Abstract
Objective. To assess the effect of substitution of early insulin release with a small weight‐based dose of the rapid acting insulin analogue, insulin Aspart (IAsp), on postprandial hyperglycaemia in patients with recently diagnosed type 2 diabetes. Material and methods. In a randomized, double‐blind, double‐dummy design, 20 patients underwent three 3‐day periods with injection of IAsp 0.06 IU/kg BW or placebo 30 min before main meals. The effect on blood glucose fluctuations was evaluated using a continuous glucose monitoring system. Efficacy endpoints were time with glucose values above 8 mmol/L and glucose area above 8 mmol/L; safety endpoint was time with glucose values below 4 mmol/L in the last 24 h in the treatment periods. Results. IAsp significantly reduced the duration of blood glucose values above 8 mmol/L compared with placebo during 24 h (8.1±1.4 h versus 12.7±1.3 h), (p<0.03). Glucose areas above 8 mmol/L were 0.6±0.2 mmol/lxh and 1.2±0.2 mmol/lxh for IAsp and placebo, respectively (p<0.001). Two patients (one in each of the IAsp and placebo periods) had two asymptomatic episodes of glucose registration below 4 mmol/L. Patients with HbA1c below 7.4 % obtained the greatest reduction in duration of blood glucose values above 8 mmol/L, whereas the decrease in blood glucose increments for patients with HbA1c above 7.4 % was not significantly different from placebo. Conclusions. A fixed dose of IAsp injected 30 min before mealtimes reduced the postprandial glucose increment in patients with recently diagnosed type 2 diabetes without the risk of hypoglycaemia. Glucose fluctuations in patients with HbA1c below 7.4 % improved to near normal level.
Acknowledgements
We thank Svend Hansen, MedTronic Minimed, for lending us the CGMS monitors; Lene Moerk, Abbort Laboratory A/S, for supplying the Precision Xceed for SMBG; and Novo Nordisk A/S for supplying study medicine. ClinicalTrial.gov no. NCT00254085. Competing interests: Two of the authors are now employed in Novo Nordisk A/S, AD and AMR.