Date Published: 25 January 2013

FDA approves Nesina, Kazano, and Oseni for type 2 diabetes

Health News from the United States of America (USA)

Health News from the United States of America (USA)

In a recent statement on its website the United States Food and Drug Administration (FDA) has provided information about its new approval of the three new drug treatments Nesina, Kazano, and Oseni for type 2 diabetes. These 3 drug treatments have been approved for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes:

  • Nesina (alogliptin) tablets,
  • Kazano (alogliptin and metformin hydrochloride) tablets, and
  • Oseni (alogliptin and pioglitazone) tablets.

Alogliptin is a new active ingredient, while metformin hydrochloride and pioglitazone are already FDA-approved for the management of type 2 diabetes. As the most common form of the disease, type 2 diabetes affects about 24 million people and accounts for more than 90% of diabetes cases diagnosed in the United States.

People with type 2 diabetes are either resistant to insulin or do not produce enough insulin, resulting in high blood sugar levels. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

" Controlling blood sugar levels is very important in the overall treatment and care of diabetes," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.
" Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."

Nesina, Kazano, and Oseni were studied as stand-alone therapies (monotherapies) and in combination with other type 2 diabetes therapies, including sulfonylureas and insulin. They should not be used to treat people with type 1 diabetes or those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Information made available by the FDA includes:

About Nesina

Nesina was demonstrated to be safe and effective in 14 clinical trials involving about 8,500 patients with type 2 diabetes.

  • Nesina resulted in reductions in glycosylated hemoglobin (HbA1c), a measure of blood sugar control, of 0.4% to 0.6% compared with placebo after 26 weeks of use.
  • The FDA is requiring five postmarketing studies for Nesina: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and three pediatric studies under the Pediatric Research Equity Act (PREA), including a dose finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin.
  • The most common side effects of Nesina are stuffy or runny nose, headache, and upper respiratory tract infection.

About Kazano

The safety and efficacy of Kazano were demonstrated in four clinical trials involving more than 2,500 patients with type 2 diabetes.

  • Kazano resulted in additional reductions in HbA1c of 1.1% over Nesina and 0.5% over metformin after 26 weeks of use.
  • The FDA is requiring two postmarketing studies for Kazano: an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and a pediatric safety and efficacy study under PREA.
  • Kazano carries a Boxed Warning for lactic acidosis, a build-up of lactic acid in the bloodstream, associated with metformin use.
  • The most common side effects of Kazano are upper respiratory tract infection, stuffy or runny nose and sore throat, diarrhea, headache, high blood pressure, back pain, and urinary tract infection.

About Oseni

Oseni was demonstrated to be safe and effective in four clinical trials involving more than 1,500 patients with type 2 diabetes.

  • Oseni resulted in additional reductions in HbA1c of 0.4% to 0.6% over pioglitazone monotherapy and 0.4% to 0.9% over alogliptin monotherapy.
  • The FDA is requiring an enhanced pharmacovigilance program for Oseni to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions.
  • Oseni carries a Boxed Warning for heart failure associated with pioglitazone use.
  • The most common side effects of Oseni are stuffy or runny nose and sore throat, back pain, and upper respiratory infection.

Further information is available from the FDA's website.

Source: The U.S. Food and Drug Administration
http://www.fda.gov -

Also in the News:

Health uses of the drumstick tree (India) - 2 May '16

AMA endorses 2015-2020 Dietary Guidelines (USA) - 8 Jan '16

Vet charity warning about pet obesity - 25 Mar '15

Ageing: Diabetes and depression predict dementia risk - 20 Feb '15

New: Mobile medical apps for continuous glucose monitoring - 23 Jan '15

Increasing daily coffee consumption may reduce risk of type 2 diabetes - 24 Apr '14

Insulin use to treat type 2 diabetes trebles - 7 Feb '14

Does vitamin D prevent diabetes ? - 21 Oct '13

Angels encourage us to develop mental, spiritual and emotional clarity.

Although care has been taken when compiling this page, the information contained might not be completely up to date. Accuracy cannot be guaranteed. This material is copyright. See terms of use.

IvyRose Holistic 2003-2019.