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E1 and G1

A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1

Ensayo de OPKO HEALTH, INC. en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

Fase 1

Estado

Completado

Participantes

20

previstos

Centros

5

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en jun 2005.

Qué mide

To evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetes (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of the study is to determine whether E1 and G1 are safe and effective in the treatment of type 1 diabetes. Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta cells. These cells produce insulin, which regulates blood glucose. The mainstay of current treatment for type 1 diabetes is dietary control and daily parenteral administration of insulin. Recent diabetes research has increasingly focused on pancreatic islet cell replacement, either by islet cell transplantation or by endogenous regeneration of islet cells. During fetal development, islet precursor cells proliferate and differentiate into mature beta cells capable of producing insulin. This process is known as islet cell neogenesis. Islet cell neogenesis normally ceases around birth, however, the adult pancreas still retains significant potential for islet regeneration, as shown by tissue repair following pancreatic injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis and increase pancreatic insulin production in diabetic animal models. It is therefore postulated that treatment with E1 and G1 may produce islet cell regeneration in type 1 diabetic patients.

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Ficha completa en ClinicalTrials.gov (NCT00239148), actualizada en oct 2019.