Active clinical trials for "Diabetes Mellitus, Type 2"

Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac injury. Previous research has shown that type 2 diabetic patients may experience large increments in cTnT levels over the subsequent hours following a single bout of moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent evidence indicates that ingestion of dietary nitrates dramatically increases the bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion injury. The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT levels following exercise in type 2 diabetic patients.

The purpose of this study is to determine whether a non-hematopoietic erythropoietin analogue, ARA 290, exerts beneficial effects on blood glucose levels and insulin secretion in persons with prediabetes (impaired glucose tolerance, IGT, or impaired fasting glucose, IFG), or drug-naive type 2 diabetes. The study will also evaluate effects of ARA 290 on insulin sensitivity and serum levels of inflammatory agents, e.g. cytokines. In addition, safety will be monitored by following parameters related to hematology, kidney and liver function and lipid levels.

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control. Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c > 10%)

This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.

Type 2 diabetes mellitus is a chronic metabolic disorder which is caused by both insulin secretion deficiency and insulin action defect. In this type of subjects, fasting hyperglycemia is the result of the elevated rate of basal hepatic glucose production, and it is coexisting with hyperinsulinemia.After a meal, the impaired control of hepatic glucose production by insulin and decreased insulin-mediated glucose uptake by muscle contributed nearly equally to postprandial hyperglycemia(Scheen, 1997). Type 2 diabetic subjects experience significant morbidity and mortality from microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular (cardiovascular disease, stroke, and peripheral vascular disease) complications. The appropriate treatment and good glycemic control of diabetes is therefore important and necessary (Vaag, 2006). Evidences suggest that combination therapy using oral antidiabetic agents with different mechanisms of action may be more effective in achieving and maintaining target blood glucose level (Turner et al., 2005).There are five classes of oral antihyperglycemic agents (sulfonylureas, biguanides, α- ucosidase inhibitors, thiazolidinediones and meglitinides) currently available to improve glycemic control in subjects with type 2 diabetes, each of which works through a different mechanism of action. Metformin, a biguanide which has insulin-sensitizing properties, can be used alone or in combination with other classes of agents. Metformin is the currently the first-choice treatment in subjects with diagnosed type 2 diabetic subjects and obesity, characterized by insulin-resistance. Metformin also provides reduction of body weight and ameliorates lipid abnormalities and is thought to be related to a reduction in hepatic gluconeogenesis (Hundal & Inzucchi, 2003).Acarbose, the α-glucosidase inhibitor, is approved for the treatment of type 2 diabetes, and first approved for prediabetes treatment (Chiasson et al., 1994; Breuer, 2003; Chiasson et al., 2002). The drug was launched worldwide as a type 2 diabetes monotherapy and combination therapy in 1990 which has proven efficacious as first-line therapy (Coniff et al., 1995) and in combination with sulfonylureas or insulin (Kelley et al., 1998). Acarbose and metformin are both associated with beneficial effects on hyperglycemia, hyperinsulinemia, body weight, and, in some studies,triglyceride levels (Krentz et al., 1994). Because these factors are part of a cluster of risk factors for cardiovascular disease, combining the two drugs may be useful. In long-term clinical studies, acarbose has shown a favorable safety profile (Hasche et al., 1999).In combination with metformin, acarbose has been shown to improve long-term glycemic control (Rosenstock et al., 1998; Halimi et al., 2000). This study was conducted as a further vestigation into the efficacy and safety of concurrent use of acarbose and metformin in type 2 diabetes mellitus subjects.Lotus Pharmaceutical Co., Ltd. intends to initiate Phase III program to investigate assess the efficacy and safety of metformin in combination with acarbose for type 2 diabetes mellitus subjects considered inadequately blood glucose control. Since combination tablet of acarbose and metformin has not yet been approved by the Taiwan DOH, this study is conducted to evaluate the efficacy and safety of combination tablet of acarbose and metformin in the treatment of type 2 diabetes mellitus subjects in Taiwan. Acarbose is chosen as an active-comparator.

Individuals with a family history of type 2 diabetes mellitus (T2DM) are known to be at greater risk for the disease, and studies have shown that how the body responds to insulin, how the muscle creates energy, and the amount of fat stored inside skeletal muscle are often different in these individuals at a young age compared to people without a family history of the disease. The tendency to develop T2DM is influenced strongly by genetics; however, exposure to the surrounding environment may also play a role. The exposure to a diabetic environment while in the womb represents an altered nutritional exposure (high levels of circulating sugar, or glucose) that may affect how tissues important in regulating energy metabolism, such as the pancreas, liver, and skeletal muscle, develop. the purpose of this study is to measure sensitivity to insulin, energy expenditure, fat content of the abdomen and skeletal muscle function in young adult sibling pairs who were raised together but who are discordant for intrauterine exposure to diabetes (i.e., the mother did ot have diabetes during pregnancy with the older sibling, but did have diabetes during pregnancy with the younger sibling).

The purpose of this study is to investigate and evaluate the effects of different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

The planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are missing, it is not possible to calculate sample size and statistical power. Therefore the goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations and estimations on the probability of success of HERMES.

It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this study, we are determined to use the golden standard of insulin sensitivity evaluation in vivo-hyperinsulinemia euglycemic glucose clamp-to estimate insulin resistance improvement in patients before and after intensive insulin therapy, investigate first phase insulin secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin secretion resulting from normalization of plasma glucose levels in both lean and obese patients by insulin pump therapy.

This protocol is being conducted to determine the mechanisms responsible for insulin resistance, obesity and type 2 diabetes.