Canagliflozin vs Placebo in Type 2 Diabetes for CV and Renal Events

Achal Patel, Mercer University College of Pharmacy

Type 2 diabetes (T2D) is the more common form of diabetes mellitus compared to type 1 diabetes (T1D) and accounts for ~90% of all diabetes patients. [1] Complications of diabetes include cardiovascular, macrovascular, microvascular, peripheral nerve, and renal diseases. Evidence shows that use of SGLT2 inhibitors may help in reducing the risk of cardiovascular complications, albuminuria, and renal diseases. [2]

Canagliflozin (Invokana®), is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that lowers the renal threshold for glucose and increases urinary glucose excretion by interfering with the reabsorption of renally-filtered glucose across the tubular lumen of the proximal renal tubules. [3] Sodium-glucose cotransporter 2 inhibitors are the most recent type of diabetic agents approved for T2D management in the U.S. Previously, the Food and Drug Administration published a guidance for industry that new diabetic agents should be assessed for their cardiovascular safety. [2] The article below summarizes two canagliflozin trials that assessed its effect on CV risks (CANVAS) and albuminuria (CANVAS-R).

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Degludec Versus Glargine in Type 2 Diabetes for CV Risk

Tibin K. Titus, Mercer University College of Pharmacy

Type 2 diabetes affects millions of people worldwide. [1] Among the complications that arise from diabetes are cardiovascular (CV) complications such as stroke, coronary heart disease, and vascular disease. [1] Additionally, studies have shown that type 2 diabetics who require insulin have increased rates of cardiovascular events. [2,3]

Degludec is a new and ultra long acting basal insulin that came into the market in 2016. It is approved for glycemic control in type 2 diabetes. The Food and Drug Administration (FDA) requires all new diabetes drugs to have a CV risk study. [6] To fill the gap in knowledge for the CV safety of degludec, the following study was conducted. [7]

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Sotagliflozin Added to Insulin in Type 1 Diabetics

Shanterra Grable, Mercer University College of Pharmacy

Type 1 diabetes, previously considered juvenile diabetes, affects approximately 29 million adults worldwide. It develops when the pancreas stops producing insulin, eliminating the body’s ability to maintain glucose control. The autoimmune disease can have a rapid onset and must be managed with insulin administered via injection or by pump.  It is  approximated that less than one-third of people living with type 1 diabetes achieve the target A1c of less than 7%. [1]

Sotagliflozin is the newest agent in a class of antidiabetic agents known as sodium –glucose cotransporter 1 and 2 (SGLT2) inhibitors. Prior phase two studies on sotagliflozin have shown improved glycemic control, reduced body weight, and reduced glycemia in both type 1 and type 2 diabetics. None of the current medications on the market are approved for use in conjunction with insulin to lower glucose in type 1 diabetic patients. The inTandem3 phase three trial evaluated the effects of sotagliflozin when used in combination with insulin on glycemic control, instances of severe hypoglycemia, and diabetic ketoacidosis in adults with type 1 diabetes. [2]

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Effect of Oral Semaglutide Compared with Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients with Type 2 Diabetes

Julia Lvovich, Mercer University College of Pharmacy

Worldwide, type II diabetes affects 9% of male population and 7.9% of female population. [1] It has been shown that genetics, lifestyle, and environment factors can predispose adults and children to develop insulin resistance that leads to increased glucose levels in the blood. Overtime, prolonged exposure to high blood glucose levels causes damage to blood vessels and increases risk for coronary artery disease, kidney disease, and obstructive sleep apnea. [2] Treatment of type II diabetes can be targeted with lifestyle modifications (e.g. weight and diet management, exercise) and pharmacotherapy. When considering pharmacotherapy agents, the choices depend on the desired lower blood glucose hemoglobin A1C (HbA1C) reduction, weight gain/loss properties, and other comorbidities. [1]

Glucagon-like peptide -1 (GLP-1) receptor agonists are incretin mimetics and lower HbA1C level by 0.5-1.5%. [3] These drugs also possess weight loss property, which provides an added benefit in type II diabetic patients. However, they are only available in injection formulations due to degradation of the peptides by stomach acid. [4] To overcome the pharmacological limitation, an oral GLP-1 receptor agonist was co-formulated with an absorption enhancer, which increases the local pH to prevent the degradation in the stomach. The efficacy and safety of the new drug, semaglutide, has been evaluated in a phase II trial, which is summarized below.

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Predictors of Long-term Discontinuance with Noninsulin Antihyperglycemic Agents

Qaashif Panjwani, Mercer University College of Pharmacy

The cost-burden of diabetes to the U.S. healthcare system as of 2012 is $245 billion. The general breakdown of direct medical expenditures includes the following: hospital inpatient care (43%), prescription medications to treat complications (18%), antidiabetic agents and diabetes supplies (12%), physician office visits (9%), and nursing-residential facility stays (8%). 1

There are many microvascular and macrovascular complications of diabetes, which include the following: cardiovascular disease, neuropathy, nephropathy, retinopathy, and others. Patients with poor adherence are more likely to experience complications.2 A cohort study of type 2 diabetic patients showed that poor adherence led to statistically significant increases in A1c, blood pressure, and low-density lipoprotein (LDL). These patients had poorer outcomes with a 58% increased risk for all-cause hospitalization and 81% increased risk for all-cause mortality.

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Association of Neighborhood Walkability in Overweight, Obesity, and Diabetes

Hilary T. Box, PharmD- Mercer University College of Pharmacy

The National Health and Nutrition Examination Survey estimated that 69% of US adults were overweight or obese in 2011-2012 resulting in an increase in diabetes prevalence from 15% in the late 1970’s.1-2 Diabetes prevalence has increased from less than 4% in 1990 to 8.3% in 2012.3-4 It is thought that neighborhoods have shifted towards sprawling, car-oriented communities that discourage walking with heavy reliance on motorized transportation. However, it has been shown that neighborhoods with high population density, well-connected streets, and high number of destinations within walking distance of residential areas have higher rates of walking and bicycling for transportation.5-6

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Excess Mortality among Persons with Type 2 Diabetes

Sarah Vo, Mercer University College of Pharmacy

The prevalence of diabetes is suggested to have increased over the past two decades and is expected to affect more than 500 million adults by 2030, with most being type 2 diabetes. [1]

According to the World Health Organization, type 2 diabetes results from the body’s ineffective use of insulin.  With time, it is said that diabetes can damage the heart, blood vessels, eyes, kidneys, and nerves. [2]

According to the American Diabetes Association, diabetes remains the seventh leading cause of death in the United States in 2010.  Complications or co-morbid conditions associated with diabetes are said to include hypertension, cardiovascular disease, and dyslipidemia. [3]

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