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Insulin-Dependent clinical trials

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NCT ID: NCT02425410 Recruiting - Diabetes Mellitus Clinical Trials

Analysis of Viral Infections' Exposition Preceding the Type 1 Diabetes (T1D) Diagnostic in Children of the Isis-Diab Cohort. Search for Explanations of of the Disease's Early Onset

ISIS-VIRUS
Start date: March 2010
Phase: N/A
Study type: Observational

The purpose of this study is to investigate viral factors determining the early onset of T1D. Thanks to the quantification of viral exposures of T1D patients before the disease onset with questionnaires and environmental databases analyses, and through whole genome association studies of these patients, investigators could attempt to identify gene-virus interactions determining the age of T1D onset.

NCT ID: NCT02212522 Recruiting - Diabetes Mellitus Clinical Trials

Genetic and Environmental Risk Factors of Type 1 Autoimmune Diabetes and Its Early Complications

ISIS-DIAB
Start date: November 2004
Phase: N/A
Study type: Observational

The aim of this study is to complete the identification of genetic factors (G) and to undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G analysis (whole genome genotyping done once a patient using methods conually updated at Centre National de Genotype) and innovative E analysis to develop the following long term objectives : - Identify G and E factors influencing the process of remaining beta cells' destruction during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years diabetes duration); - Identify G factors (pharmacogenomics) of the individual response to insulin using the effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D patients with negative C-peptide and well managed diabetes); - Undertake a prospective research of G and E risk factors of "death in bed" syndrome in diabetic adolescents; - Undertake a prospective research of G and E risk factors of incipient glomerular microangiopathy (regule measurement of microalbuminuria).

NCT ID: NCT01973920 Completed - Diabetes Mellitus Clinical Trials

Efficacy Safety and Tolerability of Multiple Doses of Oshadi Icp (Oshadi Oral Insulin) in Patients With Type 1 Diabetes Mellitus - Phase II Clinical Study

Start date: December 2013
Phase: Phase 2
Study type: Interventional

Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current methods of insulin therapy for diabetic patients are multiple daily injection therapy and continuous subcutaneous insulin infusion with an external pump. This rout of administration may lead to hyperinsulinemia as insulin is administered in a non physiological way, targeting mainly extra hepatic tissues (muscle, fat). A method of providing insulin without the need for injections has been a goal in drug delivery. Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on biochemistry and quantum theory of biochemical reactions. The carrier enables the absorption of proteins from the gastrointestinal tract in their full structure. Oshadi has also developed the Oshadi Icp - insulin, proinsulin and C-peptide in Oshadi carrier, administrated orally. This study was design in order to evaluate the safety and feasibility of multiple administrations of Oshadi Icp for home use. The study will be a multiple-dose, open-label non-randomized study in patients with Type 1 diabetes, with periodic dose adjustments. The study will include 4 weeks of multiple-dose administration of Oshadi oral insulin (Oshadi Icp) at home and in study center for the determination of the efficacy, safety and pharmacodynamic effects of Oshadi Icp.