Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
Public ClinicalTrials.gov record NCT01103284. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical Efficacy and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells. Adults (\>20 years) with newly diagnosed (\<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
Study identification
- NCT ID
- NCT01103284
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 475 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 20 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2010 (Type not available)
- Primary completion
- Oct 2014 (Actual)
- Completion
- Oct 2014 (Actual)
- Last update posted
- May 26, 2016
2010 – 2014
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Los Gatos | California | 95032 | — |
| Sutter Gold Medical Foundation | Modesto | California | 95355 | — |
| San Diego Clinical Trials | San Diego | California | 92120 | — |
| University of Colorado Hospital - Anschutz Outpatient Pavilion | Aurora | Colorado | 80045 | — |
| Creekside Endocrine Associates, Inc. | Denver | Colorado | 80209 | — |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Innovative Medical Research of South Florida Inc. | Aventura | Florida | 33180 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Orlando Diabetes & Endocrine Specialists, P.A. | Orlando | Florida | 32825 | — |
| Tallahassee Endocrine Associates | Tallahassee | Florida | 32308 | — |
| Diabetes and Hormonal Disease Center | Tampa | Florida | 33613 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | — |
| Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | 40503 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Palm Medical Research Center | Las Vegas | Nevada | 89148 | — |
| Soutwest Clinical Research Center, LLC | Santa Fe | New Mexico | 87505 | — |
| Mountain Diabetes and Endocrine Center | Ashville | North Carolina | 28803 | — |
| University of North Carolina Diabetes Care Center | Durham | North Carolina | 27703 | — |
| The Lindner Research Center, The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Legacy Clinical Research & Technology Center | Portland | Oregon | 97210 | — |
| AM Diabetes & Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| Research Institute of Dallas | Dallas | Texas | 75231 | — |
| Cetero Research | San Antonio | Texas | 78229 | — |
| Northside Internal Medicine Associates, PS | Spokane | Washington | 99208 | — |
| Multicare Specialties Research | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01103284, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 26, 2016 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01103284 live on ClinicalTrials.gov.