Final results

Results

The final 4-T results were presented during the "Latest clinical trials" symposium at the IDF World Diabetes Congress in Montreal, Canada on Thursday 22nd October 2009.

Download the slide set here.

Brief Overview

Patients who added a basal or prandial insulin-based regimen to oral therapy had better glycated haemoglobin control than patients who added a biphasic insulin-based regimen. Fewer hypoglycaemic episodes and less weight gain occurred in patients adding basal insulin.

The 4-T trial enrolled patients whose glycaemic control was inadequate despite therapy with two oral agents (metformin and sulfonylurea). They were assigned at random to receive biphasic insulin injections twice a day (biphasic insulin aspart 30, NovoMix 30®), prandial insulin injections three times a day (insulin aspart, NovoRapid®), or basal insulin injected once a day (insulin detemir, Levemir®), aiming to achieve glycated haemoglobin (HbA1c) levels of 6.5% or less. If after the first year of the trial their glycated haemoglobin levels remained above 6.5%, sulfonylurea therapy was stopped and a second type of insulin commenced. For those on biphasic insulin, once daily prandial insulin was added; for those on prandial insulin, once daily basal insulin was added; and for those on basal insulin, three times a day prandial insulin was added.

At three years the median glycated haemoglobin overall was 6.9% (7.1% in the biphasic arm, 6.9% in the basal arm and 6.8% in the prandial arm), with three-quarters (74.3%) patients taking two types of insulin. More patients commencing therapy with a basal (43.2%) or prandial (44.8%) insulin achieved glycated haemoglobin levels of 6.5% or less than those commencing with a biphasic insulin (31.9%). Weight gain over three years in those commencing with basal insulin was less (3.6 kg) than with biphasic insulin (5.7 kg) or prandial insulin (6.4 kg). In addition, those randomized to the basal insulin approach had fewer hypoglycaemic episodes (1.7 per patient per year) than the biphasic (3.0 per patient per year) or prandial (5.7 per patient per year) insulin approaches.

Full Results

These are published in the New England Journal of Medicine with an accompanying editorial.

4-T Office, Diabetes Trials Unit, OCDEM, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LJ
Tel: +44 (0)1865 857239     Fax: +44 (0)1865 857248    Email: 4-T@dtu.ox.ac.uk

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