A combination of two diabetes drugs is more effective than one in treating 10-17-year-olds recently diagnosed with type 2 diabetes, according to researchers at Washington University in St. Louis who participated in a multicenter clinical trial funded by the National Institutes of Health (NIH).
The Washington University School of Medicine segment of the trial was led by Neil H. White, MD, professor of pediatrics and of medicine and director of the Pediatric Clinical Research Unit and a diabetes specialist at St. Louis Children’s Hospital.
The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study is the first major comparative effectiveness trial for the treatment of type 2 diabetes in young people using the diabetes drugs metformin and rosiglitazone. Results of the study appeared April 29 in the New England Journal of Medicine.
The study is the largest to date to provide information about the serious nature of type 2 diabetes in youth and to compare the efficacy of the available treatments, White says.
“The results suggest that even in youth who appear to have mild type 2 diabetes, early aggressive intervention is necessary to achieve the control needed to prevent the devastating health consequences of type 2 diabetes, such as coronary artery disease, stroke, kidney and eye disease and nerve damage,” White says. “The impact of these health consequences is clear in adults, but when they manifest at a younger age the personal and societal impact will be even greater.”
Results showed that metformin therapy alone was not an effective treatment for many of these youth. In fact, metformin had a much higher failure rate in study participants than has been reported in studies of adults treated with metformin alone. In addition, adding an intensive lifestyle intervention to metformin provided no more benefit than metformin therapy alone.
The study enrolled 699 youth aged 10-17 who had type 2 diabetes for less than two years and a body mass index at the 85th percentile or greater. The researchers looked at how well and for how long each of three treatment approaches controlled blood glucose levels. Participants were randomly assigned to receive metformin alone; metformin and rosiglitazone together; or metformin plus intensive lifestyle changes aimed at helping participants lose weight and increase physical activity.
The researchers found that treatment with metformin alone was inadequate for maintaining acceptable, long-term, blood glucose control in 51.7 percent of youth over an average follow-up of 46 months. The failure rate was 38.6 percent in the metformin and rosiglitazone group, a 25.3 percent reduction from metformin alone. In the metformin plus lifestyle group the failure rate was 46.6 percent.
Currently, metformin is the standard treatment for young people with type 2 diabetes and the only oral drug approved for this use by the U.S. Food and Drug Administration.
The longer a person has type 2 diabetes, the greater the likelihood of developing complications, making it critical for youth with type 2 diabetes to quickly achieve and sustain control of their blood glucose.
“The continued follow-up of these subjects will be an important component of determining the long-term impact of diabetes-related complications and heart disease and the benefits and risks of early intervention,” White says.
Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked sixth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.
Study centers included: Children’s Hospital Los Angeles; Children’s Hospital Colorado, Aurora; University of Oklahoma Health Sciences Center, Oklahoma City; The University of Texas Health Science Center at San Antonio; Texas Children’s Hospital, Baylor College of Medicine, Houston; Washington University School of Medicine in St. Louis; Saint Louis University Health Sciences Center, St. Louis; Rainbow Babies & Children’s Hospital, Cleveland; Children’s Hospital of Pittsburgh; Children’s Hospital of Philadelphia; Joslin Diabetes Center at SUNY Upstate Medical University, Syracuse, NY; Yale University, New Haven, Conn.; Massachusetts General Hospital, Boston; Joslin Diabetes Center, Boston; Berrie Center at Columbia University, New York City; Data Coordinating Center at George Washington University, Washington, D.C.
The TODAY study was funded by the National Institute of Digestive and Kidney Diseases, BD Bristol-Myers Squibb, Eli Lilly and Co., GlaxoSmithKline, LifeScan Inc., Pfizer Inc. and Sanofi-aventis.