New class of drugs for type 2 diabetes

The oral medication can be used alone or with two other commonly used drugs to better control the disease.

By Susan J. Landers — Posted Nov. 6, 2006

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

The Food and Drug Administration approved Januvia, or sitagliptin phosphate, Oct. 17 for use in treating type 2 diabetes. The drug, the first in a new class known as DPP-4 inhibitors, operates by enhancing the body's own ability to lower blood sugar levels.

Another drug in the same class, Galvus, or vildagliptin, is now in the approval pipeline. The drug is a product of Novartis Pharmaceuticals.

Type 2 is the most common form of diabetes, accounting for about 90% to 95% of the nation's nearly 21 million cases, according to the American Diabetes Assn. That number is expected to grow as levels of obesity increase.

Januvia, manufactured by Merck & Co., is to be used, in addition to diet and exercise, either alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor) gamma agonist.

Trials will be conducted to determine the safety of its use with insulin or a sulfonylurea, said Mary Parks, MD, director of the FDA's Division of Metabolism and Endocrine Products, in a news briefing.

Possible side effects include upper respiratory tract infections, sore throat, and some gastrointestinal complaints such as diarrhea and nausea, Dr. Parks said.

Weight loss or gain, which are problems with some other diabetes medications, did not seem to be caused by Januvia, she added.

Taken once daily in tablet form, the drug works by blocking dipeptidyl peptidase-4, an enzyme that breaks down the proteins that trigger the release of insulin. The result should be better insulin release and better blood sugar control.

"Those patients who are unable to adequately manage their type 2 diabetes with lifestyle changes ... and who require medications now have a new product to help regulate their blood sugar levels," said Edward S. Horton, MD, director of clinical research at Joslin Diabetes Center and a professor of medicine at Harvard Medical School in Boston, in a statement. He is also an adviser to Merck for its diabetes clinical program.

The drug was examined in 2,719 people with type 2 diabetes in studies lasting from 12 weeks to longer than a year, according to the FDA. The studies demonstrated improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist. The price is expected to be about $5 a tablet.

Back to top



Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story

Read story


American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story

Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story

Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story

Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story

Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story

Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story

Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn