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NCT ID: NCT01302145 Completed - Clinical trials for Type 2 Diabetes Mellitus

Drug to Drug Interaction Study With ASP1941 and Metformin

Start date: February 25, 2009
Phase: Phase 1
Study type: Interventional

A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.

NCT ID: NCT01302132 Completed - Healthy Subjects Clinical Trials

Mass Balance Study of ASP1941

Start date: May 2008
Phase: Phase 1
Study type: Interventional

This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.

NCT ID: NCT01300013 Completed - Heart Failure Clinical Trials

Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.

NCT ID: NCT01299727 Terminated - Sanfilippo Syndrome Clinical Trials

Extension of Study HGT-SAN-055 Evaluating Administration of rhHNS in Patients With Sanfilippo Syndrome Type A (MPS IIIA)

Start date: March 1, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease (LSD) caused by loss in activity of 1 of 9 enzymes necessary for degradation of the glycosaminoglycan (GAG) heparan sulfate (HS) in lysosomes. MPS IIIA results from deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence of this enzyme, intermediates of the HS degradation process accumulate in the lysosomes of neurons and glial cells, with lesser accumulation outside the brain. MPS IIIA symptoms arise on average at 7 months of age, with the average age of diagnosis at 4.5 years for the majority of patients. Patients present a wide spectrum and severity of clinical symptoms. The central nervous system (CNS) is the most severely affected organ system in patients with MPS IIIA, evidenced by deficits in language development, motor skills, and intellectual development. In addition, there are abnormal behaviors including but not limited to aggression and excess motor activity/hyperactivity that contribute to disturbances in sleep.Overall, individuals with MPS IIIA have a marked developmental delay and significantly reduced lifespan to 15 years of age on average. The purpose of this study is to collect long term safety and tolerability data in patients with MPS IIIA who previously received rhHNS in study HGT-SAN-055 (NCT01155778).

NCT ID: NCT01299506 Completed - Soft Tissue Sarcoma Clinical Trials

Study in Patients With Advanced Soft Tissue Sarcoma (STS) After Failure of Anthracyclines and/or Ifosfamide

Start date: December 2010
Phase: N/A
Study type: Observational

This is an observational, non-randomized, open label, multicenter, phase IV study, which aims to reflect a real-life practice routinely used for the management of advanced soft tissue sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive these drugs in the Netherlands. This study pretends to reflect the use and schedule of chemotherapy regimen with trabectedin and/or other conventional care regimens such as other palliative chemotherapy/biological therapies or best supportive care (BSC) in the management of advanced soft tissue sarcoma patients in the clinic based at the discretion of the Investigator. There are no pre-defined limits of administered cycles of trabectedin treatments or chemo- and/or biological therapy; thus, those treatments may continue as long as deemed necessary by the Investigator

NCT ID: NCT01299311 Completed - Overweight Clinical Trials

NEAT and Insulin Sensitivity

Start date: December 2010
Phase: N/A
Study type: Interventional

The effect of Non-Exercise Activity Thermogenesis (NEAT) or inactivity on insulin sensitivity and lipid metabolism is unclear. Research recently published shows that activities associated with everyday activities, summarized as NEAT, such as walking and standing, have a much greater role in energy expenditure than exercise. Therefore, the objective of the present study is to evaluate the effect of 4 days of inactivity (mainly sitting), 4 days of everyday activities (sitting, walking and standing), and 4 days of inactivity and exercise (sitting and biking) on glucose metabolism and insulin sensitivity using an oral glucose tolerance test, and on lipid metabolism in sedentary, overweight people. The investigators hypothesize that: 1. 4 days of everyday activities (NEAT) will cause an increased glucose tolerance and increased insulin sensitivity compared to 4 days of inactivity in sedentary, overweight people. 2. 4 days of exercise will improve glucose tolerance and insulin sensitivity more than 4 days of NEAT with equal energy expenditure, in sedentary, overweight people. 3. Fasting triglyceride will have the same course as glucose, mentioned in 1. and 2.

NCT ID: NCT01298492 Completed - Crohn's Disease Clinical Trials

A Study To Monitor Long-Term Treatment With PF-00547659

OPERA II
Start date: July 1, 2011
Phase: Phase 2
Study type: Interventional

This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

NCT ID: NCT01298375 Recruiting - Healthy Clinical Trials

Metabolic Phenotyping in Humans

MetPhe
Start date: March 2011
Phase:
Study type: Observational

Type 2 diabetes (T2D) is a global burden disease affecting almost 200 million people and is expected to nearly double by 2030 (1). It is imperative that this disease is kept under control, and that we begin to reverse the direction of its incidence. We propose to start by identifying the physiological and molecular aspects of the problem in all spectrums of the disease (ie from insulin sensitive athletes to sedentary lean and obese individuals and further to overt type 2 diabetics), and focus our efforts on examining the differences and identifying the stages of progression for possible targets of future intervention. The proposed study "Metabolic Phenotyping" is novel in its target populations and innovative in its use of state-of-the-art techniques. We hypothesize that the in vivo differences in metabolic flexibility and mitochondrial function between endurance athletes and type 2 diabetics and their lean and obese controls are retained in vitro and will offer a new model in which to study the underlying mechanisms of the progression of T2D.

NCT ID: NCT01297738 Completed - Obesity Clinical Trials

Diet, Insulin Sensitivity And the Brain

DISAB
Start date: February 2011
Phase: N/A
Study type: Interventional

Obesity and insulin resistance may be in part explained by an altered reward system with changes in the serotonin/dopamine system. These changes might be caused by changes in dietary habits, especially by an increased intake of liquid sugar and an increase in meal frequency. The investigators hypothesize that increasing meal frequency compared to increasing meal size and when consuming a hypercaloric high-sugar diet (HS) compared to a hypercaloric high-fat-high-sugar diet (HFHS) will result in a reduction in cerebral serotonin and dopamine transporters and in a more prominent increase in insulin resistance. In addition, the investigators hypothesize that the changes in insulin sensitivity will be independent of changes in abdominal (visceral) and liver fat and that changes in insulin sensitivity due to the dietary manipulation will co-occur with changes in insulin signaling pathways in peripheral fat and muscle tissue.

NCT ID: NCT01297491 Completed - Clinical trials for Non-small Cell Lung Cancer

Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

BASALT-1
Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.