Characteristics of the randomized controlled trials included in the meta-analysis
| Trials (first author, year) . | N . | Mo . | Insulin regimen . | Design analog (shot/day) . | Age(years) . | Male (%) . | OHAs . | < /≤ 7% . | Naïve . | Start HbA1c . | Titration . | Statistics . | Quality score . | Insulin dose (units/kg) . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Malone, 2004 (23) | 105 | 4 | Biphasic | CO Lispro25 (×2) | 55.3 | 62.3 | 8.7% | 0.62 | ||||||
| Basal | Glargine | 55.3 | 62.3 | Met | ≤ | Yes | 8.7% | No | No ITT | 3 | 0.57 | |||
| Malone, 2005 (24) | 97 | 4 | Biphasic | CO Lispro25 (×2) | 59.3 | 42 | 8.5% | 0.42 | ||||||
| Basal | Glargine | 59.3 | 42 | Met | ≤ | No | 8.5% | No | ITT | 2 | 0.28 | |||
| Raskin, 2005 (25) | 233 | 6 | Biphasic | P Aspart30 (×2) | 52.6 | 53 | 9.7% | 0.82 | ||||||
| Basal | Glargine | 52.3 | 57 | Met + Pio | < | Yes | 9.8% | Yes | ITT | 2 | 0.55 | |||
| Kann, 2006 (26) | 255 | 6 | Biphasic | P Aspart30 (×2) | 61.5 | 53.9 | 9.2% | 0.39 | ||||||
| Basal | Glargine | 61 | 48.8 | Glimepiride | < | Mix | 8.9% | No | ITT | 2 | 0.39 | |||
| Jacober, 2006 (27) | 60 | 4 | Biphasic | CO Lispro50 (×2) + Lispro25 | 54.9 | 56.7 | 9.2% | 0.35 | ||||||
| Basal | Glargine | 54.9 | 56.7 | Met/Su/Tzd | ≤ | Yes | 9.2% | No | No ITT | 2 | 0.28 | |||
| Kazda, 2006 (28) | 107 | 6 | Biphasic | P Lispro50 (×3) | 59.4 | 54 | 8.1% | 0.59 | ||||||
| Basal | Glargine | 59.4 | 54 | No | < | Yes | 8.1% | No | ITT | 2 | 0.43 | |||
| Kazda, 2006 (28) | 106 | 6 | Biphasic | P Lispro50 (×3) | 59.4 | 54 | 8.1% | 0.59 | ||||||
| Prandial | Lispro (×3) | 59.4 | 54 | No | < | Yes | 8.2% | No | ITT | 2 | 0.50 | |||
| Kazda, 2006 (28) | 105 | 6 | Prandial | P Lispro (×3) | 59.4 | 54 | 8.2% | 0.50 | ||||||
| Basal | Glargine | 59.4 | 54 | No | < | Yes | 8.1% | No | ITT | 2 | 0.43 | |||
| Holman, 2007 (29) | 469 | 12 | Biphasic | P Aspart30 (×2) | 61.7 | 64.1 | 8.6% | 0.53 | ||||||
| Basal | Detemir | 61.7 | 64.1 | Met + Su | ≤ | Yes | 8.4% | Yes | ITT | 4 | 0.49 | |||
| Holman, 2007 (29) | 474 | 12 | Biphasic | P Aspart30 (×2) | 61.7 | 64.1 | 8.6% | 0.53 | ||||||
| Prandial | Aspart (×3) | 61.7 | 64.1 | Met + Su | ≤ | Yes | 8.6% | Yes | ITT | 4 | 0.61 | |||
| Holman, 2007 (29) | 472 | 12 | Prandial | P Aspart (×3) | 61.7 | 64.1 | 8.6% | 0.61 | ||||||
| Basal | Detemir | 61.7 | 64.1 | Met + Su | ≤ | Yes | 8.4% | Yes | ITT | 4 | 0.49 | |||
| Robbins, 2007 (30) | 315 | 6 | Biphasic | P Lispro50 (×3) | 57.7 | 49.8 | 7.8% | 0.7 | ||||||
| Basal | Glargine | 57.7 | 49.8 | Met | ≤ | No | 7.8% | Yes | ITT | 4 | 0.6 | |||
| Bretzel, 2008 (31) | 418 | 10.5 | Prandial | P Lispro (×3) | 59.7 | 59 | 8.7% | 0.53 | ||||||
| Basal | Glargine | 60 | 52 | Met, Su | ≤ | Yes | 8.7% | Yes | ITT | 4 | 0.50 | |||
| Hirao, 2008 (32) | 117 | 6 | Biphasic | P Aspart30 (×2) | 58.5 | 58.7 | 10.6% | — | ||||||
| Prandial | Lispro (×3) | 57.9 | 61.2 | No | < | Yes | 10.6% | No | No ITT | 2 | — | |||
| Rosenstock, 2008 (33) | 374 | 6 | Biphasic | P Lispro50 (×3) | 55.4 | 53 | 8.8% | 1.2 | ||||||
| Basal-bolus | Lispro (×3) + Glargine | 54 | 52 | No Su | < | No | 8.9% | Yes | Complete | 3 | 1.4 | |||
| Liebl, 2009 (34) | 715 | 4 | Biphasic | P Aspart30 (×2) | 61.7 | 63 | 8.4% | 0.62 | ||||||
| Basal-bolus | Aspart (×3) + Detemir | 60.3 | 63 | No | ≤ | No | 8.5% | Yes | ITT | 2 | 0.88 | |||
| Buse, 2009 (35) | 2091 | 6 | Biphasic | P Lispro25 (×2) | 57 | 52.8 | 9.1% | 0.47 | ||||||
| Basal | Glargine | 57 | 52.8 | Met/Su/Tzd | ≤ | Yes | 9.0% | Yes | ITT | 4 | 0.4 | |||
| Raz, 2009 (36) | 1115 | 31 | Basal | P Glargine | 60 | 63.3 | 8.3% | 0.52 | ||||||
| Prandial | Lispro (×3) | 60 | 63.3 | No | < | No | 8.4% | Yes | ITT | 4 | 0.60 | |||
| Strojek, 2009 (37) | 480 | 6 | Basal | P Glargine | 56.1 | 41.2 | Met + | 8.5% | 0.29 | |||||
| Biphasic | Aspart30 (×1) | 55.9 | 46.8 | Glimep | < | Yes | 8.5% | Yes | ITT | 2 | 0.32 | |||
| Holman, 2009 (38) | 698 | 36 | Biphasic | P Aspart30 (×2) + Aspart | 61.7 | 64.1 | 8.6% | 0.78 | ||||||
| Basal-bolus | Aspart (×3) + Detemir | 61.7 | 64.1 | No | ≤ | No | 8.6% | Yes | ITT | 4 | 0.97 |
| Trials (first author, year) . | N . | Mo . | Insulin regimen . | Design analog (shot/day) . | Age(years) . | Male (%) . | OHAs . | < /≤ 7% . | Naïve . | Start HbA1c . | Titration . | Statistics . | Quality score . | Insulin dose (units/kg) . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Malone, 2004 (23) | 105 | 4 | Biphasic | CO Lispro25 (×2) | 55.3 | 62.3 | 8.7% | 0.62 | ||||||
| Basal | Glargine | 55.3 | 62.3 | Met | ≤ | Yes | 8.7% | No | No ITT | 3 | 0.57 | |||
| Malone, 2005 (24) | 97 | 4 | Biphasic | CO Lispro25 (×2) | 59.3 | 42 | 8.5% | 0.42 | ||||||
| Basal | Glargine | 59.3 | 42 | Met | ≤ | No | 8.5% | No | ITT | 2 | 0.28 | |||
| Raskin, 2005 (25) | 233 | 6 | Biphasic | P Aspart30 (×2) | 52.6 | 53 | 9.7% | 0.82 | ||||||
| Basal | Glargine | 52.3 | 57 | Met + Pio | < | Yes | 9.8% | Yes | ITT | 2 | 0.55 | |||
| Kann, 2006 (26) | 255 | 6 | Biphasic | P Aspart30 (×2) | 61.5 | 53.9 | 9.2% | 0.39 | ||||||
| Basal | Glargine | 61 | 48.8 | Glimepiride | < | Mix | 8.9% | No | ITT | 2 | 0.39 | |||
| Jacober, 2006 (27) | 60 | 4 | Biphasic | CO Lispro50 (×2) + Lispro25 | 54.9 | 56.7 | 9.2% | 0.35 | ||||||
| Basal | Glargine | 54.9 | 56.7 | Met/Su/Tzd | ≤ | Yes | 9.2% | No | No ITT | 2 | 0.28 | |||
| Kazda, 2006 (28) | 107 | 6 | Biphasic | P Lispro50 (×3) | 59.4 | 54 | 8.1% | 0.59 | ||||||
| Basal | Glargine | 59.4 | 54 | No | < | Yes | 8.1% | No | ITT | 2 | 0.43 | |||
| Kazda, 2006 (28) | 106 | 6 | Biphasic | P Lispro50 (×3) | 59.4 | 54 | 8.1% | 0.59 | ||||||
| Prandial | Lispro (×3) | 59.4 | 54 | No | < | Yes | 8.2% | No | ITT | 2 | 0.50 | |||
| Kazda, 2006 (28) | 105 | 6 | Prandial | P Lispro (×3) | 59.4 | 54 | 8.2% | 0.50 | ||||||
| Basal | Glargine | 59.4 | 54 | No | < | Yes | 8.1% | No | ITT | 2 | 0.43 | |||
| Holman, 2007 (29) | 469 | 12 | Biphasic | P Aspart30 (×2) | 61.7 | 64.1 | 8.6% | 0.53 | ||||||
| Basal | Detemir | 61.7 | 64.1 | Met + Su | ≤ | Yes | 8.4% | Yes | ITT | 4 | 0.49 | |||
| Holman, 2007 (29) | 474 | 12 | Biphasic | P Aspart30 (×2) | 61.7 | 64.1 | 8.6% | 0.53 | ||||||
| Prandial | Aspart (×3) | 61.7 | 64.1 | Met + Su | ≤ | Yes | 8.6% | Yes | ITT | 4 | 0.61 | |||
| Holman, 2007 (29) | 472 | 12 | Prandial | P Aspart (×3) | 61.7 | 64.1 | 8.6% | 0.61 | ||||||
| Basal | Detemir | 61.7 | 64.1 | Met + Su | ≤ | Yes | 8.4% | Yes | ITT | 4 | 0.49 | |||
| Robbins, 2007 (30) | 315 | 6 | Biphasic | P Lispro50 (×3) | 57.7 | 49.8 | 7.8% | 0.7 | ||||||
| Basal | Glargine | 57.7 | 49.8 | Met | ≤ | No | 7.8% | Yes | ITT | 4 | 0.6 | |||
| Bretzel, 2008 (31) | 418 | 10.5 | Prandial | P Lispro (×3) | 59.7 | 59 | 8.7% | 0.53 | ||||||
| Basal | Glargine | 60 | 52 | Met, Su | ≤ | Yes | 8.7% | Yes | ITT | 4 | 0.50 | |||
| Hirao, 2008 (32) | 117 | 6 | Biphasic | P Aspart30 (×2) | 58.5 | 58.7 | 10.6% | — | ||||||
| Prandial | Lispro (×3) | 57.9 | 61.2 | No | < | Yes | 10.6% | No | No ITT | 2 | — | |||
| Rosenstock, 2008 (33) | 374 | 6 | Biphasic | P Lispro50 (×3) | 55.4 | 53 | 8.8% | 1.2 | ||||||
| Basal-bolus | Lispro (×3) + Glargine | 54 | 52 | No Su | < | No | 8.9% | Yes | Complete | 3 | 1.4 | |||
| Liebl, 2009 (34) | 715 | 4 | Biphasic | P Aspart30 (×2) | 61.7 | 63 | 8.4% | 0.62 | ||||||
| Basal-bolus | Aspart (×3) + Detemir | 60.3 | 63 | No | ≤ | No | 8.5% | Yes | ITT | 2 | 0.88 | |||
| Buse, 2009 (35) | 2091 | 6 | Biphasic | P Lispro25 (×2) | 57 | 52.8 | 9.1% | 0.47 | ||||||
| Basal | Glargine | 57 | 52.8 | Met/Su/Tzd | ≤ | Yes | 9.0% | Yes | ITT | 4 | 0.4 | |||
| Raz, 2009 (36) | 1115 | 31 | Basal | P Glargine | 60 | 63.3 | 8.3% | 0.52 | ||||||
| Prandial | Lispro (×3) | 60 | 63.3 | No | < | No | 8.4% | Yes | ITT | 4 | 0.60 | |||
| Strojek, 2009 (37) | 480 | 6 | Basal | P Glargine | 56.1 | 41.2 | Met + | 8.5% | 0.29 | |||||
| Biphasic | Aspart30 (×1) | 55.9 | 46.8 | Glimep | < | Yes | 8.5% | Yes | ITT | 2 | 0.32 | |||
| Holman, 2009 (38) | 698 | 36 | Biphasic | P Aspart30 (×2) + Aspart | 61.7 | 64.1 | 8.6% | 0.78 | ||||||
| Basal-bolus | Aspart (×3) + Detemir | 61.7 | 64.1 | No | ≤ | No | 8.6% | Yes | ITT | 4 | 0.97 |
CO, crossover group; P, parallel group; OHAs, oral hypoglycemic agents; Met, metformin; Su, sulfonylurea; Tzd, thiazolidinedione; ITT, intention to treat.