Treating To Target in Type 2 Diabetes
The 4-T One-Year results were presented as a "late breaking trial" at the 43rd EASD meeting in Amsterdam on 21st September 2007.
Download the full slide set here.
The Treating To Target in Type 2 Diabetes (4-T) study is an open-label, three-year, randomised controlled trial in 58 UK and Irish centres comparing the efficacy and safety of three analogue insulin regimens in 708 patients with type 2 diabetes inadequately controlled on maximally tolerated sulphonylurea and metformin therapy. Patients with a suboptimal HbA1c level (7.0 to 10.0%) were assigned at random to receive biphasic insulin aspart twice daily, prandial insulin aspart three times daily, or basal insulin detemir once daily (twice if required). At one year, mean HbA1c levels were similar (P = 0.08) in the biphasic group (7.3%) and the prandial group (7.2%), but higher in the basal group (7.6%, P<0.001 for both comparisons). The respective proportions of patients with an HbA1c level of 6.5% or less were 17.0%, 23.9%, and 8.1%; respective mean numbers of hypoglycemic events per patient per year were 5.7, 12.0, and 2.3; and respective mean weight gains were 4.7 kg, 5.7 kg, and 1.9 kg. Rates of adverse events were similar among the three groups.
The one-year results show that a single analogue-insulin formulation added to metformin and sulfonylurea resulted in an HbA1c level of 6.5% or less in a minority of patients at one year. The addition of biphasic or prandial insulin aspart reduced levels more than the addition of basal insulin detemir, but were associated with greater risks of hypoglycemia and weight gain. This first year of the three-year 4-T study suggests that most patients are likely to need more than one type of insulin to achieve target glucose levels. The final two years of the trial will examine specifically the use of complex insulin regimens in these patients.