ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Endocrine Abstracts (2006) 12 P50

Evidence for a safe switch from human premixed insulin to BIAsp 30 in twice-daily regimens – data from the REACH study

PG McNally1, S Page2, G Compion3 & J Lorains4


1Leicester Royal Infirmary, Leicestershire, United Kingdom; 2Nottingham University Hospitals NHS Trust, Nottinghamshire, United Kingdom; 3Novo Nordisk Ltd., West Sussex, United Kingdom; 4Clatterbridge Hospital, Merseyside, United Kingdom.


Aims

The premixed insulin analogue, biphasic insulin aspart 30/70 (BIAsp 30, 30% insulin aspart, 70% protaminated aspart) has a more physiological absorption profile than conventional premixed insulin, biphasic human insulin 30/70 (BHI 30, 30% soluble human insulin, 70% NPH), but no studies have previously tested how a switch from BHI 30 to BIAsp 30 can be done safely using a simple guideline. We investigated the occurrence of low interstitial glucose (IG) (using the MiniMed Continuous Glucose Monitoring System, CA, USA), and self-reported hypoglycaemia in patients with type 2 diabetes who switched unit-for-unit from BHI 30 BID to BIAsp 30 BID in the double-blind, randomised, controlled “REACH” study (reported elsewhere, approved by local Ethical Committee).

Methods

After an 8-week run-in for pre-treatment optimisation, patients with HbA1c 6.5–8.5% entered a 32-week, two-period, randomised, crossover trial. Patient groups included in this sub-analysis were: A–those who received BHI 30 during the run-in followed by BIAsp 30 in period 1; B–those who received BHI 30 in period 1, followed by BIAsp 30 in period 2. IG data were recorded every 10 s for 3 days in the middle and end of each treatment period and grouped into episodes: sets of continuous low IG readings (<2.5 and <3.5 mmol/l), allowing two consecutive readings above threshold (the start of successive episodes ≥1 h apart). Data are shown for groups A, B and A+B.

Results

There was a general reduction in episodes of low IG and self-reported hypoglycaemia when switching from BHI 30 to BIAsp 30, but none were statistically significant (Table).

Patient group switching from BHI 30 to BIAsp 30
Δ Number of episodes after switch (mean ±S.D.)A (n=39)B (n=73)A+B (n=112)
IG <3.5 mmol/l−1.51±5.12−0.48±4.45−0.84±4.70
IG <2.5 mmol/l−1.03±3.29−0.12±2.69−0.44±2.93
Self-reported hypoglycaemia0.48±17.68−0.50±18.46−0.15±18.12

Conclusion

Switching from BHI 30 to BIAsp 30 can be done safely unit-for-unit.

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