Table 5: Evidence for the use of the basal-plus strategy.
Trial | Duration & Population Size | Intervention | Target HbA1c | Results |
1.2.3 study [36] | 24 weeks
115 subjects vs. 113 subjects |
Insulin glargine + OHA's + once daily insulin glulisine vs. insulin glargine + OHA's + twice daily insulin glulisine |
< 7% | • Proportion achieving target HbA1c: 30% vs. 33%
• Severe hypoglycaemia 0.28 vs. 0.89 events/patient year • Weight change + 3.8 vs. + 4.1 kg |
Stepwise [18] | 48 weeks
150 subjects vs. 146 subjects |
Insulin detemir + OHA's + stepwise aspart to largest meal (based on premeal glucose): Simple STEP vs. Insulin detemir + OHA's + stepwise aspart to largest meal (based on post-meal glucose) Extra STEP |
< 7% | • Proportion achieving target HbA1c: 31% vs. 27%
• Severe hypoglycaemia 0.04 vs. 0.01 events/patient year • Weight change + 2.7 vs. + 2.0 kg |
All to target [37] | 60 weeks
192 subjects vs. 189 subjects vs. 191 subjects |
Twice daily premixed insulin + 2-3 OHA's vs. insulin glargine + once daily glulisine + 2-3 OHA's vs. insulin glargine + stepwise addition of insulin glulisine + 2-3 OHA's |
< 7% | • Proportion achieving target HbA1c: 39% vs. 49% vs. 45%
• Severe hypoglycaemia 0.02 vs. 0.1 vs. 0.2 events/patient year |