A Phase I/II Study of the Safety and Efficacy of Sernova's Cell PouchTM for Therapeutic Islet Transplantation...
Type I DiabetesThis is an open-label, single arm, non-randomized safety and efficacy study, where participants with Type-1 diabetes will receive the Sernova Cell Pouch™ implanted in the subcutaneous site, two to approximately twelve weeks prior to transplantation of islets into the Cell Pouch™. The primary objective of this study is to assess the safety of the Sernova Cell Pouch™ in adult participants with Type-1 diabetes receiving islet transplantation for the first time. Secondary objectives are the following: To determine the proportion of subjects implanted with the Cell Pouch™ and transplanted with islets into the Cell Pouch™ who achieve and maintain insulin independence after islet transplantation. To obtain preliminary data on the efficacy of the Cell Pouch™ to maintain adequate immunological protection against both allo- and autoimmunity of islet transplant recipients. To determine through retrospective analysis comparative metabolic function and engraftment efficiency using patients undergoing standard intraportal islet transplantation under the current alemtuzumab standard of care protocol.
OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277
Type 1 DiabetesThe study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study
Treatment With hOKT3gamma1(Ala-Ala) in T1DM
Diabetes MellitusType 1This is a phase II study to examine the clinical and immunological effects of humanized FcR non-binding anti-CD3 mAb in participants with Type 1 diabetes mellitus (T1DM), and to develop this therapy to prevent the immune destruction leading to β cell loss.
Tolerability, Safety, and Efficacy Study of INGAP Peptide to Treat Type 1 Diabetes Mellitus in Adults...
Type 1 Diabetes MellitusINGAP Peptide acetate is the active ingredient of INGAP Peptide Solution for Injection. It is being developed as an antidiabetic agent for the restoration of endogenous insulin secretion in patients with type 1 diabetes mellitus (T1DM) and in insulin-deficient patients with type 2 diabetes mellitus (T2DM). This clinical study is designed to generate additional data regarding the appropriate dose and dosing regimen and to evaluate safety and efficacy in patients with T1DM.
Inducing Remission in Type 1 Diabetes With Alefacept
New-onset Type 1 Diabetes MellitusThe purpose of this trial is to test whether a drug called alefacept will slow or halt destruction of the beta cells in the pancreas. If the destruction of the beta cells is stopped, the patients might be able to produce insulin on their own longer, which could stop or slow the progression of their type 1 diabetes. This is a multi-center prospective, placebo-controlled, double-blind and randomized trial to investigate the ability of alefacept to protect residual beta cells from ongoing autoimmune destruction in adolescents and young adults with newly diagnosed Type 1 Diabetes Mellitus (T1DM).
Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney...
Type 1 Diabetes MellitusThis research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary...
Type 1 Diabetes MellitusType 2 Diabetes Mellitus2 moreExamine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary safety
Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
Diabetes MellitusType 11 moreBased upon the preclinical evidence in models of diabetic nephropathy under conditions approximating both type I and II diabetes, treatment with alagebrium appears to have favorable and advantageous effects on the biochemical, structural, pathological and functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in preclinical models favor the evaluation of this drug in patients with type I diabetes.
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Type 1 DiabetesThe purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.
Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With...
Type 1 DiabetesHypoglycemiaThis research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level <70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.