Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DiaPep277 | Drug | 1.0 mg dose in 0.5 mL of solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 and 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study | Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose 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 a daily insulin dose ≤ 0.5 IU/kg at study end. | 24 and 25 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Itamar Raz, MD | Hadassah Medical Center, Jerusalem | Principal Investigator |
| Thomas Linn, MD | University of Giessen | Principal Investigator |
| Paolo P Pozzilli, MB, BS, MD | University Campus Bio-Medico, Rome | Principal Investigator |
| Philip Raskin, MD | UT Southwestern Medical Center, Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Gatos | California | 95032 | United States | |||
| Sutter Gold Medical Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18422727 | Background | 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. | |
| 17024692 | Background |
Not provided
Not provided
Not provided
Patients newly diagnosed with Type 1 diabetes were recruited at medical centers in the US, EU, Argentina, and Israel.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DiaPep277 | 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. DiaPep277: 1.0 mg dose in 0.5 mL of solution |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
40 mg mannitol in 0.5 mL of solution. Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months |
|
| Frequency of Hypoglycemic Events | Total number of days with at least one hypoglycemic event recorded | Baseline to 25 Months |
| Mean Number of Days With at Least One Hypoglycemic Event | Baseline to 25 months |
| Modesto |
| California |
| 95355 |
| United States |
| San Diego Clinical Trials | San Diego | California | 92120 | United States |
| University of Colorado Hospital - Anschutz Outpatient Pavilion | Aurora | Colorado | 80045 | United States |
| Creekside Endocrine Associates, Inc. | Denver | Colorado | 80209 | United States |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Innovative Medical Research of South Florida Inc. | Aventura | Florida | 33180 | United States |
| DeLand | Florida | 32720 | United States |
| Orlando Diabetes & Endocrine Specialists, P.A. | Orlando | Florida | 32825 | United States |
| Tallahassee Endocrine Associates | Tallahassee | Florida | 32308 | United States |
| Diabetes and Hormonal Disease Center | Tampa | Florida | 33613 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States |
| Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | 40503 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Palm Medical Research Center | Las Vegas | Nevada | 89148 | United States |
| Soutwest Clinical Research Center, LLC | Santa Fe | New Mexico | 87505 | United States |
| Mountain Diabetes and Endocrine Center | Ashville | North Carolina | 28803 | United States |
| University of North Carolina Diabetes Care Center | Durham | North Carolina | 27703 | United States |
| The Lindner Research Center, The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Legacy Clinical Research & Technology Center | Portland | Oregon | 97210 | United States |
| AM Diabetes & Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Research Institute of Dallas | Dallas | Texas | 75231 | United States |
| Cetero Research | San Antonio | Texas | 78229 | United States |
| Northside Internal Medicine Associates, PS | Spokane | Washington | 99208 | United States |
| Multicare Specialties Research | Tacoma | Washington | 98405 | United States |
| Universitatsklinik fur Innere Medzin I, Landeskrankenhaus | Innsbruck | 6020 | Austria |
| Rudolfstiftung Hospital | Vienna | 1030 | Austria |
| Endocrinological Unit 1st City Clinical Hospital | Minsk | 220013 | Belarus |
| Republican center of Medical Rehabilitation and Balneotherapy | Minsk | 220013 | Belarus |
| Health Institution City Endocrinological Dispensary | Minsk | 220029 | Belarus |
| Belarusian Medical Academy of Postgraduate Education | Minsk | 220096 | Belarus |
| Health Institution Mogilev Diagnostic Center | Mogilev | 212030 | Belarus |
| LMC Endocrinology Centres | Calgary | Alberta | T2H 0K2 | Canada |
| LMC Endocrinology Centres | Oakville | Ontario | L6H 3P1 | Canada |
| LMC Endocrinoly Centres | Toronto | Ontario | M4R 2G4 | Canada |
| Fakultni nemocnice Kralovske Vinohrady - II. internal department | Prague | 10035 | Czechia |
| IKEM/Diabetes Centre/Videnska | Prague | 4140 | Czechia |
| Tutkimusyksikko | Oulu | 90220 | Finland |
| DDZ Studienzentrum Deutsches Diabetes Zentrum | Düsseldorf | 40225 | Germany |
| Universitatsklinikum Giessen | Giessen | 35392 | Germany |
| Diabetes Centre for Children and Adolescents, Kinderkrankenhaus auf der Bult | Hanover | 30173 | Germany |
| Institut für Diabetesforschung an der Klinik und Hochschulambulanz für Kinder- und Jugendmedizin | München | 80804 | Germany |
| Institut für Diabetesforschung Münster GmbH | Münster | 48145 | Germany |
| University of Szeged Faculty of Medicin | Szeged | H-6700 | Hungary |
| Veszprem Megyei Csolnoky Ferenc Korhaz es Rendelointezet Diabetologia Centrum | Veszprém | 8200 | Hungary |
| Zala Megyei Korhaz es Rendelointezet Diabetologia Centrum | Zalaegerszeg | 9000 | Hungary |
| Diabetes Clinic Soroka University | Beersheba | 84101 | Israel |
| Soroka University Medical Center | Beersheba | 84101 | Israel |
| Rambam Medical Cent | Haifa | 31096 | Israel |
| Wolfson Medical Center | Holon | Israel |
| Hadassah Medical Center | Jerusalem | Israel |
| Institute for Endocrinology and Diabetes Schneider Children's MC | Petach-Tiqva | 49202 | Israel |
| . Endocrinologia e Malattie Metaboliche, Dipartimento biomedico di medicina interna e specialistica, Ex Istituto di clinica medica, Università di Palerm | Palermo | 90127 | Italy |
| Dept. of Endocrinology and Diabetes University Campus Bio-Medico | Rome | 00128 | Italy |
| University La Sapienza, Policlinico Umberto I | Rome | 00161 | Italy |
| Private Clinic JSC 'Kristavita' | Jonava | 55201 | Lithuania |
| Kaunas Medical University Hospital | Kaunas | 50009 | Lithuania |
| Public Institution 'Seskines Outpatient Clinic' | Vilnius | 07156 | Lithuania |
| Vilnius Medical University Hospital, Santariskiu Clinic's | Vilnius | 08661 | Lithuania |
| NZOZ OmniMed | Lodz | 93-338 | Poland |
| State Educational Institution for Additional Professional Education (SEIAPE) "Ural State Medical | Chelyabinsk | 454021 | Russia |
| Kemerovo Regional Clinical Hospital | Kemerovo | 650066 | Russia |
| Endocrinological scientific center of Rosmedtechnology | Moscow | 117036 | Russia |
| SEIAPE Endocrinology and Diabetology | Moscow | 125367 | Russia |
| City Clinical Hospital #81, Endocrinology Department | Moscow | 127644 | Russia |
| Clinic of New Medical Technology, LLC | Moscow | 140091 | Russia |
| State Healthcare Institution (SHI) "Nizhegorodskaya | Nizhny Novgorod | 603126 | Russia |
| State Healthcare Institution Perm Region Clinical Hospital | Perm | 614990 | Russia |
| St. Petersburg State Healthcare Institution | Saint Petersburg | 194354 | Russia |
| State Educational Institution of Higher Professional Education | Saint Petersburg | 197022 | Russia |
| Limited Liability Company (LLC), Diabetes Center | Samara | 443067 | Russia |
| Siberian State Medical University of Roszdrav | Tomsk | 634050 | Russia |
| Complejo Hospitalario Universitario Insular Materno-Infantil | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Universitari Arnau de Vilanova | Lleida | 25198 | Spain |
| Huurman 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. |
| 17103487 | Background | Schloot 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. |
| 17124720 | Background | Raz 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. |
| 19267355 | Background | Eldor 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. |
| 11734230 | Background | Raz 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. |
| 17130576 | Background | Elias 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. |
| 16893923 | Background | Nussbaum 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. |
| 20034363 | Background | Fischer 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. |
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.
Placebo: 40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
| Treated |
|
| At Least One Post-baseline Visit (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients randomized into the study are included in presentation of baseline results
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DiaPep277 | 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. DiaPep277: 1.0 mg dose in 0.5 mL of solution |
| BG001 | Placebo | 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. Placebo: 40 mg mannitol in 0.5 mL of solution. Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Daily Insulin Dose | Mean | Standard Deviation | IU/kg/day |
| |||||||||||||||
| Fasting C-Peptide | Mean | Standard Deviation | nmol/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit | Posted | Mean | Standard Error | nmol*min/L | Baseline and 24 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit. | Posted | Number | 95% Confidence Interval | percentage of subjects | 24 and 25 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study | Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose 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 a daily insulin dose ≤ 0.5 IU/kg at study end. | Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit. | Posted | Number | 95% Confidence Interval | percentage of subjects | 24 and 25 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Hypoglycemic Events | Total number of days with at least one hypoglycemic event recorded | Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit | Posted | Number | days | Baseline to 25 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Days With at Least One Hypoglycemic Event | Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit | Posted | Mean | Standard Error | days | Baseline to 25 months |
|
|
AE data were collected from the time of subject enrollment through one month after the final product administrations (Total of 25 months after first study product administration)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DiaPep277 | 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. DiaPep277: 1.0 mg dose in 0.5 mL of solution | 15 | 236 | 171 | 236 | ||
| EG001 | Placebo | 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. Placebo: 40 mg mannitol in 0.5 mL of solution. Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months | 10 | 238 | 172 | 238 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tick-borne viral encephalitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tonsillitis Streptococcal | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Duodenal ulcer hemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Meniscus inury | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| multiple injuries | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sympathetic posterior cervical syndrome | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypoglycemic seizure | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Benign muscle neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastroenteriitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Psychiatric disorders | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Eye disorders | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
Investigator shall submit any paper or presentation to the Sponsor for review and comments at least 60 days prior to submitting the same to a third party. Upon receiving any request from the Sponsor to delete any Confidential Information or request to delay in publication up to 90 days to allow the filing of any Sponsor application, the Investigator shall take the request action. Investigator shall not be restricted after 18 months from completion of their site's performance in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeanne Novak | CBR International | 7207461190 | jnovak@cbrintl.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Hispanic |
|
| Black |
|
| Oriental |
|
| Asian |
|
| Other |
|
| Unknown |
|
|
|
|
|
|
|
|
|
|