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Type 1 Diabetes MellitusPhase 3NCT00751842

A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT

A Phase 3 study testing rhGAD65 in people with Type 1 Diabetes Mellitus, run by Diamyd Therapeutics AB at 43 sites in United States.

Terminated

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

Official record
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Trial summary

The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes. Read more about this study

Who is it for?
Ages 10 to 20 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
rhGAD65
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
331 participants
Where
43 sitesUnited States
Study dates
Sep 2008to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

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 10 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Main Inclusion Criteria:

  • Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
  • Fasting C-peptide level at time of screening above 0.1 nmol/L
  • Elevated GAD65 antibodies (GADA) at time of screening
  • Male and female patients between 10 and 20 years of age

Main Exclusion Criteria:

  • Treatment with immunosuppressants or any anti-diabetic medications other than insulin
  • A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
  • Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
  • Participation in other clinical trials with a new chemical entity within the previous 3 months
  • Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
  • Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30309

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Alzohaili Medical Consultants

    Dearborn, Michigan, 48126

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • University of Florida

    Gainsville, Florida, 32610

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • University of Iowa Hospitals and Clinicals

    Iowa City, Iowa, 52242

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • University of Kentucky College of Medicine

    Lexington, Kentucky, 40536

  • Arkansas Children's Hospital Research Institute

    Little Rock, Arkansas, 72202

  • University of Louisville Research Foundation

    Louisville, Kentucky, 40202

  • LeBonheur Children's Medical Center

    Memphis, Tennessee, 38103

  • Miami Children's Hospital Research Institute

    Miami, Florida, 33155

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Children's Hospital

    New Orleans, Louisiana, 70118

  • Naomi Berrie Diabetes Center of Columbia University

    New York, New York, 10032

  • Christina Care Research institute

    Newark, Delaware, 19713

  • Creighton Diabetes Center

    Omaha, Nebraska, 68131

  • Children's Hospital Orange County

    Orange, California, 92868

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

  • Regional Medical Clinic - Endocrinology

    Rapid City, South Dakota, 57701

  • Kathryn Eckert

    Reno, Nevada, 89502

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • University of Rochester

    Rochester, New York, 14642

  • Alex Endocrine Associates

    Rogers, Arkansas, 72758

  • CHRISTUS Santa Rosa Children's Hospital

    San Antonio, Texas, 78207

  • Rady Children's Hospital

    San Diego, California, 92123

  • Benaroya Research Institute

    Seattle, Washington, 98101

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • SUNY Institute for Human Performance

    Syracuse, New York, 13210

  • University of South Florida

    Tampa, Florida, 33606

  • University of Arizona

    Tucson, Arizona, 85724

  • University of Oklahoma, Schustermann Center Clinic

    Tulsa, Oklahoma, 74135

  • Mid America Diabetes Associates

    Wichita, Kansas, 67211

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (USA)

The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.

Being tested
rhGAD65, Placebo
Keywords
Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, Diamyd, rhGAD65, GAD, GAD-alum
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

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

  • rhGAD65Drug

    Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.

  • rhGAD65Drug

    Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.

  • PlaceboDrug

    Placebo injected subcutaneously at days 1, 30, 90 and 270.

Study groups in NCT00751842
Study groupRoleWhat they receive
AActive comparatorThis arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on days 90 and 270.
Receives: Drug: rhGAD65
BActive comparatorThis arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on days 90 and 270.
Receives: Drug: rhGAD65
CPlacebo comparatorThis arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270.
Receives: Drug: Placebo

What is being measured

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

  1. Meal Stimulated C-peptide (area under the curve)

    Measured: 15 months

Secondary outcomes (2)

  1. HbA1c

    Measured: 15 months

  2. Insulin Dose

    Measured: 15 months

Timeline

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

  1. First posted12 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2012
  4. Study completionJul 2012

Why it stopped: Based on other clinical trial results it was unlikely the study would meet the efficacy endpoints

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
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00751842
Sponsor's protocol ID
D/P3/07/5
Status last verified
Oct 2012
First submitted
11 Sep 2008
Last updated
10 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Ludvigsson J, Faresjo M, Hjorth M, Axelsson S, Cheramy M, Pihl M, Vaarala O, Forsander G, Ivarsson S, Johansson C, Lindh A, Nilsson NO, Aman J, Ortqvist E, Zerhouni P, Casas R. GAD treatment and insulin secretion in recent-onset type 1 diabetes. N Engl J Med. 2008 Oct 30;359(18):1909-20. doi: 10.1056/NEJMoa0804328. Epub 2008 Oct 8.

    PubMed 18843118

  • Ludvigsson J, Krisky D, Casas R, Battelino T, Castano L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Aman J, Kardell G, Neiderud Helsingborg J, Lundstrom G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanas R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NO, Akesson CG, Keskinen P, Veijola R, Talvitie T, Raile K, Kapellen T, Burger W, Neu A, Engelsberger I, Heidtmann B, Bechtold S, Leslie D, Chiarelli F, Cicognani A, Chiumello G, Cerutti F, Zuccotti GV, Gomez Gila A, Rica I, Barrio R, Clemente M, Lopez Garcia MJ, Rodriguez M, Gonzalez I, Lopez JP, Oyarzabal M, Reeser HM, Nuboer R, Stouthart P, Bratina N, Bratanic N, de Kerdanet M, Weill J, Ser N, Barat P, Bertrand AM, Carel JC, Reynaud R, Coutant R, Baron S. GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. N Engl J Med. 2012 Feb 2;366(5):433-42. doi: 10.1056/NEJMoa1107096.

    PubMed 22296077

  • Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Palmer JP, Raskin P, Rodriguez H, Schatz D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet GAD Study Group. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial. Lancet. 2011 Jul 23;378(9788):319-27. doi: 10.1016/S0140-6736(11)60895-7. Epub 2011 Jun 27.

    PubMed 21714999

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhGAD65 in people with Type 1 Diabetes Mellitus, run by Diamyd Therapeutics AB at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. 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?

The study was stopped early (reason given: Based on other clinical trial results it was unlikely the study would meet the efficacy endpoints). Results are not available in the source record.

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?

Meal Stimulated C-peptide (area under the curve) (time frame: 15 months). 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 NCT00751842, which also lists 3 linked publications.

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 10 Oct 2012.

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