Diabetes Mellitus, Type 1 Clinical Trial
— STRIDEOfficial title:
A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
| Status | Recruiting |
| Enrollment | 96 |
| Est. completion date | January 2025 |
| Est. primary completion date | January 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: - Able to understand the study requirements and provide written informed consent before any study assessment is performed - Male or female patients = 18 to 45 years of age - A diagnosis of type 1 diabetes Exclusion Criteria: - Women who are pregnant, lactating, or planning on pregnancy during the study - History of cancer - History of heart disease - Recent infection |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ Brussel | Brussel | |
| Belgium | UZ Leuven | Leuven | |
| France | CHU Grenoble Alps | Grenoble | |
| France | Université Paris Cité | Paris | |
| Germany | AUF DER BULT Kinder- und Jugendkrankenhaus | Hanover | |
| Germany | Institut fu¨r Diabetesforschung Mu¨nster GmbH | Münster | |
| Germany | Profil Institute for Metabolic Research | Neuss | |
| Italy | Azienda Ospedaliero-Universitaria Renato Dulbecco | Catanzaro | |
| Italy | Luigi Sacco Hospital | Milan | |
| Italy | San Raffaele Hospital | Milan | |
| Italy | University of Pisa | Pisa | |
| Italy | University of Siena | Siena | |
| Poland | EMC Silesia Katowice | Katowice | |
| Poland | Medical University of Lodz | Lódz | |
| Poland | EMC Piaseczno | Piaseczno | |
| Poland | Central Clinical Hospital of the Ministry of Interior and Administration | Warsaw | |
| Poland | Military Clinical Hospital | Wroclaw | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitari de Bellvitge | Barcelona | |
| Spain | Hospital Universitari de Girona Dr. Josep Trueta | Girona | |
| Spain | Hospital General de Segovia | Segovia | |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Spain | Hospital Clinico Universitario de Valladolid | Valladolid | |
| Sweden | Karolinska University Hosptial | Stockholm | |
| United Kingdom | University of Birmingham | Birmingham | |
| United Kingdom | Bradford Teaching Hospitals NHS Foundation Trust | Bradford | |
| United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | |
| United Kingdom | Dorset County Hospital NHS Foundation Trust | Dorchester | Dorset |
| United Kingdom | Ninewells Hospital | Dundee | |
| United Kingdom | Liverpool University Hospitals NHS Foundation Trust | Liverpool | Merseyside |
| United Kingdom | Guy's and St. Thomas' NHS Foundation Trust | London | |
| United Kingdom | St George's University Hospitals NHS Foundation Trust | London | |
| United Kingdom | East Kent Hospitals University NHS Foundation Trust | Margate | |
| United Kingdom | Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | |
| United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford | |
| United Kingdom | Northern Care Alliance NHS Foundation Trust | Salford | |
| United Kingdom | Swansea Bay University Health Board | Swansea |
| Lead Sponsor | Collaborator |
|---|---|
| ITB-Med LLC |
Belgium, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in beta-cell function as compared to placebo at week 52. | Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator). | 52 weeks | |
| Secondary | Assess the incidence and severity of adverse | Number of adverse events compared to placebo at week 52. | 52 weeks |
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