Januvia, a new generation diabetes medicine made by Merck & Co, was found to help lose weight and better control hypoglycemia in patients with type 2 diabetes. Its efficacy in controlling blood glucose levels was comparable to another diabetes drug Glipizide, Merck says in a statement released June 13.
Results from an ongoing study showed Januvia was non-inferior to Glipizide in significantly reducing blood glucose levels at 52 weeks when added to patients with type 2 diabetes who had inadequate control on metformin monotherapy. The study will continue for another year.
"In the new data presented today, JANUVIA demonstrated substantial glucose-lowering effects at one year with a magnitude of A1C reduction that was non-inferior to that of glipizide. Additionally, JANUVIA demonstrated weight loss and fewer episodes of hypoglycemia vs. glipizide," said Peter Stein, M.D., senior director, clinical research, Merck & Co., Inc.
"These are important findings for a potential new treatment for type 2 diabetes," he said.
Januvia is an investigational once-daily medicine that belongs to a new class of oral drugs (dipeptidyl peptidase-4 (DPP-4) inhibitors), which lowers elevated blood sugar levels in type 2 diabetics by enhancing their body’s ability to digest blood glucose.
Merck said if approved the new medicine could be the first in the new class of oral-administered DDP-4 inhibitors which function differently from currently available classes of blood sugar lowering agents used by diabetics.
Glipizide is also used to treat type 2 diabetes, particularly in those whose blood sugar cannot be controlled by diet alone. It reduces blood sugar levels by stimulating the pancreas to secrete insulin and help the body to use insulin more efficiently.
In the double-blind, randomized study, 793 diabetics were assigned 100 mg of Januvia once daily or Glipizide up to 20 mg daily.
As a result, each group experienced reductions in A1C by 0.67 percent from baseline (on average 7.5 percent ranging from 6.5 to 10 percent), according to Merck. At 52 weeks, 63 percent of patients on Januvia achieved A1C goal (less than 7 percent), compared to 59 percent in the Glipizide group.
A1C is a measure of a person's blood glucose over a two- to three-month period.
"In the 52-week data, JANUVIA was generally well tolerated. No significant safety concerns for JANUVIA were apparent based on review of overall incidence of adverse experiences (AEs), incidence of hypoglycemia or gastrointestinal AEs, mean changes and predefined limits of change in laboratory safety parameters and ECG data and vital signs," Merck states in a press release.
One advantage of Januvia over Glipizide is that at 52 weeks, patients on 100 mg once daily of Januvia experience significant weight loss (1.5 kilograms) while patients treated with Glipizide gained 1.1 kg on average.
"Additionally, patients treated with glipizide experienced a significantly higher rate of hypoglycemia (when b lood sugar is too low) vs. Januvia (patients experiencing at least one hypoglycemic episode regardless of severity: 32.0% vs. 4.9%, respectively," according to Merck.
Overall, the incidence of clinical and laboratory adverse experiences was similar in both the Januvia and Glipizide groups. The incidence of hypoglycemia was 1.2 percent in patients who used 100 mg Januvia, 0.9 percent in the 200 mg Januvia group and 0.9 percent in the placebo group.
Weight loss in patients on Januvia was not associated with clinically significant change compared to placebo.
The most common adverse effects observed more often (3 percent higher) in the Januvia group include stuffy or runny nose, sore throat, headache, diarrhea, upper respiratory infection, joint pain, and urinary tract infection.
What is type 2 diabetes?
Diabetes is a disease in which blood glucose levels are above normal. Diabetics have problems converting food to energy. After a meal, food is broken down into a sugar called glucose, which is carried by the blood to cells throughout the body. Cells use the hormone insulin, made in the pancreas, to help them process blood sugar into energy.
People develop type 2 diabetes because the cells in the muscles, liver, and fat do not use insulin properly. Eventually, the pancreas cannot make enough insulin for the body’s needs. As a result, the amount of sugar in the blood increases while the cells are starved of energy. Over the years, high blood sugar damages nerves and blood vessels, leading to complications such as heart disease, stroke, blindness, kidney disease, nerve problems, gum infections, and amputation.
The results of the Januvia study were reported June 13 at the American Diabetes Association (ADA) 66th Annual Scientific Session.
