After enrollment, every participant followed an insulin and metformin regimen for three months. The patients were then randomized to continue taking insulin and metformin or begin the triple oral therapy regimen. All participants were checked monthly for the first four months, at six months after randomization, and every three months thereafter for three years. Of the 58 patients randomized, 24 of the insulin-treated group and 21 of the triple oral therapy group completed the study.

The researchers found that the patients taking insulin plus metformin had fewer low-blood-sugar, or hypoglycemic, events, gained less weight and reported high satisfaction with the insulin.

Dr. Lingvay said she hopes physicians use these findings as the rationale to offer insulin-metformin as the first, rather than last, line of defense.

Modern medicine uses insulin as a very effective and safe treatment tool, she said. With the new devices that we ™re using, giving yourself an insulin shot is not much harder than taking pills.

The data represent the first three years of a six-year study still under way at UT Southwestern. The next step, Dr. Lingvay said, is to begin analyzing how the insulin plus metformin and oral triple therapy regimens affect insulin production in beta cells.

Other UT Southwestern researchers involved in the study included Jaime Legendre, recipient of a Clinical Research Fellowship from the Doris Duke Charitable Foundation; Dr. Polina Kaloyanova, former fellow in endocrinology; Dr. Song Zhang, assistant professor of clinical sciences; and Beverley Adams Huet, assistant professor of clinical sciences.

The study was supported by Novo Nordisk Inc., the National Institutes of Health and the Doris Duke Charitable Foundation.

www.utsouthwestern/endocrinology