Introduction
This protocol is prepared for a human research trial. Based on this document, the trial will be conducted in Canada and on Canadian residents or citizens, according to Good Clinical Practice part of International Conference on Harmonization guidelines (ICH/GCP E6), Health Canada Regulations (Part C, Division 5) applicable government regulations. Metformin is available in Canada as Apo-Metformin but Vildagliptin (Glavus) is not available in Canada and is needed to shipping from US under the Health Canada Regulations (Part C, Division 5).
1.1 Background
Diabetes mellitus is a common diseases in the world and Canada is diabetes mellitus. Diabetes Mellitus has been starting to grow all over the world. It is anticipated that the incidence of this disease will be increased dramatically in the next decade. The main reasons of this event are obesity, increasing the population mean age and reducing physical activities especially in industrialized countries. CCDSS has reported that in adult people who are over 20 years old, the prevalence of diabetes mellitus rate was 8.7% (95% CI: 8.72-8.74%), indicating one diabetic patient in 11 healthy Canadians A , B[3, 14].
The common sort of diabetes disease is Diabetes mellitus type 2 (T2DM) that covers the 90% diabetic cases. It is a metabolic disorder that is determined by hyperglycemia (high level of blood sugar) as a result of resistance to insulin in cell membrane and relative lack of insulin [2, 10]. Type 2 diabetes is a
Type II Diabetes, also known as diabetes mellitus, is also called non-insulin-dependent diabetes or aadult onset diabetes. It is a medical disorder that, due to a number of factors codependent with the modern world, is characterized by higher than normal blood glucose levels that play havoc with insulin deficiency and resistance. Insulin resistance means that cells do not respond appropriately when there is free insulin in the blood system. Essentially, they body is reacting to an improper balance of sugars and insulin. Because obesity is often present, research suggests that even thought the mechanisms controling glucose and insulin are unclear, the adopose tissue likely
Diabetes is a disease that cases blood glucose levels to rise higher than normal in the body. Type 2 diabetes is the most common form of diabetes when being compared to type 1diabetes. When blood sugars rises to levels higher than normal it is called hyperglycemia. Diabetes, type 2 can result in many different issues that affect the body. There are many complications that are linked with diabetes for example, higher risk
Type II diabetes is a chronic medical condition that affects the way the body uses glucose. With diabetes, the body can resist the effect of insulin or fails to produce enough insulin to preserve a glucose level within normal limits. Type II diabetes is becoming much more common than before and the occurrence is growing. Approximately 23.5 million people in the United States are living with type II diabetes (Fesselle, 2010).
Type 2 diabetes mellitus (T2D) is the most common form of diabetes (American Diabetes Association, 2012). T2D is so prevalent that it is estimated to be the fifth most common cause of death worldwide (Yates, Jarvis, Troughton, and JaneDavies, 2009, p. 1). T2D manifests when the body is unable to metabolize glucose properly, resulting in elevated blood sugar, debilitating fatigue, and other serious complications such as distal limb amputations, kidney failure, and blindness. The generally accepted causes of T2D include diet, sedentary lifestyle, and obesity.
Diabetes mellitus is a group of metabolic disorders characterized by inadequate insulin secretion by the pancreas or cellular destruction leading to an insulin deficiency. Depending on the cause of the insulin shortage, diabetes can be subcategorized into type I and type II. Type I diabetes (T1DM) is usually mediated by the destruction of b-cells in the pancreas resulting in decreased insulin production and secretion. Type II diabetes (T2DM) is the failure of these b-cells to secrete adequate amounts of insulin to compensate for insulin resistance and increased gluconeogenesis combined with an overall resistance to the insulin action (8., 1997). T2DM accounts
Diabetes is the leading cause of death in North America. In Canada, there are over 9 million people with diabetes and nearly 90% of them have type 2 diabetes. There are also many Canadians who have diabetes and do not know it (Canadian Diabetes Association). There are complications that can arise if diabetes is untreated or poorly managed; heart disease, kidney disease, eye disease and nerve damaged (St Michael's Hospital). Type 2 diabetes can be managed with physical activity and diet, as well as with education, maintaining healthy weight, medication, blood pressure control, glucose monitoring, and not smoking (St Michael's Hospital)(Canadian Diabetes Association). An individual’s risk of developing diabetes can be reduced with diets comprised of whole grains, fruits, vegetables, legumes and nuts. It is important to keep a diet low in refined
Type two diabetes is the most common disease today, and it has a great impact on the lives of many people in the United States. Type two diabetes results when the body is resistant to insulin or impaired secretion of insulin by the pancreatic beta cells. The pancreas produces too much insulin, but over time it is not able to make an adequate amount of insulin needed in order to move the glucose into the cells. However, there are many factors that lead to type two diabetes. They are known to be genetic, high body weight, previously identified impaired fasting glucose levels or impaired glucose tolerance, family history of diabetes, and history of gestational diabetes or delivery of a baby over 9 pounds. Type two diabetes effects about 90% to 95% of the cases of disease in the US (Hinkle & Cheever, 2013). It's
Diabetes is a metabolic disease where an individual’s blood glucose level is higher than normal standards. Diabetes is a long term condition that causes not only primary issues related to the disease but secondary problems as well. Diabetes also known and referred to by healthcare professionals as diabetes mellitus, which is a phrase used to describe a group of metabolic diseases in which a person’s body does not produce insulin at all, or a person’s body does not use insulin properly, which is called insulin resistance. Type I Diabetes also known as juvenile diabetes is when the body does not produce insulin, approximately 10% of all diabetes cases are type I. Type 2 diabetes is when the body does not use insulin properly and approximately 90% of all documented cases worldwide is of this type. (American Diabetes Association, 2014) All types of diabetes can be treated, type I has no known cure however there have been some cases where
Type II diabetes mellitus (DM), also referred to as non-insulin dependent diabetes, is a relative, rather than absolute, deficiency of insulin (ADA, 2004). It is global problem and has been identified as one of the “most challenging contemporary threats to public health” (Schauer et al., 2012). One is at risk for developing type II diabetes if they are overweight, over the age of 45, have a relative with type II diabetes, are sedentary, gave birth to a baby over 9 pounds, or had gestational diabetes (Center for Disease Control and Prevention [CDC], 2016).
Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is a common disease. It has both environmental and genetics determinants. Some of the causes of type two diabetes are gaining weight, eating foods or drinks with sugar, lack of exercise, stress, stress hormones. These are the environmental causes and people can withstand these by the way they live. People do not have control over genetics. Type 2 affects chromosomes 20, 17, 13, 12, and 7.
Diabetes is a condition, which causes the blood sugar of a person to become too high (Nhs, 2012). Type II diabetes is a long-term metabolic disorder that results from characterized high blood sugar, insulin resistance, or insulin deficiency (Elly, 2008). This type of diabetes differs from type I diabetes, which cause is quite unclear, but believed to result from genetic susceptibility and environmental factors. In type II diabetes, sugar accumulates in the bloodstream instead of being ferried by relevant body parts where it can be converted into energy
Type-II diabetes mellitus (also referred to as simply type-II diabetes or T2DM) is a chronic disease in which individuals are unable to produce adequate amounts of insulin from the pancreas, or who are unable to use any
Type 2 diabetes is a constant condition that influences the way the body forms glucose and is the most widely recognized kind of diabetes. It creates when the body gets to be impervious to insulin or when the pancreas quits delivering enough insulin. Insulin is a hormone that originates from the organ arranged behind and beneath the stomach (pancreas). Nobody knows precisely why this happens, in spite of the fact that hereditary qualities and ecological variables, for example, abundance weight
Diabetes mellitus is a chronic disease that involves the changes of blood glucose level in body systems. This disease usually inherited from generation to generation and sometimes it is due to lack of insulin produced by the pancreas. As the insulin produced is decreased, the blood glucose level will increase thus distressing the metabolism and damaging the body’s systems especially the blood vessels in kidneys, hearts, eyes and nervous systems (Nagappa et al., 2003).This disease have three different subtypes, type I (insulin dependent diabetes mellitus, IDDM), type II (non-insulin dependent diabetes mellitus, NIDDM) and gestational diabetes mellitus.
Type II Diabetes is the most common form of diabetes. It is simply defined by the American Diabetes Association as the bodies’ inability to utilize insulin properly. The pancreas produces an abundance of insulin to overcompensate for the excessive intake of sugars resulting in the inefficiency to produce enough insulin to keep blood