View clinical trials related to Type 2 Diabetes Mellitus.
Filter by:The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at Week 4. The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY [PYY3-36] and oxyntomodulin); and to assess the clinical and laboratory safety profile.
Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In order to prevent complications, patients need to monitor and control their blood sugar levels. In addition, they may need to have an ongoing communication with their doctor in order to modify treatment. In this study the investigators wish to compare the benefits of continuous glucose monitoring system (CGMS) to an internet-based glucose monitoring system (IBGMS). The investigators also want to determine whether the frequency of blood glucose testing affects blood glucose control and to see whether the benefits of CGMS and IBGMS are independent of testing frequency.
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea, over a period of 24 weeks of treatment. The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010) in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide over 24 weeks on percentage of patients reaching HbA1c less than (< ) 7 percent (%) or HbA1c less than or equal to (<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) and glucose excursion during standardized meal test, body weight; to evaluate safety, tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.
In 1995 we conducted a cross-sectional study to identify the effects of traditional and western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous region and at that time had experienced little change from their traditional lifestyle. Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized society and have a high prevalence of diabetes. We found that although T2DM and obesity were more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly lower prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population studied included a dramatically higher level of physical activity and a diet higher in fiber and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and Mexican Pimas share a similar gene pool we concluded that even in populations genetically prone to T2DM and obesity, their development is determined largely by environmental circumstances. Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed. The electrical supply to the region has increased, cars have become more prevalent and grocery stores have appeared. The impact of these changes on T2DM and obesity has not been examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same measures used previously, including height, weight, waist circumference, body composition by bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the same methods as the 1995 study to the previous results and 3) document the frequencies of T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and non-Pima Mexicans.
It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.
Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by using soluble dietary fibres) may reduce the glycemic or insulinemic response. This may in turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic profile in the longer term.
The aim of this study was to evaluate the correlation between 1,5-Anhydroglucitol in patients with HbA1C <7%, and glycemic excursions as assessed by the continuous glucose monitoring system compared to fructosamine.
Primary Objective: - To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes. Secondary Objectives: Pharmacodynamic objectives: - To assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart. Pharmacokinetic objective: - To assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups Safety objective: - To assess the safety of insulin glulisine in comparison to insulin aspart
Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative insulin insufficiency and insulin resistance that are associated with a cluster of abnormalities that increase the risk for cardiovascular disease including dyslipidemia, inflammation, hemodynamic changes and endothelial dysfunction. The dyslipidemia associated with T2D is characterized by elevated triglycerides and decreased high-density lipoprotein-cholesterol (HDL). The ability of the insulin sensitizing agent pioglitazone (ACTOS®) , to improve hyperglycemia in subjects with T2D is now well established. Pioglitazone functions as a PPAR-γ (peroxisome proliferator-activated receptor gamma) agonists and this class of drugs have demonstrated several other potential benefits, beyond glucose homeostasis. Specifically pioglitazone can improve diabetic dyslipidemia by increasing HDL cholesterol and lowing triglycerides. A potential beneficial effect on reverse cholesterol transport may be mediated by the increased HDL levels. This proposal aims to examine the effect of PPAR-γ activation by PIO on various aspects of reverse cholesterol transport by testing the hypothesis that PIO treatment affects key steps in the reverse cholesterol transport pathway either directly, through induction of protein expression, or indirectly, by altering HDL structure and composition leading to increase cholesterol flux through this pathway.
The purpose of this study is to determine the safety and pharmacokinetics of double-blind S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus