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Starlix (Nateglinide) Reduces Diabetic Spikes in Real-World Study: Presented at ADA

By Bruce Sylvester
Special to DG News

SAN FRANCISCO, CA -- June 17, 2002 -- A real-world study indicates that Starlix (nateglinide) used as monotherapy or with metformin, reduces spiking of after-meal blood glucose levels in adults with type 2 diabetes, improving overall blood glucose control.

Researchers reported the findings here Saturday at the annual meeting of the American Diabetes Association (ADA).

"The current belief is that you cannot effectively lower hemoglobin A1c unless you address the elevations or spikes in glucose that happen after a meal," said lead investigator Michelle Baron, MD, clinical researcher at Novartis Pharmaceuticals in East Hanover, New Jersey. "Patients who have diabetes also have problems with elevated glucose at mealtime."

"By reducing that mealtime glucose elevation you can control the overall, aggregate hemoglobin A1c averages," she added. "By lowering the post-prandial spikes, you are able to effectively control blood glucose in patients who have never been treated before and who take nateglinide as a monotherapy, or in patients who are on an agent for diabetes and who need additional control. We looked at these two patient populations."

"This study takes what we know about the efficacy of Starlix in clinical trials to where it matters most -- a real-world setting," said Ken Hershon, MD, director of research, Northshore Diabetes and Endocrine Associates, Long Island, New York. "Here, we found that Starlix significantly reduced mealtime glucose spikes and overall blood glucose in practice just as well as it did in controlled clinical trials."

The findings come from a 12-week, multi-center, office-based, open-label study involving 141 subjects, 58 who were poorly controlled by diet and 83 who were poorly controlled on metformin (Group 2). The researchers used standardized tests to measure blood glucose levels before administering nateglinide and at the end of the study.

The researchers found that treatment with nateglinide lowered overall HbA1c levels by 1.1 percent in drug-naļve patients with Type 2 diabetes (p<0.001). It reduced HbA1c by 0.8 percent in patients whose diabetes was inadequately controlled by metformin (p<0.001).

"It is important for people with diabetes to understand that every reduction in blood glucose levels is beneficial," Dr. Hershon said. "Some studies suggest that for every percent reduction in HBA1c, there is a corresponding 25 percent reduction in the cardiovascular health risks associated with diabetes."

American College of Endocrinology guidelines indicate that diabetics should maintain overall HbA1c at 6.5 percent or lower, and post-prandial glucose levels (PPG) below 140/mg/dL.

In this study, nateglinide reduced both mealtime glucose spikes (PPG) and overall HbA1c. Drug-naļve patients had mealtime glucose level reductions from a mean of 195 to 150 mg/dL (p<0.001) and HbA1c scores reduced from an average of 8.2 percent to 7.1 percent (p<0.001). Patients taking metformin saw their mealtime glucose levels drop from a mean of 209 to 160 mg/dL (p<0.001), and HbA1c scores dropped from an average of 8.2 percent to 7.4 percent (p<0.001).

The subjects showed a high response rate to nateglinide, with 77.6 percent of the drug-naļve patients and 69.9 percent of the metformin patients achieving HbA1c reductions of 0.5 percent or greater.

Nateglinide was well tolerated. The most common adverse events were mild symptoms of hypoglycemia. Confirmed hypoglycemia (plasma glucose < 60 mg/dL) happened in 4.4 percent of the drug naļve patients and in 2.9 percent of the metformin.

"These results are encouraging because of what they mean to patients in the real-world," Dr. Hershon said. "Whether you are newly diagnosed with type 2 diabetes or treating your condition with metformin, adding Starlix can help you get to healthier blood glucose goals."

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