Table 1 Characteristics of the included studies
Study/year | Design | N | Age (years) | Time with DM (mean, years) | Comparison | Basal insulin | Treatment time | Outcomes |
|---|---|---|---|---|---|---|---|---|
Anderson et al. (1997) | Open, multicenter, crossover | 336 | 32.1 (mean) | 12 | LISPRO (right before meal) × REGULAR (30–45 min before meal) | NPH and Long-acting insulin analogue (Humulin U) | 12 months | Total hypoglycemia Postprandial glucose Glycated hemoglobin |
Annuzzi et al. (2001)a | Multicenter, crossover | 85 | 31 (mean) | 12 | LISPRO (right before meal) × REGULAR (30-45 min before meal) | NPH | 3 months | Total hypoglycemia Severe hypoglycemia Glycated hemoglobin Quality of life |
Brock Jacobsen et al. (2011) | Double blind, single center, crossover | 16 | From 18 to 60 | 1 | ASPART × REGULAR (both right before meal) | NPH | 2 months | Total hypoglycemia Nocturnal hypoglycemia Postprandial glucose Glycated hemoglobin Quality of life |
Cherubini et al. (2006) | Open, single center, parallel | 30 | 8.1 (mean) | 5.2 | ASPART (2 min before meal) × REGULAR (30 min before meal). Counting of carbohydrates | Glargine | 4.5 months | Total hypoglycemia Postprandial glucose Glycated hemoglobin |
Danne et al. (2007) | Open, multicenter, crossover | 26 | 5 (mean) | 1.8 | ASPART (right before meal) × REGULAR (30 min before meal) | NPH | 3 months | Total hypoglycemia Severe hypoglycemia Patient satisfaction |
Fairchild et al. (2000) | Open, single center, crossover | 35 | From 5 to 10 | 3.1 | LISPRO (right before meal) × REGULAR (30 min before meal) | NPH | 3 months | Total hypoglycemia Nocturnal hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin |
Ferguson et al. (2001) | Open, single center, crossover | 33 | 46 (mean) | 26 | LISPRO (right before meal) × REGULAR (30 min before meal) | NPH | 4.5 months | Total hypoglycemia Nocturnal hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin Quality of life |
Ford-Adams et al. (2003) | Multicenter, crossover | 23 | From 7 to 11 | Not provided | LISPRO × REGULAR | NPH | 4 months | Total hypoglycemia Nocturnal hypoglycemia Glycated hemoglobin |
Gale et al. (2000) | Double blind, multicenter, crossover | 93 | 35 (median) | 13 (median) | LISPRO × REGULAR (both right before meal) | NPH | 3 months | Total hypoglycemia Nocturnal hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin Quality of life |
Garg et al. (2005) | Open, multicenter, parallel | 860 | 40.3 (mean) | 20 | GLULISINE (0-15 min before meal) × REGULAR (30–45 min before meal) | Glargine | 3 months | Total hypoglycemia Nocturnal hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin |
Heller et al. (1999) | Open, multicenter, crossover | 165 | 38 (mean) | 16 | LISPRO (right before meal) × REGULAR (30 min before meal) | NPH | 4 months | Total hypoglycemia Nocturnal hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin |
Heller et al. (2004) | Double blind, multicenter, crossover | 155 | 35.7 (mean) | 2 | ASPART × REGULAR (both right before meal) | NPH | 4 months | Total hypoglycemia Severe hypoglycemia Nocturnal hypoglycemia Glycated hemoglobin |
Holcombe et al. (2002) | Open, multicenter, crossover | 463 | 14.9 (mean) | 6 | LISPRO (right before meal) × REGULAR (30–45 min before meal) | NPH | 4 months | Total hypoglycemia Nocturnal hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin Adverse event |
Holleman et al. (1997) | Open, multicenter, crossover | 199 | 35.4 (mean) | 13 | LISPRO (right before meal) × REGULAR (30 min before meal) | NPH | 3 months | Total hypoglycemia Nocturnal hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin Life quality |
Home et al. (1998) | Multicenter, crossover | 104 | 34 (mean) | 15 | ASPART X REGULAR (both right before meal) | NPH | 1Â month | Total hypoglycemia Severe hypoglycemia Postprandial glycemia Glycated hemoglobin |
Home et al. (2000), Bott et al. (2003), Home et al. (2006) | Open, multicenter, parallel | 1070 | 38 (mean) | 15 | ASPART (right before meal) × REGULAR (30 min before meal) | NPH | 6 months | Total hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin Life quality |
Jacobs et al. (1997) | Open, multicenter, crossover | 12 | 18 (mean) | Not provided | LISPRO (right before meal) × REGULAR (30 min before meal) | NPH | 1 month | Total hypoglycemia Nocturnal hypoglycemia Postprandial glucose Glycated hemoglobin |
Provenzano et al. (2001) | Open, multicenter, crossover | 12 | 28 (mean) | 12 | LISPRO × REGULAR (both right before meal) | Long-acting insulin | 168 days | Total hypoglycemia Nocturnal hypoglycemia Postprandial glucose Glycated hemoglobin |
Raskin et al. (2000) | Open, multicenter, parallel | 882 | 39.2 (mean) | 1.5 | ASPART (right before meal) × REGULAR (30 min before meal) | NPH | 6 months | Total hypoglycemia Severe hypoglycemia Glycated hemoglobin |
Tamas et al. (2001) | Open, multicenter, parallel | 423 | From 18 to 70 | 14 | ASPART (0 to 5 min before meal) × REGULAR (30 min before meal) | NPH | 16 months | Total hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin Life quality |
Tupola et al. (2001) | Open, multicenter, crossover | 29 | 6 (mean) | 3 | LISPRO (30 min after the patient started eating) × REGULAR (20 to 39 min before meal) | NPH | 3 months | Total hypoglycemia Glycated hemoglobin |
Vale et al. (2001) | Open, multicenter, parallel | 1.184 | 38.7 (mean) | 19.4 | LISPRO (right before meal) × REGULAR (30 min before meal) | NPH | 3 months | Total hypoglycemia Severe hypoglycemia Postprandial glucose Glycated hemoglobin |