Patients & Families

Pre-Diabetes/Type 2 Diabetes

Type 2 diabetes, the most common type of metabolic disease, is characterized by hormonal changes leading to insulin resistance, poor pancreatic function, and elevated blood sugar levels (hyperglycemia). Worldwide, there are nearly 400 million people living with type 2 diabetes1, including nearly 30 million in the United States.2 Type 2 diabetes is commonly preceded by pre-diabetes, a condition in which blood sugar levels are higher than normal due to insulin resistance, but not high enough to meet the criteria for a diagnosis of diabetes.

Some people with type 2 diabetes can effectively manage their disease through lifestyle changes, such as by following a healthier diet and doing more exercise. However, most people with type 2 diabetes will require lifelong treatment with antidiabetic medications to try to keep their blood sugar under control. Over the course of the disease, most people will increase the number and dosage of their antidiabetic medications, and may eventually progress to requiring insulin or other injections to manage their blood sugar.

Unfortunately, antidiabetic medications do not directly address insulin resistance, one of the underlying cause of type 2 diabetes.3-8

In addition, despite broad access to many classes of oral medications and insulin therapy, nearly 50% of patients who are diagnosed with type 2 diabetes in the United States and Europe will have poor blood sugar control.9,10 Poor control leads to chronically high blood sugar levels, which can result in damage to the large blood vessels, kidneys, eyes, and nerves, putting patients at high risk of serious diabetic complications—including cardiovascular disease, kidney failure, blindness, and amputations.

Approximately 50% of patients with type 2 diabetes in the U.S. have poor glucose control despite medication usage.

Diabetes costs the U.S. healthcare system approximately $245 billion annually11, of which an estimated 75% is spent on costs associated with complications stemming from poor control of the disease. These costs are expected to rise dramatically as the population ages and more people develop type 2 diabetes.

Additional resources and information on pre-diabetes and type 2 diabetes for patients, families and caregivers are available from organizations including:

Fractyl is developing Revita™ DMR as a new approach to type 2 diabetes treatment. Revita™ DMR is an investigational, minimally invasive procedure designed to improve glycemic control and help alleviate the daily burden of type 2 diabetes management.

Revita™ DMR is currently being investigated in global clinical trials. For more information on clinical trials of Revita™ DMR, please visit www.clinicaltrials.gov and use the search term “Fractyl.”

See pre-diabetes/type 2 diabetes references

1International Diabetes Federation. Diabetes Atlas 2014. Available at: https://www.idf.org/diabetesatlas.
2American Diabetes Association. Statistics about Diabetes. Available at: http://www.diabetes.org/diabetes-basics/statistics/.
3Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58(4):773-95.
http://doi.org/10.2337/db09-9028
4DeFronzo RA, Eldor R, Abdul-Ghani M. Pathophysiologic approach to therapy in patients with newly diagnosed type 2 diabetes. Diabetes Care.2013;36 Suppl 2:S127–38.
http://doi.org/10.2337/dcS13-2011
5Einhorn D, Reaven GM, Cobin RH, et al. American College of Endocrinology position statement on the insulin resistance syndrome. Endocrine Pract . 2003;9(3):237–52.
http://www.ncbi.nlm.nih.gov/pubmed/12924350
6Fong DS, Aiello L, Gardner TW, et al. Retinopathy in diabetes. Diabetes Care. 2003;27(Supplement 1):S84–S87.
http://doi.org/10.2337/diacare.27.2007.S84
7Gross JL, de Azevedo MJ, Silveiro SP, Canani LH, Caramori ML, Zelmanovitz T. Diabetic nephropathy: Diagnosis, prevention, and treatment. Diabetes Care. 2004;28(1):164–176.
http://doi.org/10.2337/diacare.28.1.164
8Ramlo-Halsted BA, Edelman SV. The natural history of type 2 diabetes: Practical points to consider in developing prevention and treatment strategies. Clinical Diabetes. 2000;18(2):80-84.
http://journal.diabetes.org/clinicaldiabetes/v18n22000/pg80.htm
9Banegas JR, et al. Achievement of treatment goals for primary prevention of cardiovascular disease in clinical practice across Europe: the EURIKA study. Eur Heart J. 2011;32(17):2143-52.
10Ali MK, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Achievement of goals in U.S. diabetes care, 1999–2010. N Engl J Med. 2013;368(17):1613-24.
http://doi.org/10.1056/NEJMsa1213829
11American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033-46.

NAFLD/NASH

Nonalcoholic steatohepatitis (NASH)—a severe type of nonalcoholic fatty liver disease (NAFLD)—is another common metabolic disorder. Like in type 2 diabetes, dietary fat and sugar play a role in the development of NASH.1 In patients with NASH, fat buildup in the liver leads to liver inflammation and damage. Insulin resistance is a key driver of this process.2-6 Approximately 50% of patients with NASH also have type 2 diabetes. There are no therapies specifically approved for NAFLD or NASH available today. Treatment recommendations primarily ask patients with NAFLD or NASH to try lifestyle interventions focused on weight loss, exercise, and dietary changes. Physicians may also treat co-existing metabolic disorders, like diabetes and dyslipidemia. In the United States, an estimated 80 million people are living with NAFLD, and about 30 million of them have progressed to NASH. Approximately 50% of patients with NASH (or 14 million Americans) have liver fibrosis and are at high risk of developing cirrhosis, liver failure, and hepatocellular carcinoma, a type of liver cancer. Patients with type 2 diabetes are at particularly high risk of progressing through the stages of NASH. Within the next five years, it is predicted that NASH will be the leading cause of liver failure and need for liver transplant in the United States.7 Additional resources and information on NAFLD/NASH for patients, families and caregivers are available from organizations including:

Fractyl is investigating the potential effect of Revita™ DMR on metabolic diseases, such as NASH. Revita™ DMR is an investigational, minimally invasive procedure designed to as a novel treatment to improve metabolic health.

Revita™ DMR is currently being investigated in global clinical trials. For more information on clinical trials of Revita™ DMR, please visit www.clinicaltrials.gov and use the search term “Fractyl.”

See NAFLD/NASH references

1Vos MB, Lavine JE. Dietary fructose in nonalcoholic fatty liver disease. Hepatology. 2013;57(6):2525–31.
http://doi.org/10.1002/hep.26299
2Asrih M, Jornayvaz FR. Metabolic syndrome and nonalcoholic fatty liver disease: Is insulin resistance the link? Mol Cell Endocrinol. 2015;418 Pt 1:55-65.
3Chitturi S, et al. NASH and insulin resistance: Insulin hypersecretion and specific association with the insulin resistance syndrome. Hepatology. 2002;35(2):373-9.
4Nguyen TA, Sanyal AJ. Pathophysiology guided treatment of nonalcoholic steatohepatitis. J Gastroenterol Hepatol. 2012;27 Suppl 2:58–64. http://doi.org/10.1111/j.1440-1746.2011.07018.x
5Pagano, et al. Nonalcoholic steatohepatitis, insulin resistance, and metabolic syndrome: further evidence for an etiologic association. Hepatology. 2002;35(2):367-72.
6Sanyal AJ. Mechanisms of disease: pathogenesis of nonalcoholic fatty liver disease. Nat Clin Pract Gastroenterol Hepatol. 2005;2(1):46–53.
http://doi.org/10.1038/ncpgasthep0084

7Wree A, Broderick L, Canbay A, Hoffman HM, Feldstein AE. From NAFLD to NASH to cirrhosis-new insights into disease mechanisms. Nat Rev Gastroenterol Hepatol. 2013;10(11):627–36.
http://doi.org/10.1038/nrgastro.2013.149