Active clinical trials for "Diabetes Mellitus, Type 1"

This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.

The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in patients with Type1 Diabetes Mellitus treated with insulin.

The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).

The proposed studies describe a randomized trial to evaluate the safety of a new diabetes-suppressive cell vaccine, consisting of autologous monocyte-derived dendritic cells treated ex vivo with antisense phosphorothioate-modified oligonucleotides targeting the primary transcripts of the CD40, CD80 and CD86 co-stimulatory molecules (immunoregulatory DC; iDC). The hypothesis to be tested in this study is that iDC are safe and without toxicity in established type 1 diabetic patients. Fifteen (15) individuals exhibiting fully-established, insulin-dependent type 1 diabetics, without any diabetes-related complications, infectious disease, or other medical anomaly, will be enrolled to establish safety of the approach. 7/15 volunteers will be administered autologous control dendritic cells and 8/15 will be administered iDC. The study is anticipated to be complete by twelve (12) months. Currently, other than a humanized anti-CD3 antibody with considerable side effects, there is no other means to reverse new-onset type 1 diabetes. These studies will be the first ever to employ autologous dendritic cell transfer to suppress an autoimmune disease and to perhaps reverse it early on in the clinical process.

Type I diabetes (T1DM) is associated with an increased risk of vascular complications. While the precise mechanism(s) by which diabetes accelerates atherosclerosis has not been elucidated, several lines of evidence point to the role of increased inflammation in the pathogenesis of these vasculopathies. The monocyte-macrophage is a pivotal cell in atherogenesis and is readily accessible for study. However, there is scanty data on monocyte function and inflammation in T1DM. Simvastatin, a HMG-CoA reductase inhibitor, has recently been shown to reduce cardiovascular events in diabetic patients (T1DM and T2DM in the Heart Protection Study). Recent studies demonstrate that simvastatin decreased C-reactive protein and decreased pro-atherogenic activity of monocytes in non-diabetic subjects. However, there is a paucity of data on the effect of simvastatin on inflammation and monocyte function in Type 1 diabetes. Thus, the purpose of this study is Aim 1) to assess biomarkers of inflammation in T1DM compared to matched controls (n=50/group). Aim 2) Also, we will assess the effect of simvastatin (20mg/day) therapy on inflammation and monocyte function in T1DM in a randomized, placebo-controlled, double blind trial.

The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions. The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.

The purpose of this study is to determine whether there is a difference in blood sugar control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin injections incorporating a new long acting insulin analogue (detemir) compared to children using their current three times a day insulin injections (with intermediate and rapid acting insulin).

Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need insulin injections, blood sugar monitoring several times each day, and adhere to a strict diet. Adequate control of blood glucose is essential to prevent long term kidney and eye complications that result in kidney failure and blindness. Adolescence is a time when diabetes is difficult to control, due in part to high growth hormone levels causing insulin resistance ( a state where the body does not respond as strongly to insulin). This study will test whether treatment with rosiglitazone (an oral medication used frequently in type 2 diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1 diabetes during puberty.

Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels. T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune system attacks the body itself. In addition to regulating blood sugar, insulin may have the ability to protect cells in the pancreas from attack by the immune system. This study will evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction. Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or slowing of the ongoing autoimmunity, and this will result in an appreciable difference in functioning B cell mass compared to the placebo treated group by the end of the study.

This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.