Active clinical trials for "Diabetes Mellitus, Type 2"

Hyperlipidemia and atherosclerosis lead to cardiovascular diseases and are an indirect cause of increased death rate in the general population. This association is still more evident in specific subpopulations, like patients with advanced chronic kidney disease (CKD), especially hemodialysis (HD) patients, due to a higher prevalence of lipid disturbances and atherosclerosis compared to the general population. Cardiovascular events in CKD patients are frequently associated with traditional risk factors, including diabetes, male sex, hypertension, dyslipidemia and advanced age. However, these factors failed to fully account for the increased risk of cardiovascular events in CKD. The efforts are made to identify new risk factors that contribute to the development of atherosclerosis and participate in causes of cardiovascular death. In 2003, there were identified peptides designated salusin-alpha and salusin-beta. Development of atherosclerosis may be suppressed by salusin-alpha. Salusin-alpha may have a lipid lowering effect, similar to that of statins. The purpose of this study is to investigate whether 1) salusin-alpha is associated with lipid metabolism of HD patients (without or with metabolic syndrome or type 2 diabetes mellitus), similarly or not like in healthy or obese subjects; 2) treatment with atorvastatin and its effects are associated with changes in plasma salusin-alpha concentration, if so - whether it is dependent on the direct influence of atorvastatin on salusin-alpha or associated with a decrease in serum lipid level; 3) salusin-alpha may predict mortality in HD patients.

The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.

This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.

Some gut hormones, called incretins, stimulate insulin production in order to control sugar levels but also activate brain centres and signal to stop eating. Current administration of incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the skin) injection and has been routinely available for diabetic patients for more than 4 years. It is an effective treatment for the lowering of blood glucose with an average weight loss of about 3-4kg.Recent evidence, from animal studies and limited human studies, suggests that incretins based treatments may also have beneficial effects on blood vessel function. However, it is not known whether this effect is by direct action on the blood vessel independent of an improvement of latent inflammation which is typically associated with weight loss or an anti-inflammatory effect of the incretin treatment itself. The aim of this study is to determine whether the incretin-based diabetes treatment with the GLP-1 (Glucagon-like peptide 1) analogue Liraglutide (also known as Victoza), which mimics the actions of incretins, improves blood vessel function in individuals with type 2 diabetes. It will determine whether the improvement in blood vessel function is independent of the effect of weight loss and changes in inflammation. This by the study of vascular function before and after 4 months of Victoza treatment in subjects with Type 2 diabetes in comparison with 1) participants randomized to hypo-caloric diet to achieve a similar weight loss than with Victoza and 2) participants randomized to treatment with once daily aspirin. Comprehensive assessment of blood vessel function, body fat distribution and metabolic profile at baseline and at the end of the treatment phase will be combined with assessments of inflammation markers in blood and in fat tissue biopsies.

Oral hypoglycemic agents, along with dietary modification and exercise encompass the mainstay of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two major groups of hypoglycemic medications that while function via different pathways, mare both effective in short- and long-term glucose control. These medications diminish or delay long term micro- and macrovascular complications associated with T2DM although at different rates. Excessive insulin resistance accounts for a sustained increase in cardiovascular incidents in T2DM subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in atherosclerosis formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to modify successive CAD risk via direct and indirect amelioration of insulin resistance/fetuin-A/OPG. The present study is therefore designed to investigate the effects of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and OPG in a group of Iranian adults with newly diagnosed T2DM.

Type II diabetes is associated with a host of adverse and costly complications, including heart attacks, strokes, blindness, kidney failure, and severe neuropathy that may result in amputations. For those with diabetes, glycemic control is essential to minimize complications but many fail at being sufficiently adherent to their treatment. The investigators propose to test two incentive-based intervention strategies aimed at improving diabetes outcomes amongst patients with uncontrolled glycemic levels. The incentives are tied either to processes aimed at improving blood sugar levels (glucose testing, physical activity and medication adherence) or directly to the intermediary outcome (blood glucose in the acceptable range). While process incentives are likely to provide more motivation for treatment adherence, as these goals may be comparably easier to meet, these incentives only reward intermediary outcomes and it might be more effective to reward successfully achieving a health outcome directly.

This study consists of two parts. Part 1 evaluates the effect of renal impairment on the PK and PD of a single dose of ASP8232. In addition, the safety and tolerability will be assessed. Part 2 evaluates the PK, PD, and safety and tolerability of multiple doses of ASP8232 compared with placebo in Type 2 Diabetes Mellitus (T2DM) subjects with Chronic Kidney Disease (CKD).

This study will be an open-label study to evaluate the effect of albiglutide on the pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon). The primary objective of this study is to demonstrate the lack of effect of albiglutide doses on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.

To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.

Many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control. There is an urgent need to enhance treatment for those who do not reach goals within the usual clinical care system. We propose to develop a multi-component intervention grounded in the Chronic Care Model, and sustainable in resource-challenged settings. Through collaboration with home health nursing and with the use of home telemetry for feedback and intensification of therapy, we will augment usual clinical services to improve health outcomes for diabetes patients who have not been able to reach therapeutic goals. There are three specific aims. First, we will establish a feasible, practical and sustainable collaborative model between the primary care sites of our practice-based research network (NYC RING), clinical researchers at the Diabetes Research and Training Center, and The Montefiore Home Health Organization, integrating the unique expertise of each of the partners and defining the roles and responsibilities of each. Second, we will develop and refine the components of the intervention, to include training primary care providers and home health nurses to integrate the technical, psychosocial and communication processes for implementation of the intervention. Third, we will assess the feasibility of the collaborative intervention by implementing the intervention for 25 primary care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25 patients receiving usual care. Our proposal includes plans to develop feasible procedures for data collection, with qualitative and quantitative methods of assessing process and outcome measures. We will use these preliminary data to revise the intervention and prepare an R18 application to further develop and test the intervention in multiple inner-city primary care sites serving low-income diabetes patients. This proposal is for secondary prevention of diabetes complications, targeting a population known for health disparities and a high burden from this chronic disease.