Change From Baseline in HbA1c Between Teplizumab and Placebo

    Measured: 52 weeks after randomization

Secondary outcomes (9)

  1. The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal

    Measured: 52 weeks after randomization

  2. The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal

    Measured: 104 weeks after randomization

  3. Mean Number of Total, Major, Minor and Nocturnal Hypoglycemia Events

    Number of hypoglycemic events by type per participant

    Measured: Throughout the study up to 2 years

  4. Mean Number of Daily Insulin Injections

    Measured: 52 weeks after randomization

  5. Number of Subjects With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.

    Measured: 104 weeks after randomization

  6. The Proportion of Subjects Who Have Both a Total Daily Insulin Dose < 0.5 U/Kg/Day and Hemoglobin A1c (HbA1c) Level < 7.0%

    Measured: 52 weeks after randomization

  7. The Mean HbA1c Change From Baseline

    Measured: 104 weeks after randomization

  8. Number of Participants With Adverse Events

    Measured: throughout the study, up to 104 weeks

  9. Number of Participants With Serious Adverse Events

    Measured: throughout the study, up to 104 weeks

Timeline

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

  1. First posted15 Jun 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionApr 2012
  4. Study completionJul 2012

Why it stopped: Business decision

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00920582
Sponsor's protocol ID
CP-MGA031-03
Status last verified
Oct 2023
First submitted
12 Jun 2009
Last updated
20 Dec 2023
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teplizumab Herold Regimen, Teplizumab 33.3% Herold Regimen and Teplizumab Curtailed Herold Regimen in people with Type 1 Diabetes Mellitus, run by MacroGenics at 118 sites in 16 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, India, Germany, Ukraine, France and 11 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. 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 20 Dec 2023). 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?

Proportion of Subjects With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. (time frame: 52 weeks after randomization). The study lists 2 primary outcomes in all. 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 NCT00920582.

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 Dec 2023.

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