Patients newly diagnosed with type 2 diabetes may do better long term if they go on early, intensive insulin treatment instead of the standard route of using oral medication first, according to new research.
"Twelve weeks of intense insulin therapy followed by observation for a year was as good as oral therapy intensified every month for 15 months," says Jay Shubrook, DO, director of clinical research and diabetes services, Touro Universisty California in Vallejo. Two patients from each group dropped out before the study ended.
Both groups had good results in reducing blood sugar levels, Dr. Shubrook says. The A1C levels, a marker of blood sugar control over the previous two or three months, declined from 10.1 percent to 6.7 percent in the insulin group over the 15 months of follow up. The levels declined from 9.9 percent to 6.8 percent in the oral therapy group in the same time period. (In general, the American Diabetes Association suggests those with diabetes have an A1C of under 7 percent.)
Even though the results were similar between the two groups, Dr. Shubrook says early, intense insulin may provide additional benefits. It may protect the insulin-producing beta cells in the pancreas and perhaps allow patients to need only intermittent therapy in the long run.
"The theory we are proposing is maybe every three to five years, give intensive insulin therapy," he says. He presented the new research October 17th at the Osteopathic Medical Conference and Exhibition, the annual meeting of the American Osteopathic Association in Orlando. The study was funded by Sanofi-Aventis, which makes insulin. Dr. Shubrook has no ties to Sanofi other than the research grant.
Dr. Shubrook is not the first to suggest the approach. He cites research dating back to 2004. "The research waxes and wanes," he says. "I think it's coming into favor again."
Beta cells die or become non-functioning with type 2 diabetes, he says. The early insulin treatment may prod some into becoming functional again, he says. "We don't believe we are curing diabetes with this treatment," he emphasizes. "It is possible we are putting type 2 diabetes in remission."
Remission, he says, ''means you can go without treatment for at least a year, excluding lifestyle [measures]."
The idea of using insulin first runs counter to current guidelines from organizations such as the American Diabetes Association, which suggests meal planning, diet and exercise first, then oral medications to control blood sugar. Even so, Dr. Shubrook estimates that a half dozen to a dozen centers around the U.S. offer patients early treatment with insulin when warranted.
One fear, he says, is the complication of hypoglycemia or low blood sugar with intense insulin treatment. In his study, no one had severe hypoglycemia. Ten patients did report some low blood sugar, including 7 in the insulin group and 3 in the oral therapy group.
Oral agents in the study, which began in 2010, included metformin, glimepiride (Amaryl) and pioglitazone (Actos).
The reduction in blood sugars was ''impressive'' in both arms, says Luigi Meneghini, MD, executive director of the Global Diabetes Program, Parkland Health and Hospital System and professor of internal medicine at the University of Texas Southwestern Medical Center. He reviewed the findings.
"There have been about three or four studies showing that intensively treating with insulin versus oral medications in some way protects or preserves the function of the beta cells, the insulin-producing cells," he says. In those with type 2 diabetes, ''whatever beta cells they have in the pancreas are beaten down by all this high blood sugar and are not responding well," he says. "Many times by using insulin you can lower the blood sugar very effectively."
He adds, ''There is some evidence, although it is not very strong, that doing this early on, rapidly resolving this gluco-toxicity with insulin, might be healthier for beta cells in the long run."
One limitation of the new study, Dr. Meneghini says, is that it was done on medicines in favor when the study was done. Since then, newer drugs have become available, so the results might differ in an updated comparison, he says.