Table 1.
Study quality and risk of bias assessment
| Study | Sponsor | Method of randomization | Double blinding | Description of lost to follow-up | Allocation concealment | Type of analysis | Total Jadad score |
|---|---|---|---|---|---|---|---|
| IGlar + OAD versus NPH + OAD | |||||||
| Hsia [39] | NIH | No description | Open labeled | Sufficient | Unclear | ITT; PP | 2/5 |
| Forst [40] | Sanofi-Aventis | No description | Open labeled | Sufficient | Unclear | PP | 2/5 |
| Esposito [48] | Second University of Naples | Adequate | Open labeled | Sufficient | Adequate | PP | 3/5 |
| Eliaschewitz [41] | Sanofi-Aventis | No description | Open labeled | Sufficient | Unclear | mITT | 2/5 |
| Fritsche [42] | Sanofi-Aventis | Adequate | Open labeled | Sufficient | Unclear | mITT | 3/5 |
| Yki-Järvinen [43] | Sanofi-Aventis | Adequate | Open labeled | Sufficient | Unclear | mITT | 3/5 |
| Riddle [44] | Sanofi-Aventis | Adequate | Open labeled | Sufficient | Adequate | mITT | 3/5 |
| Massi-Bendetti [45] | Grant from Hoechst Marion Russel Deutschland Clinical Development | Adequate | Open labeled | Sufficient | Adequate | mITT | 3/5 |
| Strojek [49] | Eli Lilly | No description | Open labeled | Sufficient | Unclear | mITT | 2/5 |
| IGlar + bolus ± OAD versus NPH + bolus ± OAD | |||||||
| Rosenstock [47] | Sanofi-Aventis | No description | Open labeled | Sufficient | Unclear | ITT | 2/5 |
| Koivisto [46] | Eli Lilly | No description | Open labeled | Sufficient | Unclear | mITT and PP/mITT | 2/5 |
| IGlar + OAD ± bolus versus NPH + OAD ± bolus | |||||||
| Rosenstock [51] | Sanofi-Aventis | Adequate | Open labeled | Sufficient | Adequate | mITT; PP | 3/5 |
| IGlar + bolus ± OAD versus IDet + bolus ± OAD | |||||||
| Hollander [67] | Novo Nordisk | Adequate | Open labeled | Sufficient | Adequate | mITT | 3/5 |
| Raskin [68] | Novo Nordisk | No description | Open labeled | Insufficient | Unclear | mITT | 1/5 |
| IGlar + OAD versus IDet + OAD | |||||||
| Rosenstock [65] | Novo Nordisk | Adequate | Open labeled | Sufficient | Adequate | ITT or mITT/ITT | 3/5 |
| Swinnen [66] | Sanofi-Aventis | Adequate | Open labeled | Sufficient | Adequate | mITT, PP | 3/5 |
| IGlar + OAD versus MIX | |||||||
| Al-Shaikh [52] | n/a | No description | Open labeled | Sufficient | Unclear | ITT | 2/5 |
| Janka [53] | Sanofi-Aventis | Adequate | Open labeled | Sufficient | Adequate | mITT | 3/5 |
| Schiel [54] | Sanofi-Aventis | Adequate | Open labeled | Sufficient | Adequate | mITT | 3/5 |
| IGlar + OAD versus MIX +OAD | |||||||
| DURABLE 1 [55] | Eli Lilly | Adequate | Open labeled | Sufficient | Adequate | mITT/mITT | 3/5 |
| Kann [56] | Novo Nordisk | Properly described | Open labeled | Insufficient | Unclear | mITT | 1/5 |
| Raskin [57] | Novo Nordisk | Properly described | Open labeled | Sufficient | Unclear | mITT | 2/5 |
| Robbins [58] | n/a | Adequate | Open labeled | Sufficient | Adequate | mITT | 3/5 |
| Strojek [59] | Novo Nordisk | Adequate | Open labeled | Sufficient | Adequate | mITTi PP | 3/5 |
| IGlar + bolus ± OAD versus MIX ± OAD | |||||||
| Bowering [60] | Eli Lilly | No description | Open labeled | Sufficient | Unclear | PP and mITT/mITT | 2/5 |
| DURABLE 2 [61] | Eli Lilly | Adequate | Open labeled | Sufficient | Adequate | mITT/mITT | 3/5 |
| GINGER [62] | Sanofi-Aventis | Adequate | Open labeled | Sufficient | Adequate | mITT/mITT | 3/5 |
| Jain [63] | Eli Lilly | Adequate | Open labeled | Sufficient | Adequate | ITT | 3/5 |
| Rosenstock [64] | Eli Lilly | Adequate | Open labeled | Sufficient | Adequate | PP/ITT | 3/5 |