medwireNews: Many children who require insulin treatment on diagnosis with Type 2 diabetes can be weaned off the medication, show findings from the run-in phase of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.
Of the 330 participants who were taking insulin when screened, only 11% could not be weaned from the drug, and therefore did not enter the main study, and some of these patients had other reasons for not completing the full run-in phase, such as failure to attend study visits.
None of the patients who were weaned off insulin had metabolic decompensation or ketoacidosis.
“While approximately half of these youth eventually required re-initiation of insulin due to rising HbA1c [glycated haemoglobin] later in the course of the disease, it is just as important to note that the other half of participants in TODAY maintained durable metabolic control without the addition of insulin”, say Laura Pyle (George Washington University, Rockville, Maryland, USA) and co-researchers.
“Therefore, these data support early weaning of insulin to avoid overtreatment of those who will maintain control on oral therapy.”
The previously reported primary results of TODAY established that about half of the 699 patients who entered the main study achieved lasting glycaemic control with metformin, with rates further improved in those also given rosiglitazone. The current analysis involves 814 patients who completed at least 8 weeks of the run-in phase, during which they received diabetes education and metformin dose titration.
Notably, the median HbA1c level of these patients fell by a significant 0.7% during the run-in period, and the proportion whose levels were above 7.5% fell from 40.8% to 11.4%. Despite the short period, the participants also had small but significant improvements in body mass index z-score, total and low-density lipoprotein cholesterol levels, triglycerides and blood pressure.
Consequently, the proportion meeting the definition for the metabolic syndrome fell from 65.8% to 59.8%.
The largest improvements in HbA1c levels were seen among patients who were taking insulin at baseline, but this difference was due to variation in baseline HbA1c levels, which were higher among patients taking insulin as opposed to metformin alone or no medication.
Indeed, in regression analyses, baseline HbA1c level had “by far the greatest effect size” on HbA1c changes during the run-in phase.
“Taken together, the results of TODAY screening, run-in, and primary outcome suggest that most youth can be initially treated successfully with metformin alone and that, when insulin is initially required due to elevated HbA1c, insulin therapy can be brief and weaned rapidly”, write the researchers in Pediatric Diabetes.
By Eleanor McDermid, Senior medwireNews Reporter
Pediatr Diabetes 2015; Advance online publication
medwireNews is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2015