Type 1 Diabetes MellitusPhase 3DIA-AID2NCT01103284
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
A Phase 3 study testing DiaPep277 in people with Type 1 Diabetes Mellitus, run by Andromeda Biotech Ltd. at 75 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- DiaPep277
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 475 participants
- Where
- 75 sitesin 14 countries
- Study dates
- Apr 2010to Oct 2014
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of type 1 diabetes within last 6 months
- Age 20-45 years
- fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
- BMI between 17 and 30 at screening
Who cannot join
- Significant disease or condition other than type 1 diabetes
- Diabetes-related complications
- Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids
Trial locations and contacts
75 sites in 14 countries.
75 sites in 14 countries
United States26 sites
Mountain Diabetes and Endocrine Center
Ashville, North Carolina, 28803
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
University of Colorado Hospital - Anschutz Outpatient Pavilion
Aurora, Colorado, 80045
Innovative Medical Research of South Florida Inc.
Aventura, Florida, 33180
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133
The Lindner Research Center, The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Research Institute of Dallas
Dallas, Texas, 75231
Study site
DeLand, Florida, 32720
Creekside Endocrine Associates, Inc.
Denver, Colorado, 80209
University of North Carolina Diabetes Care Center
Durham, North Carolina, 27703
Palm Medical Research Center
Las Vegas, Nevada, 89148
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503
Study site
Los Gatos, California, 95032
Sutter Gold Medical Foundation
Modesto, California, 95355
Orlando Diabetes & Endocrine Specialists, P.A.
Orlando, Florida, 32825
Legacy Clinical Research & Technology Center
Portland, Oregon, 97210
Cetero Research
San Antonio, Texas, 78229
San Diego Clinical Trials
San Diego, California, 92120
Soutwest Clinical Research Center, LLC
Santa Fe, New Mexico, 87505
Northside Internal Medicine Associates, PS
Spokane, Washington, 99208
Washington University
St Louis, Missouri, 63110
Multicare Specialties Research
Tacoma, Washington, 98405
Tallahassee Endocrine Associates
Tallahassee, Florida, 32308
Diabetes and Hormonal Disease Center
Tampa, Florida, 33613
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Russia12 sites
State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical
Chelyabinsk, 454021
Kemerovo Regional Clinical Hospital
Kemerovo, 650066
Endocrinological scientific center of Rosmedtechnology
Moscow, 117036
SEIAPE Endocrinology and Diabetology
Moscow, 125367
City Clinical Hospital #81, Endocrinology Department
Moscow, 127644
Clinic of New Medical Technology, LLC
Moscow, 140091
State Healthcare Institution (SHI) "Nizhegorodskaya
Nizhny Novgorod, 603126
State Healthcare Institution Perm Region Clinical Hospital
Perm, 614990
St. Petersburg State Healthcare Institution
Saint Petersburg, 194354
State Educational Institution of Higher Professional Education
Saint Petersburg, 197022
Limited Liability Company (LLC), Diabetes Center
Samara, 443067
Siberian State Medical University of Roszdrav
Tomsk, 634050
Israel6 sites
Diabetes Clinic Soroka University
Beersheba, 84101
Soroka University Medical Center
Beersheba, 84101
Rambam Medical Cent
Haifa, 31096
Wolfson Medical Center
Holon
Hadassah Medical Center
Jerusalem
Institute for Endocrinology and Diabetes Schneider Children's MC
Petach-Tiqva, 49202
Belarus5 sites
Endocrinological Unit 1st City Clinical Hospital
Minsk, 220013
Republican center of Medical Rehabilitation and Balneotherapy
Minsk, 220013
Health Institution City Endocrinological Dispensary
Minsk, 220029
Belarusian Medical Academy of Postgraduate Education
Minsk, 220096
Health Institution Mogilev Diagnostic Center
Mogilev, 212030
Germany5 sites
DDZ Studienzentrum Deutsches Diabetes Zentrum
Düsseldorf, 40225
Universitatsklinikum Giessen
Giessen, 35392
Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult
Hanover, 30173
Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin
München, 80804
Institut für Diabetesforschung Münster GmbH
Münster, 48145
Lithuania4 sites
Private Clinic JSC 'Kristavita'
Jonava, 55201
Kaunas Medical University Hospital
Kaunas, 50009
Public Institution 'Seskines Outpatient Clinic'
Vilnius, 07156
Vilnius Medical University Hospital, Santariskiu Clinic's
Vilnius, 08661
Canada3 sites
LMC Endocrinology Centres
Calgary, Alberta, T2H 0K2
LMC Endocrinology Centres
Oakville, Ontario, L6H 3P1
LMC Endocrinoly Centres
Toronto, Ontario, M4R 2G4
Hungary3 sites
University of Szeged Faculty of Medicin
Szeged, H-6700
Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum
Veszprém, 8200
Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum
Zalaegerszeg, 9000
Italy3 sites
. Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm
Palermo, 90127
Dept. of Endocrinology and Diabetes University Campus Bio-Medico
Rome, 00128
University La Sapienza, Policlinico Umberto I
Rome, 00161
Austria2 sites
Universitatsklinik fur Innere Medzin I, Landeskrankenhaus
Innsbruck, 6020
Rudolfstiftung Hospital
Vienna, 1030
Czechia2 sites
Fakultni nemocnice Kralovske Vinohrady - II. internal department
Prague, 10035
IKEM/Diabetes Centre/Videnska
Prague, 4140
Spain2 sites
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, 35016
Hospital Universitari Arnau de Vilanova
Lleida, 25198
About this study
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
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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- DiaPep277, Placebo
- Keywords
- beta-cells, autoimmune, Diabetes, immunomodulation
- 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.
DiaPep277Drug
1.0 mg dose in 0.5 mL of solution
PlaceboDrug
40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
| Study group | Role | What they receive |
|---|---|---|
| DiaPep277 | Experimental | Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations. Receives: Drug: DiaPep277 |
| Placebo | Placebo comparator | Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months
Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
Measured: Baseline and 24 months
Secondary outcomes (3)
Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%
The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.
Measured: 24 and 25 months
Frequency of Hypoglycemic Events
Total number of days with at least one hypoglycemic event recorded
Measured: Baseline to 25 Months
Mean Number of Days With at Least One Hypoglycemic Event
Measured: Baseline to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andromeda Biotech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Itamar Raz, MD, Principal investigator, Hadassah Medical Center, JerusalemThomas Linn, MD, Principal investigator, University of GiessenPaolo P Pozzilli, MB, BS, MD, Principal investigator, University Campus Bio-Medico, RomePhilip Raskin, MD, Principal investigator, UT Southwestern Medical Center, Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103284
- Sponsor's protocol ID
- DiaPep277-1001
- Acronym
- DIA-AID2
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2010
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Huurman VA, van der Meide PE, Duinkerken G, Willemen S, Cohen IR, Elias D, Roep BO. Immunological efficacy of heat shock protein 60 peptide DiaPep277 therapy in clinical type I diabetes. Clin Exp Immunol. 2008 Jun;152(3):488-97. doi: 10.1111/j.1365-2249.2008.03656.x. Epub 2008 Apr 16.
PubMed 18422727Huurman VA, Decochez K, Mathieu C, Cohen IR, Roep BO. Therapy with the hsp60 peptide DiaPep277 in C-peptide positive type 1 diabetes patients. Diabetes Metab Res Rev. 2007 May;23(4):269-75. doi: 10.1002/dmrr.691.
PubMed 17024692Schloot NC, Meierhoff G, Lengyel C, Vandorfi G, Takacs J, Panczel P, Barkai L, Madacsy L, Oroszlan T, Kovacs P, Suto G, Battelino T, Hosszufalusi N, Jermendy G. Effect of heat shock protein peptide DiaPep277 on beta-cell function in paediatric and adult patients with recent-onset diabetes mellitus type 1: two prospective, randomized, double-blind phase II trials. Diabetes Metab Res Rev. 2007 May;23(4):276-85. doi: 10.1002/dmrr.707.
PubMed 17103487Raz I, Avron A, Tamir M, Metzger M, Symer L, Eldor R, Cohen IR, Elias D. Treatment of new-onset type 1 diabetes with peptide DiaPep277 is safe and associated with preserved beta-cell function: extension of a randomized, double-blind, phase II trial. Diabetes Metab Res Rev. 2007 May;23(4):292-8. doi: 10.1002/dmrr.712.
PubMed 17124720Eldor R, Kassem S, Raz I. Immune modulation in type 1 diabetes mellitus using DiaPep277: a short review and update of recent clinical trial results. Diabetes Metab Res Rev. 2009 May;25(4):316-20. doi: 10.1002/dmrr.942.
PubMed 19267355Raz I, Elias D, Avron A, Tamir M, Metzger M, Cohen IR. Beta-cell function in new-onset type 1 diabetes and immunomodulation with a heat-shock protein peptide (DiaPep277): a randomised, double-blind, phase II trial. Lancet. 2001 Nov 24;358(9295):1749-53. doi: 10.1016/S0140-6736(01)06801-5.
PubMed 11734230Elias D, Avron A, Tamir M, Raz I. DiaPep277 preserves endogenous insulin production by immunomodulation in type 1 diabetes. Ann N Y Acad Sci. 2006 Oct;1079:340-4. doi: 10.1196/annals.1375.052.
PubMed 17130576Nussbaum G, Zanin-Zhorov A, Quintana F, Lider O, Cohen IR. Peptide p277 of HSP60 signals T cells: inhibition of inflammatory chemotaxis. Int Immunol. 2006 Oct;18(10):1413-9. doi: 10.1093/intimm/dxl074. Epub 2006 Aug 7.
PubMed 16893923Fischer B, Elias D, Bretzel RG, Linn T. Immunomodulation with heat shock protein DiaPep277 to preserve beta cell function in type 1 diabetes - an update. Expert Opin Biol Ther. 2010 Feb;10(2):265-72. doi: 10.1517/14712590903555176.
PubMed 20034363
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01103284
- Acronym / sponsor ID
- DIA-AID2 / DiaPep277-1001
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- beta-cells, autoimmune, Diabetes, immunomodulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Andromeda Biotech Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Apr 2010 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DiaPep277 | Experimental | Drug: DiaPep277Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations. |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- clinical diagnosis of type 1 diabetes within last 6 months
- Age 20-45 years
- fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
- BMI between 17 and 30 at screening
Key exclusion criteria (3 listed)
- Significant disease or condition other than type 1 diabetes
- Diabetes-related complications
- Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaPep2771.0 mg dose in 0.5 mL of solution | Drug | DiaPep277 |
| Placebo40 mg mannitol in 0.5 mL of solution. Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months | Drug | Placebo |
Primary outcome
Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months
Time frame: Baseline and 24 months
Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
3 secondary outcomes
Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%
Time frame: 24 and 25 months
Frequency of Hypoglycemic Events
Time frame: Baseline to 25 Months
Mean Number of Days With at Least One Hypoglycemic Event
Time frame: Baseline to 25 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18422727Huurman VA, van der Meide PE, Duinkerken G, Willemen S, Cohen IR, Elias D, Roep BO. Immunological efficacy of heat shock protein 60 peptide DiaPep277 therapy in clinical type I diabetes. Clin Exp Immunol. 2008 Jun;152(3):488-97. doi: 10.1111/j.1365-2249.2008.03656.x. Epub 2008 Apr 16.
- Background: PubMed 17024692Huurman VA, Decochez K, Mathieu C, Cohen IR, Roep BO. Therapy with the hsp60 peptide DiaPep277 in C-peptide positive type 1 diabetes patients. Diabetes Metab Res Rev. 2007 May;23(4):269-75. doi: 10.1002/dmrr.691.
- Background: PubMed 17103487Schloot NC, Meierhoff G, Lengyel C, Vandorfi G, Takacs J, Panczel P, Barkai L, Madacsy L, Oroszlan T, Kovacs P, Suto G, Battelino T, Hosszufalusi N, Jermendy G. Effect of heat shock protein peptide DiaPep277 on beta-cell function in paediatric and adult patients with recent-onset diabetes mellitus type 1: two prospective, randomized, double-blind phase II trials. Diabetes Metab Res Rev. 2007 May;23(4):276-85. doi: 10.1002/dmrr.707.
- Background: PubMed 17124720Raz I, Avron A, Tamir M, Metzger M, Symer L, Eldor R, Cohen IR, Elias D. Treatment of new-onset type 1 diabetes with peptide DiaPep277 is safe and associated with preserved beta-cell function: extension of a randomized, double-blind, phase II trial. Diabetes Metab Res Rev. 2007 May;23(4):292-8. doi: 10.1002/dmrr.712.
- Background: PubMed 19267355Eldor R, Kassem S, Raz I. Immune modulation in type 1 diabetes mellitus using DiaPep277: a short review and update of recent clinical trial results. Diabetes Metab Res Rev. 2009 May;25(4):316-20. doi: 10.1002/dmrr.942.
- Background: PubMed 11734230Raz I, Elias D, Avron A, Tamir M, Metzger M, Cohen IR. Beta-cell function in new-onset type 1 diabetes and immunomodulation with a heat-shock protein peptide (DiaPep277): a randomised, double-blind, phase II trial. Lancet. 2001 Nov 24;358(9295):1749-53. doi: 10.1016/S0140-6736(01)06801-5.
- Background: PubMed 17130576Elias D, Avron A, Tamir M, Raz I. DiaPep277 preserves endogenous insulin production by immunomodulation in type 1 diabetes. Ann N Y Acad Sci. 2006 Oct;1079:340-4. doi: 10.1196/annals.1375.052.
- Background: PubMed 16893923Nussbaum G, Zanin-Zhorov A, Quintana F, Lider O, Cohen IR. Peptide p277 of HSP60 signals T cells: inhibition of inflammatory chemotaxis. Int Immunol. 2006 Oct;18(10):1413-9. doi: 10.1093/intimm/dxl074. Epub 2006 Aug 7.
- Background: PubMed 20034363Fischer B, Elias D, Bretzel RG, Linn T. Immunomodulation with heat shock protein DiaPep277 to preserve beta cell function in type 1 diabetes - an update. Expert Opin Biol Ther. 2010 Feb;10(2):265-72. doi: 10.1517/14712590903555176.
- the Sponsor site, with specific information on DiaPep277 mode of actionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itamar Raz, MD principal investigator
Hadassah Medical Center, Jerusalem
Thomas Linn, MD principal investigator
University of Giessen
Paolo P Pozzilli, MB, BS, MD principal investigator
University Campus Bio-Medico, Rome
75 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DiaPep277 in people with Type 1 Diabetes Mellitus, run by Andromeda Biotech Ltd. at 75 sites in 14 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 4 inclusion and 3 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Russia, Israel, Belarus, Germany and 9 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 26 May 2016). 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?
Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months (time frame: Baseline and 24 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 NCT01103284, which also lists 9 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 26 May 2016.