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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT00101751 Completed - Clinical trials for Diabetes Mellitus, Type 2

INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study

INITIATE plus
Start date: October 2004
Phase: Phase 4
Study type: Interventional

This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.

NCT ID: NCT00101712 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

Start date: October 2004
Phase: Phase 3
Study type: Interventional

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

NCT ID: NCT00101673 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Start date: March 2004
Phase: Phase 3
Study type: Interventional

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.

NCT ID: NCT00101530 Completed - Hypertension Clinical Trials

Improving Prevention of Heart Disease in Latinos

LUCHAR
Start date: September 2004
Phase: N/A
Study type: Observational

The purpose of the study is to improve cardiovascular disease (CVD) outcomes in racial and ethnic minorities. Specifically, it seeks to improve the primary prevention of CVD in Hispanics.

NCT ID: NCT00101478 Completed - Hypertension Clinical Trials

Improving Cardiovascular Treatment Approaches Among Minorities

Start date: September 2004
Phase:
Study type: Observational

The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and ethnic minorities. Specifically, the study will aim to improve provider and patient approaches to treatment of hypertension and diabetes, respectively.

NCT ID: NCT00100204 Completed - Diabetes Mellitus Clinical Trials

Salivary Proteins in Disease and Health

Start date: December 21, 2004
Phase: N/A
Study type: Observational

This study will examine saliva samples from healthy volunteers and patients with various diseases to learn more about how disease affects the mouth and salivary glands. It will use a method called salivary proteomics to identify multiple proteins in saliva and discover if there are protein patterns unique to specific diseases. The study will: - Characterize the salivary proteome in patients with Sjogren's syndrome, graft-versus-host disease, diabetes, sarcoidosis, cystinosis, dental caries, and immunodeficiencies and in patients who have had head and neck radiation - Evaluate the possible use of salivary proteomics for early diagnosis - Evaluate the potential use of salivary proteomics for prognosis and treatment Patients participating in NIH clinical studies who have Sjogren's syndrome, graft-versus-host disease, diabetes, sarcoidosis, cystinosis, dental caries, or an immunodeficiency, or patients undergoing head and neck radiation may be eligible for this study. Candidates are screened with a medical and dental history, head and neck examination, and photographs of any mouth sores or disease. Healthy volunteers also have blood drawn for routine laboratory testing. Participants have saliva collected from the floor of the mouth, the parotid salivary glands in the cheek, and the submandibular and sublingual salivary glands under the tongue. Patients with certain diseases also provide a urine sample. Saliva samples are collected as follows: - One time from healthy volunteers and patients with Sjogren's syndrome, diabetes, sarcoidosis, cystinosis and immunodeficiencies - Five times from patients undergoing stem cell transplant: at baseline before transplant and about 1, 2, 3 and 6 months after transplant. - Three times from patients undergoing head and neck radiation: at baseline before radiation and at 3 and 6 months after the conclusion of radiation.

NCT ID: NCT00100178 Completed - Clinical trials for Diabetes Mellitus, Type 1

New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial

TN02
Start date: May 2004
Phase: Phase 2
Study type: Interventional

The objective of this study is to identify immune intervention strategies that will preserve residual beta cell function at the onset of type 1 diabetes. Scientific evidence developed over the last 10 - 20 years suggests that type 1 diabetes is a chronic, slowly progressive autoimmune disease and that clinical symptoms do not develop until at least 80% - 90% of beta cell mass has been destroyed as a result of the autoimmune process. It is now recognized that preservation of remaining beta cells is clinically important as the ability to secrete, even small amounts of insulin, can make the disease easier to control and help minimize complications associated with having years of inadequate glycemic control. This clinical trial is the first in a series of studies to be launched by the TrialNet Study Group to test various interventions for preserving residual beta cell function in new onset type 1 diabetes. Specifically, this study is designed to determine the ability of Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab (DZB/Zenapax) to see if it is possible to stop the immune system from destroying beta cells in new onset type 1 diabetes patients (within 3 months of diagnosis.) Researchers have made great strides in understanding how the immune system works and in changing the activity of immune cells with medicines called immunotherapies. Some immunotherapies work by making the immune system less active. Scientists have discovered that key immune cells, called T cells, help to cause type 1 diabetes. These T cells are largely responsible for attacking the beta cells that produce insulin. Doctors have found medicines that slow or suppress the activity of T cells. It is hoped that these immunosuppressive medicines can help treat type 1 diabetes by stopping T cells before they destroy all of the beta cells. Medicines that make the immune system less active have been developed and studied for other diseases. Mycophenolate mofetil (MMF) and Daclizumab (DZB) are two of these medicines. Their effects on the immune system are well understood. Researchers believe these medicines may lessen the immune system's destruction of beta cells that leads to type 1 diabetes. In addition, researchers hope the effect of these medicines will last longer than other therapies. The goal of this study is to find out if two medicines are able to stop the ongoing destruction of beta cells which are still functioning at the time type 1 diabetes is diagnosed. The two immunosuppressive medications being tested are Mycophenolate mofetil (MMF/CellCept®) and Daclizumab (DZB/Zenapax®). They work by making the immune system less active. TrialNet researchers hope that these medications will help maintain insulin secretion from remaining beta cells and thus help to maintain better glycemic control. Even if the medications work, study participants will still need to take insulin injections but it may make it easier to control normal blood sugar levels which can help reduce long-term complications of diabetes such as blindness, kidney failure, nerve damage, heart attack and stroke. The aim is to arrest beta cell destruction in newly diabetic subjects because immune modulation may not work well alone once the autoimmune process has progressed to complete or near complete destruction of beta cells. The study's rationale is to demonstrate a meaningful preservation of islet function with minimal immune system side effects over the 4-year course of this study. The data from this clinical trial could serve as the basis for a larger trial if the results are sufficiently positive, or they could suggest other combined intervention trials that might achieve either better efficacy or potentially preserve C-peptide without the need for continued immunosuppression.

NCT ID: NCT00099957 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes

Start date: September 2003
Phase: Phase 2
Study type: Interventional

This study was not conducted in the United States. Many people with type 2 diabetes also have high cholesterol levels. The purpose of this study was to evaluate the effects of vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and cholesterol in people with type 2 diabetes.

NCT ID: NCT00099944 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

Start date: May 2004
Phase: Phase 3
Study type: Interventional

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.

NCT ID: NCT00099931 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Start date: May 2004
Phase: Phase 3
Study type: Interventional

Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.