drugset / Trial / NCT02580877
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Phase 2
Completed
92 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 1 Diabetes TrialNet · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).
Timeline
- Start
- 2016-01
- Primary completion
- 2018-03
- Completion
- 2018-03
Publications
- Background Skyler JS, Krischer JP, Wolfsdorf J, Cowie C, Palmer JP, Greenbaum C, Cuthbertson D, Rafkin-Mervis LE, Chase HP, Leschek E. Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial--Type 1. Diabetes Care. 2005 May;28(5):1068-76. doi: 10.2337/diacare.28.5.1068.
- Background Bonifacio E, Ziegler AG, Klingensmith G, Schober E, Bingley PJ, Rottenkolber M, Theil A, Eugster A, Puff R, Peplow C, Buettner F, Lange K, Hasford J, Achenbach P; Pre-POINT Study Group. Effects of high-dose oral insulin on immune responses in children at high risk for type 1 diabetes: the Pre-POINT randomized clinical trial. JAMA. 2015 Apr 21;313(15):1541-9. doi: 10.1001/jama.2015.2928.
- Jacobsen LM, Schatz DA. Insulin immunotherapy for pretype 1 diabetes. Curr Opin Endocrinol Diabetes Obes. 2021 Aug 1;28(4):390-396. doi: 10.1097/MED.0000000000000648.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | 67.5 mg | Oral |
| Subject | Insulin | Protein / enzyme biologic | 500 mg | Oral |