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