Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset type 1 diabetes (T1D).


Clinical Trial Description

This Phase 1b/2a, multi-center study will be conducted in participants with clinical recent-onset type 1 diabetes (T1D). The primary objective of this study is to assess the safety and tolerability of different doses of AG019 alone as well as AG019 in combination with teplizumab. The secondary objectives of this study are: to obtain pharmacodynamic (PD) data of AG019 alone as well as AG019 in combination with teplizumab; and to determine the potential presence of AG019 in systemic circulation (safety - systemic exposure) and the presence of L. lactis bacteria in fecal excretion (local exposure): Pharmacokinetic (PK) profile. This study consists of 2 phases: Phase 1b: this open-label part of the study will investigate the safety and tolerability of 2 different doses of AG019 in 2 age groups (18-40 years of age and 12-17 years of age). Phase 2a: this randomized, double-blind part of the study will investigate the safety and tolerability of AG019, in combination with teplizumab, in 2 age groups (18-40 years of age and 12-17 years of age). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03751007
Study type Interventional
Source Precigen Actobio T1D, LLC
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 24, 2018
Completion date October 13, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05437913 - Protocol for Self-Compassion Intervention for Teens With Diabetes Type 1 and Their Caregivers N/A
Recruiting NCT03565770 - Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children N/A
Not yet recruiting NCT06437782 - Exploration of Health Literacy in Diabetes in Reunion Island and France
Not yet recruiting NCT05990933 - Role of Adrenaline in in the Inflammatory Response in Diabetes N/A
Recruiting NCT05669547 - Dual Hormone Closed Loop in Type 1 Diabetes N/A
Recruiting NCT06190756 - Impact of Gravity on Cardiac Hemodynamics N/A
Completed NCT05069727 - Simple Initiation of Advanced Hybrid Closed Loop System N/A
Recruiting NCT06460558 - T1D Closed-loop and Physical Activity
Recruiting NCT05866536 - Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years Phase 2
Not yet recruiting NCT06405373 - Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes N/A
Not yet recruiting NCT06405386 - Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes N/A
Completed NCT04635280 - Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Using a Closed-loop Automatic Insulin Delivery System N/A
Completed NCT05168657 - Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth N/A
Active, not recruiting NCT05574062 - Evaluation of the MiniMed 780 System in Paediatric Subjects N/A
Recruiting NCT05180591 - Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes Phase 2
Recruiting NCT05176795 - Host-microbiota-environment Interactions
Completed NCT05284071 - Actiste® Diabetes Management as a Service (ADMS) Clinical Investigation N/A
Completed NCT05933460 - Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1 N/A
Not yet recruiting NCT04772729 - Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes? Phase 4
Not yet recruiting NCT03170089 - Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus N/A