Blog | Wednesday, May 2, 2012

QD: News Every Day--Teens with type 2 diabetes likely to need combination therapy sooner

A majority of teenagers with type 2 diabetes may require combination treatment or insulin therapy within a few years of diagnosis, researchers concluded.

The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study was a multicenter, randomized clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases. It compared glycemic control of metformin monotherapy to metformin/rosiglitazone and metformin/lifestyle intervention.

Eligible patients 10 to 17 years of age were treated with 1,000 mg twice daily metformin to achieve A1c levels less than 8% and then randomized to one of the three arms. The primary outcome was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for 6 months or sustained metabolic decompensation requiring insulin.

Results were published April 29 at the New England Journal of Medicine.

Of the 699 randomly assigned participants, 319 (45.6%) reached the primary outcome over an average follow-up of 3.86 years. Rates of failure were 51.7% (120 of 232 participants), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone, metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively.

Metformin plus rosiglitazone was superior to metformin alone (P=0.006); metformin plus lifestyle intervention was intermediate but not significantly different from metformin alone or metformin plus rosiglitazone.

Percent overweight was calculated to examine change in the critical first 6 months of treatment administration, when weight-loss interventions typically have their greatest effect. The average change in percent overweight at 6 months was -1.42 percentage points for metformin alone, 0.81 percentage points for metformin plus rosiglitazone, and -3.64 percentage points for metformin plus lifestyle intervention (P less than 0.001 for the overall comparison; all three pairwise comparisons were also significant).

At 24 months, metformin plus rosiglitazone (0.89 percentage points) was still significantly different from both metformin alone (-4.42 percentage points) and metformin plus lifestyle intervention (-5.02 percentage points) (P less than 0.001 for both comparisons with metformin plus rosiglitazone), but metformin alone was not significantly different from metformin plus lifestyle intervention.

A reduction of at least 7 percentage points in percent overweight was considered meaningful, the authors wrote. The proportion of participants with such a reduction at 6 months was significantly higher in the metformin-plus-lifestyle group (31.2%) than in the metformin-plus-rosiglitazone group (16.7%, P less than 0.001) but did not differ significantly from the proportion in the metformin-alone group (24.3%).